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What is a Feasibility Study and its Importance?

This blog talks about how a study that assesses the potential success of a proposed project. Let’s dive in to learn how to conduct this study and comprehend what determines the viability of a project. It will help you understand how the Feasibility Study evaluates the necessity of a project in terms of legal aspects. Read more!

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A Feasibility Study is a crucial assessment that is during Project Management conducted to determine the viability and potential success of a project. By thoroughly examining such factors, stakeholders can make informed decisions regarding the project’s feasibility. Apart from the technical and financial considerations, this study ensures a project’s compliance with relevant laws, regulations and industry standards. To give you a better overview, this blog will talk about the multiple aspects associated with this. So, let’s dive in to comprehend the significance of a Feasibility Study. After reading this blog, stakeholders can make well-informed decisions that enhance the chances of a project’s success.

Table of Contents 

1) Feasibility Study - An overview

2) Importance of a Feasibility Study 

3)  Types of Feasibility Studies

4) What is included in a Feasibility Study report?

5) Examples of a Feasibility Study

6) Seven steps to do a Feasibility Study

7) Conclusion

Feasibility Study - An overview

A Feasibility Study is an initial investigation into the potential benefits and viability of a project or endeavour. An impartial appraisal that looks at a project's technical, financial, legal, and environmental elements is what this study provides.

Importance of a Feasibility Study

A Feasibility Study may reveal novel concepts that fundamentally alter the Scope of a Project . Feasibility Studies are of the greatest importance in the decision-making process when it comes to projects, businesses, and investments. They are mostly structured assessments that are focused on various aspects of a proposed project`s Feasibility. The following are some of its advantages:

a) Increases the focus of project teams 

b) Finds fresh opportunities 

c) Gives important information to help make a "go/no-go" choice. 

d) Reduces the number of available business options 

e) Finds a good cause to start the project

f) Increases the success rate through the assessment of several factors 

g)  Assists in making project decisions 

h) Identifies grounds for not moving forward

Types of Feasibility Studies

Technical Feasibility Study

A technical Feasibility Study aims to verify whether the organisation is eligible to use its technical in-house resources and expertise to perform successfully. This assessment involves scrutinising various aspects, including the following:

a) Production capacity: Does the company have the resource base to produce that number of products and services for the customers? 

b) Facility needs: Will today’s facilities fulfil the standards required, or will new facilities be constructed?

c) Raw materials and supply chain: Are there enough purchases, and have the organisation maintained a supply chain?

d) Regulatory compliance: Does the Project Execution follow the relevant guidelines and professionals bear the relevant certifications to meet the requirements and the industry standards?

Economic Feasibility Study 

It is a financial Feasibility Study that primarily examines the project's financial viability. The economic Feasibility Study typically involves several steps:

a) Determining capital requirements: Calculate funding collection, overhead, and other capital.

b) Cost breakdown: Determining and listing all the project costs including the purchase of materials, hardware, labour, and overheard costs are too.

c) Funding sources: Trying out a variety of possible solutions like banks, stakes, or grants.

d) Revenue projection: By using prediction tools such as a cost-benefit analysis or business forecasting to get the level of income, return on investment and profit margin.

e) Financial analysis: Projecting the performance of the Project based on means that are related to a financial analysis and are characterised by the utilisation of such things as cash flow statements, balance sheets and financial projections.

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Legal Feasibility Study  

Legal Feasibility is a type of analysis that seeks to confirm that a pProject follows all the relevant laws and regulations. Key considerations include: 

a) Regulatory compliance: Briefing the whole project team about all required laws and regulations that the project has to comply with. 

b) Business structure: Assessing the legal systems (e.g., LLCs vs. corporations) that would best protect liability, governance, and minimising taxation, if any. 

Operational Feasibility Study

An operational Feasibility Study looks at how effectively a product will meet its needs. It also talks about how easy it will be to use and maintain once it is in place. In addition, this study enumerates the necessity of evaluating a product's utility and the response and suggestions of  application development team.

Scheduling Feasibility Study

Proposed project schedules and deadlines are the main subject of a scheduling a Feasibility Study. This evaluation concerns how long team members will need to complete the project. It also highly impacts the business because if the programme isn't finished on time, the planned result might not be realised.

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What is included in a Feasibility Study report? 

You should make a Feasibility Study report before starting a project. This way you can analyse if your business idea is really viable and will bring you success. When you conduct this study, you would have to consider lots of factors such as if the people are going to buy your product or service, how much competition is out there, if the company can afford it and so on. 

The Feasibility Study must include things like how much technology and resources you need and how much you can hope to earn from your investment. The results of this study are put together in a report, which usually includes the following sections:

a) Executive summary

b) Approach to marketing

c) Organisation/staffing

Examples of a Feasibility Study

Feasibility Study has helped decide if big ideas can work. Here are two examples:

University Science Building Upgrade

This example is about a university that wanted to upgrade its old science building from the 1970s. They thought it was outdated and needed a change. To implement this, they evaluated different options and determined how much they would approximately cost. Some people were worried about the project being too expensive or its potential to causeissues in the community. The study also analysed what technology the new building would  require, and how effectively it would help students, and also, if it would attract more students.

Along with this, they looked at the financial aspect too, as to how they would sponsor for it and if they would make more money from having additional students. The study showed that the project could work, so they went ahead with the upgrade.

High-speed Rail Project

This example  is timed when the Washington State Department of Transportation wanted to see if they could build a fast train connecting Vancouver, Seattle, and Portland. To initiate this, they first focused on how to make decisions about the project in the future.

They discussed it with several people and groups to ensure everyone was okay with the plan. Later, they looked at how to pay for it and thought it would cost between $24 billion and $42 billion. They would get money from the government and maybe from loans and investors.

The study showed that the train could bring lots of good things like better jobs and less traffic. They started looking into this in 2016 and finished the study in 2020. They then shared the report with the government.

Seven steps to do a Feasibility Study

As Feasibility Study is a crucial step in determining a potential of a project, it involves a substantial period of time and resources. Let’s take you through some of the steps involved in the following points:

1) Do a preliminary analysis and define the scope of the study

Before going through a Feasibility Study, it is wise that you do just one small check. The time and resources involved in Feasibility Studies may be burdensome; hence, it is imperative to determine if it is worth it as early as possible.

Through this form, one can establish whether the study holds awarding potential and who else should be involved on a higher level. You further this stage by answering questions like what you might win, what pitfalls you will face, and what you need for the success of the project.

2) Prepare a projected income statement

First, while doing a Feasibility Study, you should obtain the income statement projection. In this, the statement calculates earnings and expenditures in subsequent one-year amounts. It is made up of the sum of what you will surely get and the cost you will need to cover.

Smaller businesses tend to need marketing strategies to grow into bigger companies. These facts are extremely important because they help business owners make smart decisions regarding the stage of the business.

3) Carry out market research

Market research is of paramount importance or, naturally, it will be of no use when developing the Feasibility Study. Primarily, it operates to ascertain the viability of the project. This point tells you time, which gives you knowledge of the current market state: Who your customers are, who your competitors are, how big the market is, and how many of it you could have. One way of doing this market research is by asking people questions, referring to experts, and checking very broad social media and other public info to find out what's going on.

4) Organisation and operations plan

Once you've figured out how the market behaves and the scope of your organisation, you can draft the setup of your plan. The detailed work plan for the project will provide the answer to how it will work in a practical form. It tests three aspects of your project, like whether it can be run, whether it is cost-effective, whether it complies with the law, and whether the technology fits.

This is to help you comprehend everything you can do and what you may require to get this project going, for example, the equipment, the materials to start the project, additional costs, and if you need to hire or train people. If you need to, you may make that change if the information you have brought is enough.

5) Calculate and prepare the initial balance of expected revenue and expenses

In this step, you must be expert in handling things from the financial part. You’ll make estimates on how much you may initially spend starting up your project, and then how much your project could make and spend based on that estimate. Among the many issues involved are such as the amount of money you are receiving from your customers, money you owe to others and assets that you own. 

Fixed costs, such as variable costs that will change based on the number of goods you produce, and equipment costs also need to be factored in money you may borrow or pay for land and service other companies. Keeping this in mind, you should also consider your business’ off seasons and how much risk you are willing to take. These calculations save a lot of time and effort and can be used to answer the most difficult questions of Feasibility.

6) Review and analyse all data

After going through all the steps, it's crucial to do a thorough review and analysis. This helps ensure that everything is in order and there's nothing that needs adjusting. Take a moment to carefully look back at your work, including the income statement, and compare it with your expenses and debts. Ask yourself: Does everything still seem realistic?

This is also the perfect opportunity to consider any risks that might come up and create contingency plans to handle them. By doing this, you'll be better prepared for any unexpected challenges that may arise.

7) Make a go/No-go decision

Now, it's time to decide if the project can work. This might seem simple, but all the work you've done so far leads up to this moment of decision-making. Before making the final call, there are a few more things to think about. First, consider if the project is worth the time, effort, and money you'll be putting into it. Is the commitment worth it?

Secondly, think about whether the project fits with what your organisation wants to achieve in the long run. Does it align with the organisation’s strategic goals and plans? These factors are essential to consider before making your decision.

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Conclusion 

You are now more familiar with how a well-executed Feasibility Study is a cornerstone of informed decision-making in Project Management and business ventures. It acts as a critical guide, helping organisations assess the practicality and viability of their initiatives, ultimately minimising risks and increasing the likelihood of success. 

Frequently Asked Questions

Employers value skills like analysis, problem-solving, attention to detail, and communication in Feasibility Study specialists. They need to be good at crunching numbers, finding solutions, and explaining complex ideas clearly.

Many industries need expertise in Feasibility Studies, like Construction, Healthcare, Tech, and more. It helps decide if projects are doable.

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From Idea to Innovation: What Is a Feasibility Study In Research

Learn the process behind feasibility study in research, how it helps research projects, and the factors that make up a successful project.

Have you ever thought of doing something but wondered whether it’s doable or not? Obviously, there will be several constraints when we wish to do something unique. To understand all these constraints and to check whether the idea that we have in our mind is beneficial or not, we do this preparatory work called a feasibility study.

A feasibility study is like a reality check for your idea, helping you determine if it’s really worth pursuing. In this article, we will discuss what is a feasibility study in research , various aspects of the feasibility study, how it is engaged, how it has to be checked, and how it helps us create a perfect model for our idea.

What is a Feasibility Study in Research? 

A feasibility study is an in-depth assessment conducted to determine the practicality and viability of a proposed project or idea. It involves evaluating various factors such as technical, economic, legal, operational, and scheduling aspects to ascertain whether the project can be successfully implemented.

The purpose of a feasibility study is to provide objective and unbiased information to decision-makers, enabling them to make informed choices regarding the project’s future. It helps identify potential risks, challenges, and opportunities associated with the undertaking, allowing stakeholders to gauge its potential outcomes.

By conducting a feasibility study, decision-makers can determine if the project aligns with organizational goals, identify potential hurdles, and develop contingency plans. This systematic assessment ensures that resources are allocated efficiently and that projects with a high chance of success are pursued.  

What is the Purpose of the Feasibility Study?

A feasibility study serves as a vital tool for assessing the practicality and viability of a proposed project or initiative before committing significant resources to its implementation. It is a comprehensive evaluation that considers various factors such as technical, economic, legal, operational, and scheduling aspects, providing stakeholders with crucial insights to make informed decisions.

First and foremost, a feasibility study helps identify the project’s objectives and determine whether they align with the organization’s overall goals. It allows stakeholders to assess the project’s potential benefits and weigh them against the associated risks. By conducting a feasibility study, decision-makers can gain a clearer understanding of the project’s potential impact on the organization’s resources, capabilities, and market position.

Examination of technical feasibility

One key aspect of a feasibility study is the examination of technical feasibility. This involves evaluating whether the proposed project can be implemented using available technology, infrastructure, and expertise. It helps identify potential technical constraints or challenges that may arise during project execution and allows for appropriate contingency planning.

Furthermore, a feasibility study evaluates the economic viability of a project. It involves conducting a detailed cost-benefit analysis to determine the financial implications associated with the project. This analysis helps stakeholders understand the potential return on investment, project profitability, and the timeline for cost recovery.

Related Article: What is Geospatial Analysis? The Plan Before the Actual Plan

Types of Feasibility Studies

There are several types of feasibility studies, each with its own specific focus and objectives. Some of the most common types of feasibility studies include:

• Technical feasibility study: This type of study assesses whether the proposed project can be implemented using available technology, infrastructure, and expertise. It identifies potential technical constraints or challenges that may arise during project execution and allows for appropriate contingency planning.
• Economic feasibility study: This type of study involves conducting a detailed cost-benefit analysis to determine the financial implications associated with the project. It helps stakeholders understand the potential return on investment, project profitability, and the timeline for cost recovery.
• Legal feasibility study: This type of study examines the legal and regulatory requirements associated with the project. By identifying any legal hurdles or compliance issues early on, organizations can ensure that the project aligns with legal frameworks and minimizes the risk of legal complications down the line.
• Operational feasibility study: This type of study assesses whether the project can be smoothly integrated into existing systems and processes. It examines factors such as staffing requirements, training needs, and potential impacts on day-to-day operations.
• Scheduling feasibility study: This type of study helps establish a realistic timeline for project completion. It considers the availability of resources, dependencies, and potential bottlenecks, allowing stakeholders to develop a well-structured project plan and set achievable milestones.
• Market feasibility study: This type of study evaluates the potential demand for the proposed project in the marketplace. It examines factors such as customer preferences, competition, and market trends to determine whether the project is likely to be successful.
• Environmental feasibility study: This type of study assesses the potential environmental impacts of the proposed project. It examines factors such as air and water quality, habitat destruction, and waste management to ensure that the project is sustainable and environmentally responsible.

Overall, the type of feasibility study conducted will depend on the specific objectives of the proposed project and the information needed to make informed decisions about its implementation.

How to Conduct a Feasibility Study?

A feasibility study is an important step in evaluating the viability of a proposed project or business venture. The study is typically conducted before any significant investment is made to determine whether the project is feasible, both financially and operationally. Here are the general steps to conduct a feasibility study:

Step 1 – Define the scope of the study

Clearly define the objectives of the feasibility study and the specific questions that need to be answered. Identify the stakeholders who will be involved in the study and their roles and responsibilities.

Step 2 – Conduct market research

Research the market and competition to determine the potential demand for the product or service, as well as the size and characteristics of the target market. Analyze the existing competition and identify any gaps in the market that the proposed project could fill.

Step 3 – Evaluate the operational feasibility

Assess the operational feasibility of the proposed project, including the availability of resources, skills, and expertise needed to execute the project.

Step 4 – Identify potential risks

Identify potential risks and challenges that could impact the success of the proposed project. Develop contingency plans to mitigate these risks.

Step 5 – Make recommendations

Based on the results of the feasibility study, make recommendations about whether or not to move forward with the proposed project and, if so, what steps should be taken to ensure its success.

It’s important to note that the specific steps and level of detail required for a feasibility study may vary depending on the nature and complexity of the project. A feasibility study is a critical step in the decision-making process and should be conducted thoroughly and objectively to ensure that all aspects of the proposed project have been evaluated.

How to Write a Feasibility Study?

Writing a feasibility study involves conducting a systematic analysis to determine the viability and potential success of a proposed project or initiative. Here are the steps to help you write a feasibility study: 

• Executive Summary: Provide a brief overview of the project, its objectives, and the purpose of the feasibility study.
• Introduction : Describe the background and context of the project, including its goals, scope, and any relevant background information.
• Project Description: Provide a detailed description of the project, outlining its objectives, deliverables, and expected outcomes. Include information on the target audience or beneficiaries.
• Market Analysis: Assess the market conditions and demand for the proposed project. Identify the target market, competitors, and potential customers. Analyze market trends, growth prospects, and any potential challenges or risks.
• Technical Feasibility: Evaluate the technical aspects of the project, such as the required infrastructure, technology, resources, and expertise. Determine if the necessary resources and capabilities are available or can be acquired within the project’s constraints.
• Financial Feasibility: Conduct a thorough financial analysis of the project. Estimate the initial investment costs, operational expenses, and projected revenues. Evaluate the project’s profitability, return on investment (ROI), payback period, and other financial indicators. Consider potential funding sources and financing options.
• Organizational Feasibility: Assess the project’s compatibility with the existing organizational structure and capabilities. Evaluate the availability of skilled personnel, management support, and any potential impact on the organization’s operations. Consider any legal, regulatory, or compliance requirements.
• Risk Analysis: Identify and evaluate potential risks and uncertainties associated with the project. Analyze both internal and external factors that may impact the project’s success. Develop risk mitigation strategies and contingency plans.
• Implementation Plan: Outline a detailed plan for implementing the project. Define the necessary steps, timelines, and responsibilities. Consider resource allocation, project management methodologies, and any potential challenges during the implementation phase.
• Summarize your findings: Write a clear and concise summary of your findings and conclusions. This should include an assessment of the project’s overall feasibility, a description of any risks or challenges, and a recommendation on whether or not to proceed with the project.

Examples of Feasibility Studies

It typically examines various aspects such as technical, economic, legal, operational, and scheduling factors. Here are some examples of feasibility studies conducted for different purposes: 

• New Business Venture: A study to determine the feasibility of opening a new restaurant, including analysis of market demand, location suitability, competition, and financial projections.
• Real Estate Development: An evaluation of the feasibility of constructing a shopping mall, considering factors such as land availability, market demand, construction costs, potential tenants, and expected return on investment.
• Renewable Energy Project: Assessing the feasibility of establishing a solar power plant, including examination of solar resources, land requirements, grid connectivity, financial analysis, and environmental impact.
• Information Technology System: A study to determine the feasibility of implementing a new software system within an organization, analyzing factors like system requirements, compatibility, cost-benefit analysis, and potential impact on existing operations.

These are some examples of feasibility studies and it is very important to note that though the process looks the same for every domain of work, the concept will be different for each one of them so it is important to analyze the domain before getting to work on it.

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About Sowjanya Pedada

Sowjanya is a passionate writer and an avid reader. She holds MBA in Agribusiness Management and now is working as a content writer. She loves to play with words and hopes to make a difference in the world through her writings. Apart from writing, she is interested in reading fiction novels and doing craftwork. She also loves to travel and explore different cuisines and spend time with her family and friends.

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What Is a Feasibility Study? How It Ensures Project Success

In this post

What is the purpose of a feasibility study?

Types of feasibility studies.

• How to conduct a feasibility study?

Shark Tank was invented for a reason. A famous quote goes along these lines - "Execution is more important than planning. Planning is more important than ideas." 

There can be multiple interpretations of the saying (as with any quote), but the essence of it seems to be the importance of coming up with an idea that has a clear return on investment (ROI) and is implemented in a way that sets the business up for success.

Think of feasibility studies as an approach that boosts the value of an idea and prepares it to perform at its optimal level, thus leaving the essence of our quote intact. Feasibility studies are an integral part of the ideation, planning, and execution process, and when combined with technology like project management software , every project delivers on its objectives.

What is a feasibility study?

A feasibility study consists of research conducted before the approval of a project. It is essential to the project life cycle development as it helps determine the likelihood of success before you’ve spent your resources on a potential lost cause. 

The study helps determine a project's viability by looking at cost, resource requirements, return on investment, and necessary business factors to ensure its practicality and use cases.

You have an incredible project idea but are unsure whether it aligns with current business goals - so do you give up? No! You get to workshop your idea through a feasibility study to identify the project's strengths, weaknesses, and overall outcomes.

The aim of feasibility studies is to assess project objectives and opportunity costs to help choose the best alternative action. Before executing any business proposition, it is critical to check whether the plan can be achieved by the organization. Feasibility studies simplify project estimation and potential roadblocks by considering various factors, such as available resources, competencies, costs, and time frames.

By analyzing business performance and predicted outcomes, feasibility studies reduce the risk of failures and help bridge gaps in existing business models. Additionally, they force stakeholders to think through every idea in detail to make it easier to secure investment, improve performance, and make a strong case for the proposition.

Want to learn more about Project Management Software? Explore Project Management products.

Feasibility studies are essential to determine the opportunities and threats associated with the proposed business idea. Since the scope of evaluation can depend on the project and type and size of the company, feasibility studies are categorized into four main types.

• Technical feasibility:  This study answers the question, "Are the resources this project requires accessible?" The technical feasibility study lists the tools and labor needed to execute the idea successfully. Some projects require while complex ideas may benefit from visualizations like Gantt charts.
• Financial feasibility: The cost evaluation study answers the question, "How much will the resources for the project cost?" Assessing financial feasibility is critical to understanding the estimated income from the project, managing budgets , and determining the true cost of the project you hope to undertake.
• Market feasibility: A market assessment study answers questions like, "Who is the target audience for this project?" and "Is this the right market environment to launch this project?" Carrying out market research surveys minimizes the risk investments, helps identify trends, and is key to staying ahead of competitors when implementing new strategies.
• Organizational feasibility: This part of a feasibility study seeks to answer the question, "Who is working on this project, and in what role?" Outlining the organizational structure of a project is important to evaluate the ability of the company's management team and their areas of interest and expertise.

How to conduct a feasibility study

Feasibility studies consider all project factors to determine the likelihood of a team achieving its goals successfully. They help in answering questions such as:

• Is the project cost-efficient?
• Will the current state of the economy allow for success?
• Does it make sense to pursue this venture at this particular time?

Having these answers helps assess whether your proposed project or strategy is a necessary and practical solution.

To conduct a feasibility study, there are 3 main steps.

1. Define project goals

Start your feasibility study by defining the project and outlining its goal and deliverables.  A best practice to follow is to use the goal-setting process to evaluate necessary project steps.

Depending on where your company puts the feasibility study in the project life cycle, your project sponsors may have to choose between several studies to decide which ones to execute. By clearly describing your proposed solution, you can increase the chances of stakeholders picking your suggested course of action.

2. Run a preliminary study 

The most important aspect of a feasibility study is to determine the project's true feasibility  by conducting preliminary research.

For example, let's assume you are trying to get buy-in from senior leadership on redesigning the website. Before diving head first into setting up meetings with the C-suite, take a few steps back and analyze the various requirements for the venture. Make a detailed plan regarding the rationale behind the redesign, headcount required to help the project, necessary tools, and estimated time and cost.

Collect as much data as possible in the early stages of the study to create a strong value proposition . Make sure to note any risk factors and obstacles identified, along with probable solutions to nudge stakeholders towards giving you the green flag to proceed.

One of the biggest business considerations when launching new ideas is financial. This is why it is imperative that the preliminary analyses include a projected revenue that takes into account operating costs and net profits .

3. Perform a business analysis

There can be a thousand incredible ideas, but if only 5 of those can be achieved and implemented with the resources and goals of the business at a particular time, those are your projects.

When thinking of new ideas and endeavors, it may be helpful to assess whether the project aligns with the greater business goals or is more suited to a specific team's roadmaps. Projects impacting the organization's bottom line are more likely to be moved forward rather than ideas that benefit a small group. For example, a new product launch strategy will receive more attention than the request for an expensive tool set for a single department.

Things to consider during a business analysis

• Executive summary : Detailed description of the project, proposition, or plan.
• Project financials : Provide information regarding project costs and expected ROIs through financial analyses.
• Marketing strategy : Outline target personas, plans, and tools required to market the project.
• Staffing requirements : Draft an organizational plan detailing human capital needs for the project.
• Schedule and timeline : Include project milestones and interim markers for project completion.

Focus on what's feasible

Back to why Shark Tank was invented - to stop well-meaning people from draining their funds on impractical ventures that can't be scaled.

Taking a few extra moments to analyze an idea in detail and determine the best way to move forward is sometimes the only way to ensure success. Feasibility studies are powerful tools for project management and can help inculcate critical thinking and problem-solving for everyday tasks.

The first step to diving deep into small and big ideas is to conduct a feasibility study. Ready to bring your project to life? Start with the tried and tested project management methodologies . 

Grace Pinegar

Grace Pinegar is a lifelong storyteller with an extensive background in various forms such as acting, journalism, improv, research, and content marketing. She was raised in Texas, educated in Missouri, worked in Chicago, and is now a proud New Yorker. (she/her/hers)

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What is a Feasibility Study and How to Conduct It? (+ Examples)

Appinio Research · 26.09.2023 · 28min read

Are you ready to turn your project or business idea into a concrete reality but unsure about its feasibility? Whether you're a seasoned entrepreneur or a first-time project manager, understanding the intricate process of conducting a feasibility study is vital for making informed decisions and maximizing your chances of success.

This guide will equip you with the knowledge and tools to navigate the complexities of market, technical, financial, and operational feasibility studies. By the end, you'll have a clear roadmap to confidently assess, plan, and execute your project.

What is a Feasibility Study?

A feasibility study is a systematic and comprehensive analysis of a proposed project or business idea to assess its viability and potential for success. It involves evaluating various aspects such as market demand, technical feasibility, financial viability, and operational capabilities. The primary goal of a feasibility study is to provide you with valuable insights and data to make informed decisions about whether to proceed with the project.

Why is a Feasibility Study Important?

Conducting a feasibility study is a critical step in the planning process for any project or business. It helps you:

• Minimize Risks: By identifying potential challenges and obstacles early on, you can develop strategies to mitigate risks.
• Optimize Resource Allocation: A feasibility study helps you allocate your resources more efficiently, including time and money.
• Enhance Decision-Making: Armed with data and insights, you can make well-informed decisions about pursuing the project or exploring alternative options.
• Attract Stakeholders: Potential investors, lenders, and partners often require a feasibility study to assess the project's credibility and potential return on investment.

Now that you understand the importance of feasibility studies, let's explore the various types and dive deeper into each aspect.

Types of Feasibility Studies

Feasibility studies come in various forms, each designed to assess different aspects of a project's viability. Let's delve into the four primary types of feasibility studies in more detail:

1. Market Feasibility Study

Market feasibility studies are conducted to determine whether there is a demand for a product or service in a specific market or industry. This type of study focuses on understanding customer needs, market trends, and the competitive landscape. Here are the key elements of a market feasibility study:

• Market Research and Analysis: Comprehensive research is conducted to gather market size, growth potential , and customer behavior data. This includes both primary research (surveys, interviews) and secondary research (existing reports, data).
• Target Audience Identification: Identifying the ideal customer base by segmenting the market based on demographics, psychographics, and behavior. Understanding your target audience is crucial for tailoring your product or service.
• Competitive Analysis : Assessing the competition within the market, including identifying direct and indirect competitors, their strengths, weaknesses, and market share .
• Demand and Supply Assessment: Analyzing the balance between the demand for the product or service and its supply. This helps determine whether there is room for a new entrant in the market.

2. Technical Feasibility Study

Technical feasibility studies evaluate whether the project can be developed and implemented from a technical standpoint. This assessment focuses on the project's design, technical requirements, and resource availability. Here's what it entails:

• Project Design and Technical Requirements: Defining the technical specifications of the project, including hardware, software, and any specialized equipment. This phase outlines the technical aspects required for project execution.
• Technology Assessment: Evaluating the chosen technology's suitability for the project and assessing its scalability and compatibility with existing systems.
• Resource Evaluation: Assessing the availability of essential resources such as personnel, materials, and suppliers to ensure the project's technical requirements can be met.
• Risk Analysis: Identifying potential technical risks, challenges, and obstacles that may arise during project development. Developing risk mitigation strategies is a critical part of technical feasibility.

3. Financial Feasibility Study

Financial feasibility studies aim to determine whether the project is financially viable and sustainable in the long run. This type of study involves estimating costs, projecting revenue, and conducting financial analyses. Key components include:

• Cost Estimation: Calculating both initial and ongoing costs associated with the project, including capital expenditures, operational expenses, and contingency funds.
• Revenue Projections: Forecasting the income the project is expected to generate, considering sales, pricing strategies, market demand, and potential revenue streams.
• Investment Analysis: Evaluating the return on investment (ROI), payback period, and potential risks associated with financing the project.
• Financial Viability Assessment: Analyzing the project's profitability, cash flow, and financial stability to ensure it can meet its financial obligations and sustain operations.

4. Operational Feasibility Study

Operational feasibility studies assess whether the project can be effectively implemented within the organization's existing operational framework. This study considers processes, resource planning, scalability, and operational risks. Key elements include:

• Process and Workflow Assessment: Analyzing how the project integrates with current processes and workflows, identifying potential bottlenecks, and optimizing operations.
• Resource Planning: Determining the human, physical, and technological resources required for successful project execution and identifying resource gaps.
• Scalability Evaluation: Assessing the project's ability to adapt and expand to meet changing demands and growth opportunities, including capacity planning and growth strategies.
• Operational Risks Analysis: Identifying potential operational challenges and developing strategies to mitigate them, ensuring smooth project implementation.

Each type of feasibility study serves a specific purpose in evaluating different facets of your project, collectively providing a comprehensive assessment of its viability and potential for success.

How to Prepare for a Feasibility Study?

Before you dive into the nitty-gritty details of conducting a feasibility study, it's essential to prepare thoroughly. Proper preparation will set the stage for a successful and insightful study. In this section, we'll explore the main steps involved in preparing for a feasibility study.

1. Identify the Project or Idea

Identifying and defining your project or business idea is the foundational step in the feasibility study process. This initial phase is critical because it helps you clarify your objectives and set the direction for the study.

• Problem Identification: Start by pinpointing the problem or need your project addresses. What pain point does it solve for your target audience?
• Project Definition: Clearly define your project or business idea. What are its core components, features, or offerings?
• Goals and Objectives: Establish specific goals and objectives for your project. What do you aim to achieve in the short and long term?
• Alignment with Vision: Ensure your project aligns with your overall vision and mission. How does it fit into your larger strategic plan?

Remember, the more precisely you can articulate your project or idea at this stage, the easier it will be to conduct a focused and effective feasibility study.

2. Assemble a Feasibility Study Team

Once you've defined your project, the next step is to assemble a competent and diverse feasibility study team. Your team's expertise will play a crucial role in conducting a thorough assessment of your project's viability.

• Identify Key Roles: Determine the essential roles required for your feasibility study. These typically include experts in areas such as market research, finance, technology, and operations.
• Select Team Members: Choose team members with the relevant skills and experience to fulfill these roles effectively. Look for individuals who have successfully conducted feasibility studies in the past.
• Collaboration and Communication: Foster a collaborative environment within your team. Effective communication is essential to ensure everyone is aligned on objectives and timelines.
• Project Manager: Designate a project manager responsible for coordinating the study, tracking progress, and meeting deadlines.
• External Consultants: In some cases, you may need to engage external consultants or specialists with niche expertise to provide valuable insights.

Having the right people on your team will help you collect accurate data, analyze findings comprehensively, and make well-informed decisions based on the study's outcomes.

3. Set Clear Objectives and Scope

Before you begin the feasibility study, it's crucial to establish clear and well-defined objectives. These objectives will guide your research and analysis efforts throughout the study.

Steps to Set Clear Objectives and Scope:

• Objective Clarity: Define the specific goals you aim to achieve through the feasibility study. What questions do you want to answer, and what decisions will the study inform?
• Scope Definition: Determine the boundaries of your study. What aspects of the project will be included, and what will be excluded? Clarify any limitations.
• Resource Allocation: Assess the resources needed for the study, including time, budget, and personnel. Ensure that you allocate resources appropriately based on the scope and objectives.
• Timeline: Establish a realistic timeline for the feasibility study. Identify key milestones and deadlines for completing different phases of the study.

Clear objectives and a well-defined scope will help you stay focused and avoid scope creep during the study. They also provide a basis for measuring the study's success against its intended outcomes.

4. Gather Initial Information

Before you delve into extensive research and data collection , start by gathering any existing information and documents related to your project or industry. This initial step will help you understand the current landscape and identify gaps in your knowledge.

• Document Review: Review any existing project documentation, market research reports, business plans, or relevant industry studies.
• Competitor Analysis : Gather information about your competitors, including their products, pricing, market share, and strategies.
• Regulatory and Compliance Documents: If applicable, collect information on industry regulations, permits, licenses, and compliance requirements.
• Market Trends: Stay informed about current market trends, consumer preferences, and emerging technologies that may impact your project.
• Stakeholder Interviews: Consider conducting initial interviews with key stakeholders, including potential customers, suppliers, and industry experts, to gather insights and feedback.

By starting with a strong foundation of existing knowledge, you'll be better prepared to identify gaps that require further investigation during the feasibility study. This proactive approach ensures that your study is comprehensive and well-informed from the outset.

How to Conduct a Market Feasibility Study?

The market feasibility study is a crucial component of your overall feasibility analysis. It focuses on assessing the potential demand for your product or service, understanding your target audience, analyzing your competition, and evaluating supply and demand dynamics within your chosen market.

Market Research and Analysis

Market research is the foundation of your market feasibility study. It involves gathering and analyzing data to gain insights into market trends, customer preferences, and the overall business landscape.

• Data Collection: Utilize various methods such as surveys, interviews, questionnaires, and secondary research to collect data about the market. This data may include market size, growth rates, and historical trends.
• Market Segmentation: Divide the market into segments based on factors such as demographics, psychographics , geography, and behavior. This segmentation helps you identify specific target markets .
• Customer Needs Analysis: Understand the needs, preferences, and pain points of potential customers . Determine how your product or service can address these needs effectively.
• Market Trends: Stay updated on current market trends, emerging technologies, and industry innovations that could impact your project.
• SWOT Analysis: Conduct a SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis to identify internal and external factors that may affect your market entry strategy.

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Target Audience Identification

Knowing your target audience is essential for tailoring your product or service to meet their specific needs and preferences.

• Demographic Analysis: Define the age, gender, income level, education, and other demographic characteristics of your ideal customers.
• Psychographic Profiling: Understand the psychographics of your target audience, including their lifestyle, values, interests, and buying behavior.
• Market Segmentation: Refine your target audience by segmenting it further based on shared characteristics and behaviors.
• Needs and Pain Points: Identify your target audience's unique needs, challenges, and pain points that your product or service can address.
• Competitor's Customers: Analyze the customer base of your competitors to identify potential opportunities for capturing market share.

Competitive Analysis

Competitive analysis helps you understand the strengths and weaknesses of your competitors, positioning your project strategically within the market.

• Competitor Identification: Identify direct and indirect competitors within your industry or market niche.
• Competitive Advantage: Determine the unique selling points (USPs) that set your project apart from competitors. What value can you offer that others cannot?
• SWOT Analysis for Competitors: Conduct a SWOT analysis for each competitor to assess their strengths, weaknesses, opportunities, and threats.
• Market Share Assessment: Analyze each competitor's market share and market penetration strategies.
• Pricing Strategies: Investigate the pricing strategies employed by competitors and consider how your pricing strategy will compare.

Leveraging the power of data collection and analysis is essential in gaining a competitive edge. With Appinio , you can efficiently gather critical insights about your competitors, their strengths, and weaknesses. Seamlessly integrate these findings into your market feasibility study, empowering your project with a strategic advantage.

Demand and Supply Assessment

Understanding supply and demand dynamics is crucial for gauging market sustainability and potential challenges.

• Market Demand Analysis: Estimate the current and future demand for your product or service. Consider factors like seasonality and trends.
• Supply Evaluation: Assess the availability of resources, suppliers, and distribution channels required to meet the expected demand.
• Market Saturation: Determine whether the market is saturated with similar offerings and how this might affect your project.
• Demand Forecasting: Use historical data and market trends to make informed projections about future demand.
• Scalability: Consider the scalability of your project to meet increased demand or potential fluctuations.

A comprehensive market feasibility study will give you valuable insights into your potential customer base, market dynamics, and competitive landscape. This information will be pivotal in shaping your project's direction and strategy.

How to Conduct a Technical Feasibility Study?

The technical feasibility study assesses the practicality of implementing your project from a technical standpoint. It involves evaluating the project's design, technical requirements, technological feasibility, resource availability, and risk analysis. Let's delve into each aspect in more detail.

1. Project Design and Technical Requirements

The project design and technical requirements are the foundation of your technical feasibility study. This phase involves defining the technical specifications and infrastructure needed to execute your project successfully.

• Technical Specifications: Clearly define the technical specifications of your project, including hardware, software, and any specialized equipment.
• Infrastructure Planning: Determine the physical infrastructure requirements, such as facilities, utilities, and transportation logistics.
• Development Workflow: Outline the workflow and processes required to design, develop, and implement the project.
• Prototyping: Consider creating prototypes or proof-of-concept models to test and validate the technical aspects of your project.

2. Technology Assessment

A critical aspect of the technical feasibility study is assessing the technology required for your project and ensuring it aligns with your goals.

• Technology Suitability: Evaluate the suitability of the chosen technology for your project. Is it the right fit, or are there better alternatives?
• Scalability and Compatibility: Assess whether the chosen technology can scale as your project grows and whether it is compatible with existing systems or software.
• Security Measures: Consider cybersecurity and data protection measures to safeguard sensitive information.
• Technical Expertise: Ensure your team or external partners possess the technical expertise to implement and maintain the technology.

3. Resource Evaluation

Resource evaluation involves assessing the availability of the essential resources required to execute your project successfully. These resources include personnel, materials, and suppliers.

• Human Resources: Evaluate whether you have access to skilled personnel or if additional hiring or training is necessary.
• Material Resources: Identify the materials and supplies needed for your project and assess their availability and costs.
• Supplier Relationships: Establish relationships with reliable suppliers and consistently assess their ability to meet your resource requirements.

4. Risk Analysis

Risk analysis is a critical component of the technical feasibility study, as it helps you anticipate and mitigate potential technical challenges and setbacks.

• Identify Risks: Identify potential technical risks, such as hardware or software failures, technical skill gaps, or unforeseen technical obstacles.
• Risk Mitigation Strategies: Develop strategies to mitigate identified risks, including contingency plans and resource allocation for risk management.
• Cost Estimation for Risk Mitigation: Assess the potential costs associated with managing technical risks and incorporate them into your project budget.

By conducting a thorough technical feasibility study, you can ensure that your project is technically viable and well-prepared to overcome technical challenges. This assessment will also guide decision-making regarding technology choices, resource allocation, and risk management strategies.

How to Conduct a Financial Feasibility Study?

The financial feasibility study is a critical aspect of your overall feasibility analysis. It focuses on assessing the financial viability of your project by estimating costs, projecting revenue, conducting investment analysis, and evaluating the overall financial health of your project. Let's delve into each aspect in more detail.

1. Cost Estimation

Cost estimation is the process of calculating the expenses associated with planning, developing, and implementing your project. This involves identifying both initial and ongoing costs.

• Initial Costs: Calculate the upfront expenses required to initiate the project, including capital expenditures, equipment purchases, and any development costs.
• Operational Costs: Estimate the ongoing operating expenses, such as salaries, utilities, rent, marketing, and maintenance.
• Contingency Funds: Allocate funds for unexpected expenses or contingencies to account for unforeseen challenges.
• Depreciation: Consider the depreciation of assets over time, as it impacts your financial statements.

2. Revenue Projections

Revenue projections involve forecasting the income your project is expected to generate over a specific period. Accurate revenue projections are crucial for assessing the project's financial viability.

• Sales Forecasts: Estimate your product or service sales based on market demand, pricing strategies, and potential growth.
• Pricing Strategy: Determine your pricing strategy, considering factors like competition, market conditions, and customer willingness to pay.
• Market Penetration: Analyze how quickly you can capture market share and increase sales over time.
• Seasonal Variations: Account for any seasonal fluctuations in revenue that may impact your cash flow.

3. Investment Analysis

Investment analysis involves evaluating the potential return on investment (ROI) and assessing the attractiveness of your project to potential investors or stakeholders.

• Return on Investment (ROI): Calculate the expected ROI by comparing the project's net gains against the initial investment.
• Payback Period: Determine how long it will take for the project to generate sufficient revenue to cover its initial costs.
• Risk Assessment: Consider the level of risk associated with the project and whether it aligns with investors' risk tolerance.
• Sensitivity Analysis: Perform sensitivity analysis to understand how changes in key variables, such as sales or costs, affect the investment's profitability.

4. Financial Viability Assessment

A financial viability assessment evaluates the project's ability to sustain itself financially in the long term. It considers factors such as profitability, cash flow, and financial stability.

• Profitability Analysis: Assess whether the project is expected to generate profits over its lifespan.
• Cash Flow Management: Analyze the project's cash flow to ensure it can cover operating expenses, debt payments, and other financial obligations.
• Break-Even Analysis: Determine the point at which the project's revenue covers all costs, resulting in neither profit nor loss.
• Financial Ratios: Calculate key financial ratios, such as debt-to-equity ratio and return on equity, to evaluate the project's financial health.

By conducting a comprehensive financial feasibility study, you can gain a clear understanding of the project's financial prospects and make informed decisions regarding its viability and potential for success.

How to Conduct an Operational Feasibility Study?

The operational feasibility study assesses whether your project can be implemented effectively within your organization's operational framework. It involves evaluating processes, resource planning, scalability, and analyzing potential operational risks.

1. Process and Workflow Assessment

The process and workflow assessment examines how the project integrates with existing processes and workflows within your organization.

• Process Mapping: Map out current processes and workflows to identify areas of integration and potential bottlenecks.
• Workflow Efficiency: Assess the efficiency and effectiveness of existing workflows and identify opportunities for improvement.
• Change Management: Consider the project's impact on employees and plan for change management strategies to ensure a smooth transition.

2. Resource Planning

Resource planning involves determining the human, physical, and technological resources needed to execute the project successfully.

• Human Resources: Assess the availability of skilled personnel and consider whether additional hiring or training is necessary.
• Physical Resources: Identify the physical infrastructure, equipment, and materials required for the project.
• Technology and Tools: Ensure that the necessary technology and tools are available and up to date to support project implementation.

3. Scalability Evaluation

Scalability evaluation assesses whether the project can adapt and expand to meet changing demands and growth opportunities.

• Scalability Factors: Identify factors impacting scalability, such as market growth, customer demand, and technological advancements.
• Capacity Planning: Plan for the scalability of resources, including personnel, infrastructure, and technology.
• Growth Strategies: Develop strategies for scaling the project, such as geographic expansion, product diversification, or increasing production capacity.

4. Operational Risk Analysis

Operational risk analysis involves identifying potential operational challenges and developing mitigation strategies.

• Risk Identification: Identify operational risks that could disrupt project implementation or ongoing operations.
• Risk Mitigation: Develop risk mitigation plans and contingency strategies to address potential challenges.
• Testing and Simulation: Consider conducting simulations or testing to evaluate how the project performs under various operational scenarios.
• Monitoring and Adaptation: Implement monitoring and feedback mechanisms to detect and address operational issues as they arise.

Conducting a thorough operational feasibility study ensures that your project aligns with your organization's capabilities, processes, and resources. This assessment will help you plan for a successful implementation and minimize operational disruptions.

How to Write a Feasibility Study?

The feasibility study report is the culmination of your feasibility analysis. It provides a structured and comprehensive document outlining your study's findings, conclusions, and recommendations. Let's explore the key components of the feasibility study report.

1. Structure and Components

The structure of your feasibility study report should be well-organized and easy to navigate. It typically includes the following components:

• Executive Summary: A concise summary of the study's key findings, conclusions, and recommendations.
• Introduction: An overview of the project, the objectives of the study, and a brief outline of what the report covers.
• Methodology: A description of the research methods , data sources, and analytical techniques used in the study.
• Market Feasibility Study: Detailed information on market research, target audience, competitive analysis, and demand-supply assessment.
• Technical Feasibility Study: Insights into project design, technical requirements, technology assessment, resource evaluation, and risk analysis.
• Financial Feasibility Study: Comprehensive information on cost estimation, revenue projections, investment analysis, and financial viability assessment.
• Operational Feasibility Study: Details on process and workflow assessment, resource planning, scalability evaluation, and operational risks analysis.
• Conclusion: A summary of key findings and conclusions drawn from the study.

Recommendations: Clear and actionable recommendations based on the study's findings.

2. Write the Feasibility Study Report

When writing the feasibility study report, it's essential to maintain clarity, conciseness, and objectivity. Use clear language and provide sufficient detail to support your conclusions and recommendations.

• Be Objective: Present findings and conclusions impartially, based on data and analysis.
• Use Visuals: Incorporate charts, graphs, and tables to illustrate key points and make the report more accessible.
• Cite Sources: Properly cite all data sources and references used in the study.
• Include Appendices: Attach any supplementary information, data, or documents in appendices for reference.

3. Present Findings and Recommendations

When presenting your findings and recommendations, consider your target audience. Tailor your presentation to the needs and interests of stakeholders, whether they are investors, executives, or decision-makers.

• Highlight Key Takeaways: Summarize the most critical findings and recommendations upfront.
• Use Visual Aids: Create a visually engaging presentation with slides, charts, and infographics.
• Address Questions: Be prepared to answer questions and provide additional context during the presentation.
• Provide Supporting Data: Back up your findings and recommendations with data from the feasibility study.

4. Review and Validation

Before finalizing the feasibility study report, conducting a thorough review and validation process is crucial. This ensures the accuracy and credibility of the report.

• Peer Review: Have colleagues or subject matter experts review the report for accuracy and completeness.
• Data Validation: Double-check data sources and calculations to ensure they are accurate.
• Cross-Functional Review: Involve team members from different disciplines to provide diverse perspectives.
• Stakeholder Input: Seek input from key stakeholders to validate findings and recommendations.

By following a structured approach to creating your feasibility study report, you can effectively communicate the results of your analysis, support informed decision-making, and increase the likelihood of project success.

Feasibility Study Examples

Let's dive into some real-world examples to truly grasp the concept and application of feasibility studies. These examples will illustrate how various types of projects and businesses undergo the feasibility assessment process to ensure their viability and success.

Example 1: Local Restaurant

Imagine you're passionate about opening a new restaurant in a bustling urban area. Before investing significant capital, you'd want to conduct a thorough feasibility study. Here's how it might unfold:

• Market Feasibility: You research the local dining scene, identify target demographics, and assess the demand for your cuisine. Market surveys reveal potential competitors, dining preferences, and pricing expectations.
• Technical Feasibility: You design the restaurant layout, plan the kitchen setup, and assess the technical requirements for equipment and facilities. You consider factors like kitchen efficiency, safety regulations, and adherence to health codes.
• Financial Feasibility: You estimate the initial costs for leasing or purchasing a space, kitchen equipment, staff hiring, and marketing. Revenue projections are based on expected foot traffic, menu pricing, and seasonal variations.
• Operational Feasibility: You create kitchen and service operations workflow diagrams, considering staff roles and responsibilities. Resource planning includes hiring chefs, waitstaff, and kitchen personnel. Scalability is evaluated for potential expansion or franchising.
• Risk Analysis: Potential operational risks are identified, such as food safety concerns, labor shortages, or location-specific challenges. Risk mitigation strategies involve staff training, quality control measures, and contingency plans for unexpected events.

Example 2: Software Development Project

Now, let's explore the feasibility study process for a software development project, such as building a mobile app:

• Market Feasibility: You analyze the mobile app market, identify your target audience, and assess the demand for a solution in a specific niche. You gather user feedback and conduct competitor analysis to understand the competitive landscape.
• Technical Feasibility: You define the technical requirements for the app, considering platforms (iOS, Android), development tools, and potential integrations with third-party services. You evaluate the feasibility of implementing specific features.
• Financial Feasibility: You estimate the development costs, including hiring developers, designers, and ongoing maintenance expenses. Revenue projections are based on app pricing, potential in-app purchases, and advertising revenue.
• Operational Feasibility: You map out the development workflow, detailing the phases from concept to deployment. Resource planning includes hiring developers with the necessary skills, setting up development environments, and establishing a testing framework.
• Risk Analysis: Potential risks like scope creep, technical challenges, or market saturation are assessed. Mitigation strategies involve setting clear project milestones, conducting thorough testing, and having contingency plans for technical glitches.

These examples demonstrate the versatility of feasibility studies across diverse projects. Whatever type of venture or endeavor you want to embark on, a well-structured feasibility study guides you toward informed decisions and increased project success.

In conclusion, conducting a feasibility study is a crucial step in your project's journey. It helps you assess the viability and potential risks, providing a solid foundation for informed decision-making. Remember, a well-executed feasibility study not only enables you to identify challenges but also uncovers opportunities that can lead to your project's success.

By thoroughly examining market trends, technical requirements, financial aspects, and operational considerations, you are better prepared to embark on your project confidently. With this guide, you've gained the knowledge and tools needed to navigate the intricate terrain of feasibility studies.

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• Open access
• Published: 31 October 2020

Guidance for conducting feasibility and pilot studies for implementation trials

• Nicole Pearson   ORCID: orcid.org/0000-0003-2677-2327 1 , 2 ,
• Patti-Jean Naylor 3 ,
• Maureen C. Ashe 5 ,
• Maria Fernandez 4 ,
• Sze Lin Yoong 1 , 2 &
• Luke Wolfenden 1 , 2  

Pilot and Feasibility Studies volume  6 , Article number:  167 ( 2020 ) Cite this article

95k Accesses

153 Citations

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Metrics details

Implementation trials aim to test the effects of implementation strategies on the adoption, integration or uptake of an evidence-based intervention within organisations or settings. Feasibility and pilot studies can assist with building and testing effective implementation strategies by helping to address uncertainties around design and methods, assessing potential implementation strategy effects and identifying potential causal mechanisms. This paper aims to provide broad guidance for the conduct of feasibility and pilot studies for implementation trials.

We convened a group with a mutual interest in the use of feasibility and pilot trials in implementation science including implementation and behavioural science experts and public health researchers. We conducted a literature review to identify existing recommendations for feasibility and pilot studies, as well as publications describing formative processes for implementation trials. In the absence of previous explicit guidance for the conduct of feasibility or pilot implementation trials specifically, we used the effectiveness-implementation hybrid trial design typology proposed by Curran and colleagues as a framework for conceptualising the application of feasibility and pilot testing of implementation interventions. We discuss and offer guidance regarding the aims, methods, design, measures, progression criteria and reporting for implementation feasibility and pilot studies.

Conclusions

This paper provides a resource for those undertaking preliminary work to enrich and inform larger scale implementation trials.

Peer Review reports

The failure to translate effective interventions for improving population and patient outcomes into policy and routine health service practice denies the community the benefits of investment in such research [ 1 ]. Improving the implementation of effective interventions has therefore been identified as a priority of health systems and research agencies internationally [ 2 , 3 , 4 , 5 , 6 ]. The increased emphasis on research translation has resulted in the rapid emergence of implementation science as a scientific discipline, with the goal of integrating effective medical and public health interventions into health care systems, policies and practice [ 1 ]. Implementation research aims to do this via the generation of new knowledge, including the evaluation of the effectiveness of implementation strategies [ 7 ]. The term “implementation strategies” is used to describe the methods or techniques (e.g. training, performance feedback, communities of practice) used to enhance the adoption, implementation and/or sustainability of evidence-based interventions (Fig. 1 ) [ 8 , 9 ].

Conceptual role of implementation strategies in improving intervention implementation and patient and public health outcomes

While there has been a rapid increase in the number of implementation trials over the past decade, the quality of trials has been criticised, and the effects of the strategies for such trials on implementation, patient or public health outcomes have been modest [ 11 , 12 , 13 ]. To improve the likelihood of impact, factors that may impede intervention implementation should be considered during intervention development and across each phase of the research translation process [ 2 ]. Feasibility and pilot studies play an important role in improving the conduct and quality of a definitive randomised controlled trial (RCT) for both intervention and implementation trials [ 10 ]. For clinical or public health interventions, pilot and feasibility studies may serve to identify potential refinements to the intervention, address uncertainties around the feasibility of intervention trial methods, or test preliminary effects of the intervention [ 10 ]. In implementation research, feasibility and pilot studies perform the same functions as those for intervention trials, however with a focus on developing or refining implementation strategies, refining research methods for an implementation intervention trial, or undertake preliminary testing of implementation strategies [ 14 , 15 ]. Despite this, reviews of implementation studies appear to suggest that few full implementation randomised controlled trials have undertaken feasibility and pilot work in advance of a larger trial [ 16 ].

A range of publications provides guidance for the conduct of feasibility and pilot studies for conventional clinical or public health efficacy trials including Guidance for Exploratory Studies of complex public health interventions [ 17 ] and the Consolidated Standards of Reporting Trials (CONSORT 2010) for Pilot and Feasibility trials [ 18 ]. However, given the differences between implementation trials and conventional clinical or public health efficacy trials, the field of implementation science has identified the need for nuanced guidance [ 14 , 15 , 16 , 19 , 20 ]. Specifically, unlike traditional feasibility and pilot studies that may include the preliminary testing of interventions on individual clinical or public health outcomes, implementation feasibility and pilot studies that explore strategies to improve intervention implementation often require assessing changes across multiple levels including individuals (e.g. service providers or clinicians) and organisational systems [ 21 ]. Due to the complexity of influencing behaviour change, the role of feasibility and pilot studies of implementation may also extend to identifying potential causal mechanisms of change and facilitate an iterative process of refining intervention strategies and optimising their impact [ 16 , 17 ]. In addition, where conventional clinical or public health efficacy trials are typically conducted under controlled conditions and directed mostly by researchers, implementation trials are more pragmatic [ 15 ]. As is the case for well conducted effectiveness trials, implementation trials often require partnerships with end-users and at times, the prioritisation of end-user needs over methods (e.g. random assignment) that seek to maximise internal validity [ 15 , 22 ]. These factors pose additional challenges for implementation researchers and underscore the need for guidance on conducting feasibility and pilot implementation studies.

Given the importance of feasibility and pilot studies in improving implementation strategies and the quality of full-scale trials of those implementation strategies, our aim is to provide practice guidance for those undertaking formative feasibility or pilot studies in the field of implementation science. Specifically, we seek to provide guidance pertaining to the three possible purposes of undertaking pilot and feasibility studies, namely (i) to inform implementation strategy development, (ii) to assess potential implementation strategy effects and (iii) to assess the feasibility of study methods.

A series of three facilitated group discussions were conducted with a group comprising of the 6 members from Canada, the U.S. and Australia (authors of the manuscript) that were mutually interested in the use of feasibility and pilot trials in implementation science. Members included international experts in implementation and behavioural science, public health and trial methods, and had considerable experience in conducting feasibility, pilot and/ or implementation trials. The group was responsible for developing the guidance document, including identification and synthesis of pertinent literature, and approving the final guidance.

To inform guidance development, a literature review was undertaken in electronic bibliographic databases and google, to identify and compile existing recommendations and guidelines for feasibility and pilot studies broadly. Through this process, we identified 30 such guidelines and recommendations relevant to our aim [ 2 , 10 , 14 , 15 , 17 , 18 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ]. In addition, seminal methods and implementation science texts recommended by the group were examined. These included the CONSORT 2010 Statement: extension to randomised pilot and feasibility trials [ 18 ], the Medical Research Council’s framework for development and evaluation of randomised controlled trials for complex interventions to improve health [ 2 ], the National Institute of Health Research (NIHR) definitions [ 39 ] and the Quality Enhancement Research Initiative (QUERI) Implementation Guide [ 4 ]. A summary of feasibility and pilot study guidelines and recommendations, and that of seminal methods and implementation science texts, was compiled by two authors. This document served as the primary discussion document in meetings of the group. Additional targeted searches of the literature were undertaken in circumstances where the identified literature did not provide sufficient guidance. The manuscript was developed iteratively over 9 months via electronic circulation and comment by the group. Any differences in views between reviewers was discussed and resolved via consensus during scheduled international video-conference calls. All members of the group supported and approved the content of the final document.

The broad guidance provided is intended to be used as supplementary resources to existing seminal feasibility and pilot study resources. We used the definitions of feasibility and pilot studies as proposed by Eldridge and colleagues [ 10 ]. These definitions propose that any type of study relating to the preparation for a main study may be classified as a “feasibility study”, and that the term “pilot” study represents a subset of feasibility studies that specifically look at a design feature proposed for the main trial, whether in part of in full, that is being conducted on a smaller scale [ 10 ]. In addition, when referring to pilot studies, unless explicitly stated otherwise, we will primarily focus on pilot trials using a randomised design. We focus on randomised trials as such designs are the most common trial design in implementation research, and randomised designs may provide the most robust estimates of the potential effect of implementation strategies [ 46 ]. Those undertaking pilot studies that employ non-randomised designs need to interpret the guidance provided in this context. We acknowledge, however, that using randomised designs can prove particularly challenging in the field of implementation science, where research is often undertaken in real-world contexts with pragmatic constraints.

We used the effectiveness-implementation hybrid trial design typology proposed by Curran and colleagues as the framework for conceptualising the application of feasibility testing of implementation interventions [ 47 ]. The typology makes an explicit distinction between the purpose and methods of implementation and conventional clinical (or public health efficacy) trials. Specifically, the first two of the three hybrid designs may be relevant for implementation feasibility or pilot studies. Hybrid Type 1 trials are those designed to test the effectiveness of an intervention on clinical or public health outcomes (primary aim) while conducting a feasibility or pilot study for future implementation via observing and gathering information regarding implementation in a real-world setting/situation (secondary aim) [ 47 ]. Hybrid Type 2 trials involve the simultaneous testing of both the clinical intervention and the testing or feasibility of a formed implementation intervention/strategy as co-primary aims. For this design, “testing” is inclusive of pilot studies with an outcome measure and related hypothesis [ 47 ]. Hybrid Type 3 trials are definitive implementation trials designed to test the effectiveness of an implementation strategy whilst also collecting secondary outcome data on clinical or public health outcomes on a population of interest [ 47 ]. As the implementation aim of the trial is a definitively powered trial, it was not considered relevant to the conduct of feasibility and pilot studies in the field and will not be discussed.

Embedding of feasibility and pilot studies within Type 1 and Type 2 effectiveness-implementation hybrid trials has been recommended as an efficient way to increase the availability of information and evidence to accelerate the field of implementation science and the development and testing of implementation strategies [ 4 ]. However, implementation feasibility and pilot studies are also undertaken as stand-alone exploratory studies and do not include effectiveness measures in terms of the patient or public health outcomes. As such, in addition to discussing feasibility and pilot trials embedded in hybrid trial designs, we will also refer to stand-alone implementation feasibility and pilot studies.

An overview of guidance (aims, design, measures, sample size and power, progression criteria and reporting) for feasibility and pilot implementation studies can be found in Table 1 .

Purpose (aims)

The primary objective of hybrid type 1 trial is to assess the effectiveness of a clinical or public health intervention (rather than an implementation strategy) on the patient or population health outcomes [ 47 ]. Implementation strategies employed in these trials are often designed to maximise the likelihood of an intervention effect [ 51 ], and may not be intended to represent the strategy that would (or could feasibly), be used to support implementation in more “real world” contexts. Specific aims of implementation feasibility or pilot studies undertaken as part of Hybrid Type 1 trials are therefore formative and descriptive as the implementation strategy has not been fully formed nor will be tested. Thus, the purpose of a Hybrid Type 1 feasibility study is generally to inform the development or refinement of the implementation strategy rather than to test potential effects or mechanisms [ 22 , 47 ]. An example of a Hybrid Type 1 trial by Cabassa and colleagues is provided in Additional file 1 [ 52 ].

In Hybrid Type 2 trial designs, there is a dual purpose to test: (i) the clinical or public health effectiveness of the intervention on clinical or public health outcomes (e.g. measure of disease or health behaviour) and (ii) test or measure the impact of the implementation strategy on implementation outcomes (e.g. adoption of health policy in a community setting) [ 53 ]. However, testing the implementation strategy on implementation outcomes may be a secondary aim in these trials and positioned as a pilot [ 22 ]. In Hybrid Type 2 trial designs, the implementation strategy is more developed than in Hybrid Type 1 trials, resembling that intended for future testing in a definitive implementation randomised controlled trial. The dual testing of the evidence-based intervention and implementation interventions or strategies in Hybrid Type 2 trial designs allows for direct assessment of potential effects of an implementation strategy and exploration of components of the strategy to further refine logic models. Additionally, such trials allow for assessments of the feasibility, utility, acceptability or quality of research methods for use in a planned definitive trial. An example of a Hybrid Type 2 trial design by Barnes and colleagues [ 54 ] is included in Additional file 2 .

Non-hybrid pilot implementation studies are undertaken in the absence of a broader effectiveness trial. Such studies typically occur when the effectiveness of a clinical or public health intervention is well established, but robust strategies to promote its broader uptake and integration into clinical or public health services remain untested [ 15 ]. In these situations, implementation pilot studies may test or explore specific trial methods for a future definitive randomised implementation trial. Similarly, a pilot implementation study may also be undertaken in a way that provides a more rigorous formative evaluation of hypothesised implementation strategy mechanisms [ 55 ], or potential impact of implementation strategies [ 56 ], using similar approaches to that employed in Hybrid Type 2 trials. Examples of potential aims for feasibility and pilot studies are outlined in Table 2 .

For implementation feasibility or pilot studies, as is the case for these types of studies in general, the selection of research design should be guided by the specific research question that the study is seeking to address [ 57 ]. Although almost any study design may be used, researchers should review the merits and potential threats to internal and external validity to help guide the selection of research design for feasibility/pilot testing [ 15 ].

As Hybrid Type 1 trials are primarily concerned with testing the effectiveness of an intervention (rather than implementation strategy), the research design will typically employ power calculations and randomisation procedures at the health outcome level to measure the effect on behaviour, symptoms, functional and/or other clinical or public health outcomes. Hybrid Type 1 feasibility studies may employ a variety of designs usually nested within the experimental group (those receiving the intervention and any form of an implementation support strategy) of the broader efficacy trial [ 47 ]. Consistent with the aims of Hybrid Type 1 feasibility and pilot studies, the research designs employed are likely to be non-comparative. Cross-sectional surveys, interviews or document review, qualitative research or mix methods approaches may be used to assess implementation contextual factors, such as barriers and enablers to implementation and/or the acceptability, perceived feasibility or utility of implementation strategies or research methods [ 47 ].

Pilot implementation studies as part of Hybrid Type 2 designs can make use of the comparative design of the broader effectiveness trial to examine the potential effects of the implementation strategy [ 47 ] and more robustly assess the implementation mechanisms, determinants and influence of broader contextual factors [ 53 ]. In this trial type, mixed method and qualitative methods may complement the findings of between group (implementation strategy arm versus comparison) quantitative comparisons, enable triangulation and provide more comprehensive evidence to inform implementation strategy development and assessment. Stand-alone implementation feasibility and pilot implementation studies are free from the constraints and opportunities of research embedded in broader effectiveness trials. As such, research can be designed in a way that best addresses the explicit implementation objectives of the study. Specifically, non-hybrid pilot studies can maximise the applicability of study findings for future definitive trials by employing methods to directly test trial methods such as recruitment or retention strategies [ 17 ], enabling estimates of implementation strategies effects [ 56 ] or capturing data to explicitly test logic models or strategy mechanisms.

The selection of outcome measures should be linked directly to the objectives of the feasibility or pilot study. Where appropriate, measures should be objective or have suitable psychometric properties, such as evidence of reliability and validity [ 58 , 59 ]. Public health evaluation frameworks often guide the choice of outcome measure in feasibility and pilot implementation work and include RE_AIM [ 60 ], PRECEDE_PROCEED [ 61 ], Proctor and colleagues framework on outcomes for implementation research [ 62 ] and more recently, the “Implementation Mapping” framework [ 63 ]. Recent work by McKay and colleagues suggests a minimum data set of implementation outcomes that includes measures of adoption, reach, dose, fidelity and sustainability [ 46 ]. We discuss selected measures below and provide a summary in Table 3 [ 46 ]. Such measures could be assessed using quantitative or qualitative or mixed methods [ 46 ].

Measures to assess potential implementation strategy effects

In addition to assessing the effects of an intervention on individual clinical or public health outcomes, Hybrid Type 2 trials (and some non-hybrid pilot studies) are interested in measures of the potential effects of an implementation strategy on desired organisational or clinician practice change such as adherence to a guideline, process, clinical standard or delivery of a program [ 62 ]. A range of potential outcomes that could be used to assess implementation strategy effects has been identified, including measures of adoption, reach, fidelity and sustainability [ 46 ]. These outcomes are described in Table 2 , including definitions and examples of how they may be applied to the implementation component of innovation being piloted. Standardised tools to assess these outcomes are often unavailable due to the unique nature of interventions being implemented and the variable (and changing) implementation context in which the research is undertaken [ 64 ]. Researchers may collect outcome data for these measures as part of environmental observations, self-completed checklists or administrative records, audio recording of client sessions or other methods suited to their study and context [ 62 ]. The limitations of such methods, however, need to be considered.

Measures to inform the design or development of the implementation strategy

Measures informing the design or development of the implementation strategy are potentially part of all types of feasibility and pilot implementation studies. An understanding of the determinants of implementation is critical to implementation strategy development. A range of theoretical determinant frameworks have been published which describe factors that may influence intervention implementation [ 65 ], and systematic reviews have been undertaken describing the psychometric properties of many of these measures [ 64 , 66 ]. McKay and colleagues have also identified a priority set of determinants for implementation trials that could be considered for use in implementation feasibility and pilot studies, including measures of context, acceptability, adaptability, feasibility, compatibility, cost, culture, dose, complexity and self-efficacy [ 46 ]. These determinants are described in Table 3 , including definitions and how such measures may be applied to an implementation feasibility or pilot study. Researchers should consider, however, the application of such measures to assess both the intervention that is being implemented (as in a conventional intervention feasibility and pilot study) and the strategy that is being employed to facilitate its implementation, given the importance of the interaction between these factors and implementation success [ 46 ]. Examples of the potential application of measures to both the intervention and its implementation strategies have been outlined elsewhere [ 46 ]. Although a range of quantitative tools could be used to measure such determinants [ 58 , 66 ], qualitative or mixed methods are generally recommended given the capacity of qualitative measures to provide depth to the interpretation of such evaluations [ 40 ].

Measures of potential implementation determinants may be included to build or enhance logic models (Hybrid Type 1 and 2 feasibility and pilot studies) and explore implementation strategy mechanisms (Hybrid Type 2 pilot studies and non-hybrid pilot studies) [ 67 ]. If exploring strategy mechanisms, a hypothesized logic model underpinning the implementation strategy should be articulated including strategy-mechanism linkages, which are required to guide the measurement of key determinants [ 55 , 63 ]. An important determinant which can complicate logic model specification and measurement is the process of adaptation—modifications to the intervention or its delivery (implementation), through the input of service providers or implementers [ 68 ]. Logic models should specify components of implementation strategies thought to be “core” to their effects and those which are thought to be “non-core” where adaptation may occur without adversely impacting on effects. Stirman and colleagues propose a method for assessing adaptations that could be considered for use in pilot and feasibility studies of implementation trials [ 69 ]. Figure 2 provides an example of some of the implementation logic model components that may be developed or refined as part of feasibility or pilot studies of implementation [ 15 , 63 ].

Example of components of an Implementation logic model

Measures to assess the feasibility of study methods

Measures of implementation feasibility and pilot study methods are similar to those of conventional studies for clinical or public health interventions. For example, standard measures of study participation and thresholds for study attrition (e.g. >20%) rates [ 73 ] can be employed in implementation studies [ 67 ]. Previous studies have also surveyed study data collectors to assess the success of blinding strategies [ 74 ]. Researchers may also consider assessing participation or adherence to implementation data collection procedures, the comprehension of survey items, data management strategies or other measures of feasibility of study methods [ 15 ].

Pilot study sample size and power

In effectiveness trials, power calculations and sample size decisions are primarily based on the detection of a clinically meaningful difference in measures of the effects of the intervention on the patient or public health outcomes such as behaviour, disease, symptomatology or functional outcomes [ 24 ]. In this context, the available study sample for implementation measures included in Hybrid Type 1 or 2 feasibility and pilot studies may be constrained by the sample and power calculations of the broader effectiveness trial in which they are embedded [ 47 ]. Nonetheless, a justification for the anticipated sample size for all implementation feasibility or pilot studies (hybrid or stand-alone) is recommended [ 18 ], to ensure that implementation measures and outcomes achieve sufficient estimates of precision to be useful. For Hybrid type 2 and relevant stand-alone implementation pilot studies, sample size calculations for implementation outcomes should seek to achieve adequate estimates of precision deemed sufficient to inform progression to a fully powered trial [ 18 ].

Progression criteria

Stating progression criteria when reporting feasibility and pilot studies is recommended as part of the CONSORT 2010 extension to randomised pilot and feasibility trials guidelines [ 18 ]. Generally, it is recommended that progression criteria should be set a priori and be specific to the feasibility measures, components and/or outcomes assessed in the study [ 18 ]. While little guidance is available, ideas around suitable progression criteria include assessment of uncertainties around feasibility, meeting recruitment targets, cost-effectiveness and refining causal hypotheses to be tested in future trials [ 17 ]. When developing progression criteria, the use of guidelines is suggested rather than strict thresholds [ 18 ], in order to allow for appropriate interpretation and exploration of potential solutions, for example, the use of a traffic light system with varying levels of acceptability [ 17 , 24 ]. For example, Thabane and colleagues recommend that, in general, the outcome of a pilot study can be one of the following: (i) stop—main study not feasible (red); (ii) continue, but modify protocol—feasible with modifications (yellow); (iii) continue without modifications, but monitor closely—feasible with close monitoring and (iv) continue without modifications (green) (44)p5.

As the goal of Hybrid Type 1 implementation component is usually formative, it may not be necessary to set additional progression criteria in terms of the implementation outcomes and measures examined. As Hybrid Type 2 trials test an intervention and can pilot an implementation strategy, criteria for these and non-hybrid pilot studies may set progression criteria based on evidence of potential effects but may also consider the feasibility of trial methods, service provider, organisational or patient (or community) acceptability, fit with organisational systems and cost-effectiveness [ 17 ]. In many instances, the progression of implementation pilot studies will often require the input and agreement of stakeholders [ 27 ]. As such, the establishment of progression criteria and the interpretation of pilot and feasibility study findings in the context of such criteria require stakeholder input [ 27 ].

Reporting suggestions

As formal reporting guidelines do not exist for hybrid trial designs, we would recommend that feasibility and pilot studies as part of hybrid designs draw upon best practice recommendations from relevant reporting standards such as the CONSORT extension for randomised pilot and feasibility trials, the Standards for Reporting Implementation Studies (STaRI) guidelines and the Template for Intervention Description and Replication (TIDieR) guide as well as any other design relevant reporting standards [ 48 , 50 , 75 ]. These, and further reporting guidelines, specific to the particular research design chosen, can be accessed as part of the EQUATOR (Enhancing the QUAility and Transparency Of health Research) network—a repository for reporting guidance [ 76 ]. In addition, researchers should specify the type of implementation feasibility or pilot study being undertaken using accepted definitions. If applicable, specification and justification behind the choice of hybrid trial design should also be stated. In line with existing recommendations for reporting of implementation trials generally, reporting on the referent of outcomes (e.g. specifying if the measure in relation to the specific intervention or the implementation strategy) [ 62 ], is also particularly pertinent when reporting hybrid trial designs.

Concerns are often raised regarding the quality of implementation trials and their capacity to contribute to the collective evidence base [ 3 ]. Although there have been many recent developments in the standardisation of guidance for implementation trials, information on the conduct of feasibility and pilot studies for implementation interventions remains limited, potentially contributing to a lack of exploratory work in this area and a limited evidence base to inform effective implementation intervention design and conduct [ 15 ]. To address this, we synthesised the existing literature and provide commentary and guidance for the conduct of implementation feasibility and pilot studies. To our knowledge, this work is the first to do so and is an important first step to the development of standardised guidelines for implementation-related feasibility and pilot studies.

Availability of data and materials

Not applicable.

Abbreviations

Randomised controlled trial

Consolidated Standards of Reporting Trials

Enhancing the QUAility and Transparency Of health Research

Standards for Reporting Implementation Studies

Strengthening the Reporting of Observational Studies in Epidemiology

Template for Intervention Description and Replication

National Institute of Health Research

Quality Enhancement Research Initiative

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Associate Professor Luke Wolfenden receives salary support from a NHMRC Career Development Fellowship (grant ID: APP1128348) and Heart Foundation Future Leader Fellowship (grant ID: 101175). Dr Sze Lin Yoong is a postdoctoral research fellow funded by the National Heart Foundation. A/Prof Maureen C. Ashe is supported by the Canada Research Chairs program.

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Example of a Hybrid Type 1 trial. Summary of publication by Cabassa et al.

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Example of a Hybrid Type 2 trial. Summary of publication by Barnes et al.

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What is a pilot or feasibility study? A review of current practice and editorial policy

• Mubashir Arain 1 ,
• Michael J Campbell 1 ,
• Cindy L Cooper 1 &
• Gillian A Lancaster 2  

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In 2004, a review of pilot studies published in seven major medical journals during 2000-01 recommended that the statistical analysis of such studies should be either mainly descriptive or focus on sample size estimation, while results from hypothesis testing must be interpreted with caution. We revisited these journals to see whether the subsequent recommendations have changed the practice of reporting pilot studies. We also conducted a survey to identify the methodological components in registered research studies which are described as 'pilot' or 'feasibility' studies. We extended this survey to grant-awarding bodies and editors of medical journals to discover their policies regarding the function and reporting of pilot studies.

Papers from 2007-08 in seven medical journals were screened to retrieve published pilot studies. Reports of registered and completed studies on the UK Clinical Research Network (UKCRN) Portfolio database were retrieved and scrutinized. Guidance on the conduct and reporting of pilot studies was retrieved from the websites of three grant giving bodies and seven journal editors were canvassed.

54 pilot or feasibility studies published in 2007-8 were found, of which 26 (48%) were pilot studies of interventions and the remainder feasibility studies. The majority incorporated hypothesis-testing (81%), a control arm (69%) and a randomization procedure (62%). Most (81%) pointed towards the need for further research. Only 8 out of 90 pilot studies identified by the earlier review led to subsequent main studies. Twelve studies which were interventional pilot/feasibility studies and which included testing of some component of the research process were identified through the UKCRN Portfolio database. There was no clear distinction in use of the terms 'pilot' and 'feasibility'. Five journal editors replied to our entreaty. In general they were loathe to publish studies described as 'pilot'.

Pilot studies are still poorly reported, with inappropriate emphasis on hypothesis-testing. Authors should be aware of the different requirements of pilot studies, feasibility studies and main studies and report them appropriately. Authors should be explicit as to the purpose of a pilot study. The definitions of feasibility and pilot studies vary and we make proposals here to clarify terminology.

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A brief definition is that a pilot study is a 'small study for helping to design a further confirmatory study'[ 1 ]. A very useful discussion of exactly what is a pilot study has been given by Thabane et al. [ 2 ] Such kinds of study may have various purposes such as testing study procedures, validity of tools, estimation of the recruitment rate, and estimation of parameters such as the variance of the outcome variable to calculate sample size etc. In pharmacological trials they may be referred to as 'proof of concept' or Phase I or Phase II studies. It has become apparent to us when reviewing research proposals that small studies with all the trappings of a major study, such as randomization and hypothesis testing may be labeled a 'pilot' because they do not have the power to test clinically meaningful hypotheses. The authors of such studies perhaps hope that reviewers will regard a 'pilot' more favourably than a small clinical trial. This lead us to ask when it is legitimate to label a study as a 'pilot' or 'feasibility' study, and what features should be included in these types of studies.

Lancaster et al [ 3 ] conducted a review of seven major medical journals in 2000-1 to produce evidence regarding the components of pilot studies for randomized controlled trials. Their search included both 'pilot' and 'feasibility' studies as keywords. They reported certain recommendations: having clear objectives in a pilot study, inappropriateness of mixing pilot data with main research study, using mainly descriptive statistics obtained and caution regarding the use of hypothesis testing for conclusions. Arnold et al [ 1 ] recently reviewed pilot studies particularly related to critical care medicine by searching the literature from 1997 to 2007. They provided narrative descriptions of some pilot papers particularly those describing critical care medicine procedures. They pointed out that few pilot trials later evolved into subsequent published major trials. They made useful distinctions between: pilot work which is any background research to inform a future study, a pilot study which has specific hypotheses, objectives and methodology and a pilot trial which is a stand-alone pilot study and includes a randomization procedure. They excluded feasibility studies from their consideration.

Thabane et al [ 2 ] gave a checklist of what they think should be included in a pilot study. They included 'feasibility' or 'vanguard' studies but did not distinguish them from pilot studies. They provided a good discussion on how to interpret a pilot study. They stress that not only the outcome or surrogate outcome for the subsequent main study should be described but also that a pilot study should have feasibility outcomes which should be clearly defined and described. Their article was opinion based and not supported by a review of current practice.

The objective of this paper is to provide writers and reviewers of research proposals with evidence from a variety of sources for which components they should expect, and which are unnecessary or unhelpful, in a study which is labeled as a pilot or feasibility study. To do this we repeated Lancaster et al's [ 3 ] review for current papers see if there has been any change in how pilot studies were reported since their study. As many pilot studies are never published we also identified pilot studies which were registered with the UK Clinical Research Network (UKCRN) Portfolio Database. This aims to be a "complete picture of the clinical research which is currently taking place across the UK". All studies included have to have been peer reviewed through a formal independent process. We examined the websites of some grant giving bodies to find their definition of a pilot study and their funding policy toward them. Finally we contacted editors of leading medical journals to discover their policy of accepting studies described as 'pilot' or 'feasibility'.

Literature survey

MEDLINE, Web of Science and university library data bases were searched for the years 2007-8 using the same key words "Pilot" or "Feasibility" as used by Lancaster et al. [ 3 ]. We reviewed the same four general medicine journals: the British Medical Journal (BMJ), Lancet, the New England Journal of Medicine (NEJM) and the Journal of American Medical Association (JAMA) and the same three specialist journals: British Journal of Surgery (BJS), British Journal of Cancer (BJC), British Journal of Obstetrics and Gynecology (BJOG). We excluded review papers. The full text of the relevant papers was obtained. GL reviewed 20 papers and classified them into groups as described in her original paper [ 3 ]. Subsequently MA, in discussion with MC, designed a data extraction form to classify the papers. We changed one category from GL's original paper. We separated the category 'Phase I/II trials' from the 'Piloting new treatment, technique, combination of treatments' category. We then classified the remaining paper into the categories described in Table 1 . The total number of research papers by journal was obtained by searching journal article with abstracts (excluding reviews) using Pubmed. We searched citations to see whether the pilot studies identified by Lancaster et al [ 3 ] eventually led to main trials.

Portfolio database review

The (UKCRN) Portfolio Database was searched for the terms 'feasibility' or 'pilot' in the title or research summary. Duplicate cases and studies classified as 'observational' were omitted. From the remaining studies those classified as 'closed' were selected to exclude studies which may not have started or progressed. Data were extracted directly from the research summary of the database or where that was insufficient the principle investigator was contacted for related publications or study protocols.

Editor and funding agency survey

We wrote to the seven medical journal editors of the same journals used by Lancaster et al. [ 3 ], (BMJ, Lancet, NEJM, JAMA. BJS, BJC and BJOG) and looked at the policies of three funding agencies (British Medical Research Council, Research for Patient Benefit and NETSCC (National Institute for Health Research Trials and Studies Coordinating Centre). We wished to explore whether there was any specified policy of the journal for publishing pilot trials and how the editors defined a pilot study. We also wished to see if there was funding for pilot studies.

Initially 77 papers were found in the target journals for 2007-8 but 23 were review papers or commentaries or indirectly referred to the word "pilot" or "feasibility" and were not actually pilot studies leaving a total of 54 papers. Table 1 shows the results by journal and by type of study and also shows the numbers reported by Lancaster et al. [ 3 ] for 2000-01 in the same medical journals. There was a decrease in the proportion of pilot studies published over the period of time, however the difference was not statistically significant (2.0% vs 1.6%; X 2 = 1.6, P = 0.2). It is noticeable that the Phase I or Phase II studies are largely confined to the cancer journals.

Lancaster et al [ 3 ] found that 50% of pilot studies reported the intention of further work yet we identified only 8 (8.8%) which were followed up by a major study. Of these 2 (25%) were published in the same journal as the pilot.

Twenty-six of the studies found in 2007-8 were described as pilot or feasibility studies for randomized clinical trials (RCTs) including Phase II studies. Table 2 gives the numbers of studies which describe specific components of RCTs. Sample size calculations were performed and reported in 9 (36%) of the studies. Hypothesis testing and performing inferential statistics to report significant results was observed in 21 (81%) of pilot studies. The processes of blinding was observed in only 5 (20%) although the randomization procedure was applied or tested in 16 (62%) studies. Similarly a control group was assigned in most of the studies (n = 18; 69%). As many as 21 (81%) of pilot studies suggested the need for further investigation of the tested drug or procedure and did not report conclusive results on the basis of their pilot data. The median number of participants was 76, inter-quartile range (42, 216).

Of the 54 studies in 2007-8, a total of 20 were described as 'pilot' and 34 were described as 'feasibility' studies. Table 3 contrasts those which were identified by the keyword 'pilot' with those identified by 'feasibility'. Those using 'pilot' were more likely to have a pre-study sample size estimate, to use randomization and to use a control group. In the 'pilot' group 16(80%) suggested further study, in contrast to 15 (44%) in the 'feasibility' group.

A total of 34 studies were identified using the term 'feasibility' or 'pilot' in the title or research summary which were prospective interventional studies and were closed, i.e. not currently running and available for analysis. Only 12 studies were interventional pilot/feasibility studies which included testing of some component of the research process. Of these 5 were referred to as 'feasibility', 6 as 'pilot' and 1 as both 'feasibility' and 'pilot' (Table 4 ).

The methodological components tested within these studies were: estimation of sample size; number of subjects eligible; resources (e.g. cost), time scale; population-related (e.g. exclusion criteria), randomisation process/acceptability; data collection systems/forms; outcome measures; follow-up (response rates, adherence); overall design; whole trial feasibility. In addition to one or more of these, some studies also looked at clinical outcomes including: feasibility/acceptability of intervention; dose, efficacy and safety of intervention.

The results are shown in Table 4 . Pilot studies alone included estimation of sample size for a future bigger study and tested a greater number of components in each study. The majority of the pilots and the feasibility studies ran the whole study 'in miniature' as it would be in the full study, with or without randomization.

As an example of a pilot study consider 'CHOICES: A pilot patient preference randomised controlled trial of admission to a Women's Crisis House compared with psychiatric hospital admissions' http://www.iop.kcl.ac.uk/projects/default.aspx?id=10290 . This study looked at multiple components of a potential bigger study. It aimed to determine the proportion of women unwilling to be randomised, the feasibility of a patient preference RCT design, the outcome and cost measures to determine which outcome measures to use, the recruitment and drop out rates; and to estimate the levels of outcome variability to calculate sample sizes for the main study. It also intended to develop a user focused and designed instrument which is the outcome from the study. The sample size was 70.

The editors of five (out of seven) medical journals responded to our request for information regarding publishing policy for pilot studies. Four of the journals did not have a specified policy about publishing pilot studies and mostly reported that pilot trials cannot be published if the standard is lower than a full clinical trial requirement. The Lancet has started creating space for preliminary phase I trials and set a different standard for preliminary studies. Most of the other journals do not encourage the publication of pilot studies because they consider them less rigorous than main studies. Nevertheless some editors accepted pilot studies for publication by compromising only on the requirement for a pre-study sample size calculation. All other methodological issued were considered as important as for the full trials, such as trial registration, randomization, hypothesis testing, statistical analysis and reporting according to the CONSORT guidelines.

All three funding bodies made a point to note that pilot and feasibility studies would be considered for funding. Thabane et al [ 2 ] provided a list of websites which define pilot or feasibility studies. We considered the NETSCC definition to be most helpful and to most closely mirror what investigators are doing and it is given below.

NETSCC definition of pilot and feasibility studies http://www.netscc.ac.uk/glossary/

Feasibility Studies

Feasibility Studies are pieces of research done before a main study. They are used to estimate important parameters that are needed to design the main study. For instance:

standard deviation of the outcome measure, which is needed in some cases to estimate sample size,

willingness of participants to be randomised,

willingness of clinicians to recruit participants,

number of eligible patients,

characteristics of the proposed outcome measure and in some cases feasibility studies might involve designing a suitable outcome measure,

follow-up rates, response rates to questionnaires, adherence/compliance rates, ICCs in cluster trials, etc.

Feasibility studies for randomised controlled trials may not themselves be randomised. Crucially, feasibility studies do not evaluate the outcome of interest; that is left to the main study.

If a feasibility study is a small randomised controlled trial, it need not have a primary outcome and the usual sort of power calculation is not normally undertaken. Instead the sample size should be adequate to estimate the critical parameters (e.g. recruitment rate) to the necessary degree of precision.

Pilot studies

A Pilot Study is a version of the main study that is run in miniature to test whether the components of the main study can all work together. It is focused on the processes of the main study, for example to ensure recruitment, randomisation, treatment, and follow-up assessments all run smoothly. It will therefore resemble the main study in many respects. In some cases this will be the first phase of the substantive study and data from the pilot phase may contribute to the final analysis; this can be referred to as an internal pilot. Alternatively at the end of the pilot study the data may be analysed and set aside, a so-called external pilot.

In our repeat of Lancaster et al's study [ 3 ] we found that the reporting of pilot studies was still poor. It is generally accepted that small, underpowered clinical trials are unethical [ 4 ]. Thus it is not an excuse to label such a study as a pilot and hope to make it ethical. We have shown that pilot studies have different objectives to RCTs and these should be clearly described. Participants in such studies should be informed that they are in a pilot study and that there may not be a further larger study.

It is helpful to make a more formal distinction between a 'pilot' and a 'feasibility' study. We found that studies labeled 'feasibility' were conducted with more flexible methodology compared to those labeled 'pilot'. For example the term 'feasibility' has been used for large scale studies such as a screening programme applied at a population level to determine the initial feasibility of the programme. On the other hand 'pilot' studies were reported with more rigorous methodological components like sample size estimation, randomization and control group selection than studies labeled 'feasibility'. We found the NETSCC definition to be the most helpful since it distinguishes between these types of study.

In addition it was observed that most of the pilot studies report their results as inconclusive, with the intention of conducting a further, larger study. In contrast, several of the feasibility studies did not admit such an intention. On the basis of their intention one would have expected about 45 of the studies identified by Lancaster et al in 2000/1 to have been followed by a bigger study whereas we only found 8. This would reflect the opinion of most of the journal editors and experts who responded to our survey, who felt that pilot studies rarely act as a precursor for a bigger study. The main reason given was that if the pilot shows significant results then researchers may not find it necessary to conduct the main trial. In addition if the results are unfavorable or the authors find an unfeasible procedure, the main study is less likely to be considered useful. Our limited review of funding bodies was encouraging. Certainly when reviewing grant applications, we have found it helpful to have the results of a pilot study included in the bid. We think that authors of pilots studies should be explicit as to their purpose, e.g. to test a new procedure in preparation for a clinical trial. We also think that authors of proposals for pilot studies should be more explicit as to the criteria which lead to further studies being abandoned, and that this should be an important part of the proposal.

In the Portfolio Database review, only pilot studies cited an intention to estimate sample size calculations for future studies and the majority of pilot studies were full studies run with smaller sample sizes to test out a number of methodological components and clinical outcomes simultaneously. In comparison the feasibility studies tended to focus on fewer methodological components within individual studies. For example, the 6 pilot studies reported the intention to evaluate a total of 17 methodological components whereas in the 5 feasibility studies a total of only 6 methodological components were specifically identified as being under investigation (Table 4 ). However, both pilot and feasibility studies included trials run as complete studies, including randomization, but with sample sizes smaller than would be intended in the full study and the distinction between the two terms was not clear-cut.

Another reason for conducting a pilot study is to provide information to enable a sample size calculation in a subsequent main study. However since pilot studies tend to be small, the results should be interpreted with caution [ 5 ]. Only a small proportion of published pilot studies reported pre-study sample size calculations. Most journal editors reported that a sample size calculation is not a mandatory criterion for publishing pilot studies and suggested that it should not be done.

Some authors suggest that analysis of pilot studies should mainly be descriptive,[ 3 , 6 ] as hypothesis testing requires a powered sample size which is usually not available in pilot studies. In addition, inferential statistics and testing hypothesis for effectiveness require a control arm which may not be present in all pilot studies. However most of the pilot interventional studies in this review contained a control group and the authors performed and reported hypothesis testing for one or more variables. Some tested the effectiveness of an intervention and others just performed statistical testing to discover any important associations in the study variables. Observed practice is not necessarily good practice and we concur with Thabane et al [ 2 ] that any testing of an intervention needs to be reported cautiously.

The views of the journal editors, albeit from a small sample, were not particularly encouraging and reflected the experience of Lancaster et al [ 3 ]. Pilot studies, by their nature, will not produce 'significant' (i.e P < 0.05) results. We believe that publishing the results of well conducted pilot or feasibility studies is important for research, irrespective of outcome.. There is an increasing awareness that publishing only 'significant' results can lead to considerably error [ 7 ]. The journals we considered were all established, paper journals and perhaps the newer electronic journals will be more willing to consider the publication of the results from these types of studies.

We may expect that trials will increasingly be used to evaluate 'complex interventions'[ 8 , 9 ]. The MRC guidelines [ 8 ] explicitly suggest that preliminary studies, including pilots, be used prior to any major trial which seeks to evaluate a package of interventions (such as an educational course), rather than a single intervention (such as a drug). Thus it is likely that reviewers will be increasingly asked to pronounce on these and will require guidance as to how to review them.

Conclusions

We conclude that pilot studies are still poorly reported, with inappropriate emphasis on hypothesis-testing. We believe authors should be aware of the different requirements of pilot studies and feasibility studies and report them appropriately. We found that in practice the definitions of feasibility and pilot studies are not distinct and vary between health research funding bodies and we suggest use of the NETSCC definition to clarify terminology.

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MA reviewed the papers of 2000/1 and those of 2007/8 under the supervision of MC and helped to draft the manuscript. MC conceived of the study, and participated in its design and coordination and drafted the manuscript. CC conducted the portfolio database study and commented on the manuscript. GA conducted the original study, reviewed 20 papers and commented on the manuscript. All authors read and approved the final manuscript.

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Arain, M., Campbell, M.J., Cooper, C.L. et al. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol 10 , 67 (2010). https://doi.org/10.1186/1471-2288-10-67

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What Is a Feasibility Study?

Understanding a feasibility study, how to conduct a feasibility study, the bottom line.

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Feasibility Study

Investopedia contributors come from a range of backgrounds, and over 25 years there have been thousands of expert writers and editors who have contributed.

Yarilet Perez is an experienced multimedia journalist and fact-checker with a Master of Science in Journalism. She has worked in multiple cities covering breaking news, politics, education, and more. Her expertise is in personal finance and investing, and real estate.

A feasibility study is a detailed analysis that considers all of the critical aspects of a proposed project in order to determine the likelihood of it succeeding.

Success in business may be defined primarily by return on investment , meaning that the project will generate enough profit to justify the investment. However, many other important factors may be identified on the plus or minus side, such as community reaction and environmental impact.

Although feasibility studies can help project managers determine the risk and return of pursuing a plan of action, several steps should be considered before moving forward.

Key Takeaways

• A company may conduct a feasibility study when it’s considering launching a new business, adding a new product line, or acquiring a rival.
• A feasibility study assesses the potential for success of the proposed plan or project by defining its expected costs and projected benefits in detail.
• It’s a good idea to have a contingency plan on hand in case the original project is found to be infeasible.

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A feasibility study is an assessment of the practicality of a proposed plan or project. A feasibility study analyzes the viability of a project to determine whether the project or venture is likely to succeed. The study is also designed to identify potential issues and problems that could arise while pursuing the project.

As part of the feasibility study, project managers must determine whether they have enough of the right people, financial resources, and technology. The study must also determine the return on investment, whether this is measured as a financial gain or a benefit to society, the latter in the case of a nonprofit project.

The feasibility study might include a cash flow analysis, measuring the level of cash generated from revenue vs. the project’s operating costs . A risk assessment must also be completed to determine whether the return is enough to offset the risk of undergoing the venture.

When doing a feasibility study, it’s always good to have a contingency plan that is ready to test as a viable alternative if the first plan fails.

Benefits of a Feasibility Study

There are several benefits to feasibility studies, including helping project managers discern the pros and cons of undertaking a project before investing a significant amount of time and capital into it.

Feasibility studies can also provide a company’s management team with crucial information that could prevent them from entering into a risky business venture.

Such studies help companies determine how they will grow. They will know more about how they will operate, what the potential obstacles are, who the competition is, and what the market is.

Feasibility studies also help convince investors and bankers that investing in a particular project or business is a wise choice.

The exact format of a feasibility study will depend on the type of organization that requires it. However, the same factors will be involved even if their weighting varies.

Preliminary Analysis

Although each project can have unique goals and needs, there are some best practices for conducting any feasibility study:

• Conduct a preliminary analysis, which involves getting feedback about the new concept from the appropriate stakeholders.
• Analyze and ask questions about the data obtained in the early phase of the study to make sure that it’s solid.
• Conduct a market survey or market research to identify the market demand and opportunity for pursuing the project or business.
• Write an organizational, operational, or business plan, including identifying the amount of labor needed, at what cost, and for how long.
• Prepare a projected income statement, which includes revenue, operating costs, and profit .
• Prepare an opening day balance sheet .
• Identify obstacles and any potential vulnerabilities, as well as how to deal with them.
• Make an initial “go” or “no-go” decision about moving ahead with the plan.

Suggested Components

Once the initial due diligence has been completed, the real work begins. Components that are typically found in a feasibility study include the following:

• Executive summary : Formulate a narrative describing details of the project, product, service, plan, or business.
• Technological considerations : Ask what will it take. Do you have it? If not, can you get it? What will it cost?
• Existing marketplace : Examine the local and broader markets for the product, service, plan, or business.
• Marketing strategy : Describe it in detail.
• Required staffing : What are the human capital needs for this project? Draw up an organizational chart.
• Schedule and timeline : Include significant interim markers for the project’s completion date.
• Project financials
• Findings and recommendations : Break down into subsets of technology, marketing, organization, and financials.

Examples of a Feasibility Study

Below are two examples of a feasibility study. The first involves expansion plans for a university. The second is a real-world example conducted by the Washington State Department of Transportation with private contributions from Microsoft Inc.

A University Science Building

Officials at a university were concerned that the science building—built in the 1970s—was outdated. Considering the technological and scientific advances of the last 20 years, they wanted to explore the cost and benefits of upgrading and expanding the building. A feasibility study was conducted.

In the preliminary analysis, school officials explored several options, weighing the benefits and costs of expanding and updating the science building. Some school officials had concerns about the project, including the cost and possible community opposition. The new science building would be much larger, and the community board had earlier rejected similar proposals. The feasibility study would need to address these concerns and any potential legal or zoning issues.

The feasibility study also explored the technological needs of the new science facility, the benefits to the students, and the long-term viability of the college. A modernized science facility would expand the school’s scientific research capabilities, improve its curriculum, and attract new students.

Financial projections showed the cost and scope of the project and how the school planned to raise the needed funds, which included issuing a bond to investors and tapping into the school’s endowment . The projections also showed how the expanded facility would allow more students to be enrolled in the science programs, increasing revenue from tuition and fees.

The feasibility study demonstrated that the project was viable, paving the way to enacting the modernization and expansion plans of the science building.

Without conducting a feasibility study, the school administrators would never have known whether its expansion plans were viable.

A High-Speed Rail Project

The Washington State Department of Transportation decided to conduct a feasibility study on a proposal to construct a high-speed rail that would connect Vancouver, British Columbia, Seattle, Washington, and Portland, Oregon. The goal was to create an environmentally responsible transportation system to enhance the competitiveness and future prosperity of the Pacific Northwest.

The preliminary analysis outlined a governance framework for future decision making. The study involved researching the most effective governance framework by interviewing experts and stakeholders, reviewing governance structures, and learning from existing high-speed rail projects in North America. As a result, governing and coordinating entities were developed to oversee and follow the project if it was approved by the state legislature.

A strategic engagement plan involved an equitable approach with the public, elected officials, federal agencies, business leaders, advocacy groups, and Indigenous communities. The engagement plan was designed to be flexible, considering the size and scope of the project and how many cities and towns would be involved. A team of the executive committee members was formed and met to discuss strategies, as well as lessons learned from previous projects, and met with experts to create an outreach framework.

The financial component of the feasibility study outlined the strategy for securing the project’s funding, which explored obtaining funds from federal, state, and private investments. The project’s cost was estimated to be $24 billion to $42 billion. The revenue generated from the high-speed rail system was estimated to be $160 million to $250 million.

The report bifurcated the money sources between funding and financing. Funding referred to grants, appropriations from the local or state government, and revenue. Financing referred to bonds issued by the government, loans from financial institutions, and equity investments, which are essentially loans against future revenue that need to be paid back with interest.

The sources for the capital needed were to vary as the project moved forward. In the early stages, most of the funding would come from the government, and as the project developed, funding would come from private contributions and financing measures. Private contributors included Microsoft Inc.

The benefits outlined in the feasibility report show that the region would experience enhanced interconnectivity, allowing for better management of the population and increasing regional economic growth by $355 billion. The new transportation system would provide people with access to better jobs and more affordable housing. The high-speed rail system would also relieve congested areas from automobile traffic.

The timeline for the study began in 2016, when an agreement was reached with British Columbia to work together on a new technology corridor that included high-speed rail transportation. The feasibility report was submitted to the Washington State Legislature in December 2020.

What Is the Main Objective of a Feasibility Study?

A feasibility study is designed to help decision makers determine whether or not a proposed project or investment is likely to be successful. It identifies both the known costs and the expected benefits.

In business, “successful” means that the financial return exceeds the cost. In a nonprofit, success may be measured in other ways. A project’s benefit to the community it serves may be worth the cost.

What Are the Steps in a Feasibility Study?

A feasibility study starts with a preliminary analysis. Stakeholders are interviewed, market research is conducted, and a business plan is prepared. All of this information is analyzed to make an initial “go” or “no-go” decision.

If it’s a go, the real study can begin. This includes listing the technological considerations, studying the marketplace, describing the marketing strategy, and outlining the necessary human capital, project schedule, and financing requirements.

Who Conducts a Feasibility Study?

A feasibility study may be conducted by a team of the organization’s senior managers. If they lack the expertise or time to do the work internally, it may be outsourced to a consultant.

What Are the 4 Types of Feasibility?

The study considers the feasibility of four aspects of a project:

Technical : A list of the hardware and software needed, and the skilled labor required to make them work

Financial : An estimate of the cost of the overall project and its expected return

Market : An analysis of the market for the product or service, the industry, competition, consumer demand, sales forecasts, and growth projections

Organizational : An outline of the business structure and the management team that will be needed

Feasibility studies help project managers determine the viability of a project or business venture by identifying the factors that can lead to its success. The study also shows the potential return on investment and any risks to the success of the venture.

A feasibility study contains a detailed analysis of what’s needed to complete the proposed project. The report may include a description of the new product or venture, a market analysis, the technology and labor needed, and the sources of financing and capital. The report will also include financial projections, the likelihood of success, and ultimately, a “go” or “no-go” decision.

Washington State Department of Transportation. “ Ultra-High-Speed Rail Study .”

Washington State Department of Transportation. “ Cascadia Ultra High Speed Ground Transportation: Framework for the Future .”

Washington State Department of Transportation. “ Ultra-High-Speed Rail Study: Outcomes .”

Washington State Department of Transportation. “ Ultra-High-Speed Ground Transportation Business Case Analysis ,” Page ii (Page 3 of PDF).

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• Number 5 / September 2018

Feasibility Studies: What They Are, How They Are Done, and What We Can Learn From Them

Anne M. Kolenic

Nursing clinical research is a growing field, and as more nurses become engaged in conducting clinical research, feasibility studies may be their first encounter. Understanding what they are, how to conduct them, and the importance of properly reporting their outcomes is vital to the continued advancement of nursing science.

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Feasibility Studies: What They Are, How They Are Done, and What We Can Learn From Them

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• 1 University Hospitals Seidman Cancer Center.
• PMID: 30118444
• DOI: 10.1188/18.ONF.572-574

Nursing clinical research is a growing field, and as more nurses become engaged in conducting clinical research, feasibility studies may be their first encounter. Understanding what they are, how to conduct them, and the importance of properly reporting their outcomes is vital to the continued advancement of nursing science.

Keywords: clinical research; evidence-based practice; feasibility studies; nursing science.

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• [Evaluation nursing research in nursing practice. III. Process of conducting evaluation research. 9. Three column approach to generating researchable problems]. Lindeman CA. Lindeman CA. Kango Kenkyu. 1989 Spring;22(1):42-51. Kango Kenkyu. 1989. PMID: 2927012 Japanese. No abstract available.
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How to conduct a feasibility study: Templates and examples

Conducting a feasibility study is an important step in successful project management. By evaluating the viability of a proposed project, a feasibility study helps you identify potential challenges and opportunities, ensuring you make informed decisions. In this guide, we’ll walk you through how to conduct a feasibility study with practical templates and real-world examples, designed for project managers seeking to optimize their project planning process.

It can be exciting to run a large, complex project that has a huge potential impact on your organization. On the one hand, you’re driving real change. On the other hand, failure is intimidating. 

What is a feasibility study? 

A feasibility study—sometimes called a feasibility analysis or feasibility report—is a way to evaluate whether or not a project plan could be successful. A feasibility study evaluates the practicality of your project plan in order to judge whether or not you’re able to move forward with the project. 

It does so by answering two questions: 

Does our team have the required tools or resources to complete this project? 

Will there be a high enough return on investment to make the project worth pursuing? 

Benefits of conducting a feasibility study

There are several key benefits to conducting a feasibility study before launching a new project:

Confirms market opportunities and the target market before investing significant resources

Identifies potential issues and risks early on

Provides in-depth data for better decision making on the proposed project's viability

Creates documentation on expected costs and benefits, including financial analysis

Obtains stakeholder buy-in by demonstrating due diligence

Feasibility studies are important for projects that represent significant investments for your business. Projects that also have a large potential impact on your presence in the market may also require a feasibility assessment. 

As the project manager , you may not be directly responsible for driving the feasibility study, but it’s important to know what these studies are. By understanding the different elements that go into a feasibility study, you can better support the team driving the feasibility study and ensure the best outcome for your project.

When should you conduct a feasibility analysis?

A feasibility study should be conducted after the project has been pitched but before any work has actually started. The study is part of the project planning process. In fact, it’s often done in conjunction with a SWOT analysis or project risk assessment , depending on the specific project. 

Feasibility studies help: 

Confirm market opportunities before committing to a project

Narrow your business alternatives

Create documentation about the benefits and disadvantages of your proposed initiative

Provide more information before making a go-or-no-go decision

You likely don’t need a feasibility study if:

You already know the project is feasible

You’ve run a similar project in the past

Your competitors are succeeding with a similar initiative in market

The project is small, straightforward, and has minimal long-term business impact

Your team ran a similar feasibility analysis within the past three years

One thing to keep in mind is that a feasibility study is not a project pitch. During a project pitch, you’re evaluating whether or not the project is a good idea for your company and whether the goals of the project are in line with your overall strategic plan. Typically, once you’ve established that the project is a good idea, you'll run a feasibility study to confirm that the project is possible with the tools and resources you have at your disposal. 

Types of feasibility studies

There are five main types of feasibility studies: technical feasibility, financial feasibility, market feasibility (or market fit), operational feasibility, and legal feasibility. Most comprehensive feasibility studies will include an assessment of all five of these areas.

Technical feasibility

A technical feasibility study reviews the technical resources available for your project. This study determines if you have the right equipment, enough equipment, and the right technical knowledge to complete your project objectives . For example, if your project plan proposes creating 50,000 products per month, but you can only produce 30,000 products per month in your factories, this project isn’t technically feasible. 

Financial feasibility

Financial feasibility describes whether or not your project is fiscally viable. A financial feasibility report includes a cost-benefit analysis of the project. It also forecasts an expected return on investment (ROI) and outlines any financial risks. The goal at the end of the financial feasibility study is to understand the economic benefits the project will drive. 

Market feasibility

The market feasibility study is an evaluation of how your team expects the project’s deliverables to perform in the market. This part of the report includes a market analysis, a market competition breakdown, and sales projections.

Operational feasibility

An operational feasibility study evaluates whether or not your organization is able to complete this project. This includes staffing requirements, organizational structure, and any applicable legal requirements. At the end of the operational feasibility study, your team will have a sense of whether or not you have the resources, skills, and competencies to complete this work. 

Legal feasibility

A legal feasibility analysis assesses whether the proposed project complies with all relevant legal requirements and regulations. This includes examining legal and regulatory barriers, necessary permits, licenses, or certifications, potential legal liabilities or risks, and intellectual property considerations. The legal feasibility study ensures that the project can be completed without running afoul of any laws or incurring undue legal exposure for the organization.

Feasibility assessment checklist

Most feasibility studies are structured in a similar way. These documents serve as an assessment of the practicality of a proposed business idea. Creating a clear feasibility study helps project stakeholders during the decision making process. 

The essential elements of a feasibility study are: 

An executive summary describing the project’s overall viability

A description of the product or service being developed during this project

Any technical considerations , including technology, equipment, or staffing

The market survey , including a study of the current market and the marketing strategy 

The operational feasibility study evaluates whether or not your team’s current organizational structure can support this initiative

The project timeline

Financial projections based on your financial feasibility report

6 steps to conduct a feasibility study

You likely won’t be conducting the feasibility study yourself, but you will probably be called on to provide insight and information. To conduct a feasibility study, hire a trained consultant or, if you have an in-house project management office (PMO) , ask if they take on this type of work. In general, here are the steps they’ll take to complete this work: 

1. Run a preliminary analysis

Creating a feasibility study is a time-intensive process. Before diving into the feasibility study, it’s important to evaluate the project for any obvious and insurmountable roadblocks. For example, if the project requires significantly more budget than your organization has available, you likely won’t be able to complete it. Similarly, if the project deliverables need to be live and in the market by a certain date but won’t be available for several months after that, the project likely isn’t feasible either. These types of large-scale obstacles make a feasibility study unnecessary because it’s clear the project is not viable.

2. Evaluate financial feasibility

Think of the financial feasibility study as the projected income statement for the project. This part of the feasibility study clarifies the expected project income and outlines what your organization needs to invest—in terms of time and money—in order to hit the project objectives. 

During the financial feasibility study, take into account whether or not the project will impact your business's cash flow. Depending on the complexity of the initiative, your internal PMO or external consultant may want to work with your financial team to run a cost-benefit analysis of the project. 

3. Run a market assessment

The market assessment, or market feasibility study, is a chance to identify the demand in the market. This study offers a sense of expected revenue for the project and any potential market risks you could run into. 

The market assessment, more than any other part of the feasibility study, is a chance to evaluate whether or not there’s an opportunity in the market. During this study, it’s critical to evaluate your competitor’s positions and analyze demographics to get a sense of how the project will go. 

4. Consider technical and operational feasibility

Even if the financials are looking good and the market is ready, this initiative may not be something your organization can support. To evaluate operational feasibility, consider any staffing or equipment requirements this project needs. What organizational resources—including time, money, and skills—are necessary in order for this project to succeed? 

Depending on the project, it may also be necessary to consider the legal impact of the initiative. For example, if the project involves developing a new patent for your product, you will need to involve your legal team and incorporate that requirement into the project plan.

5. Review project points of vulnerability

At this stage, your internal PMO team or external consultant have looked at all four elements of your feasibility study—financials, market analysis, technical feasibility, and operational feasibility. Before running their recommendations by you and your stakeholders, they will review and analyze the data for any inconsistencies. This includes ensuring the income statement is in line with your market analysis. Similarly, now that they’ve run a technical feasibility study, are any liabilities too big of a red flag? (If so, create a contingency plan !) 

Depending on the complexity of your project, there won’t always be a clear answer. A feasibility analysis doesn’t provide a black-and-white decision for a complex problem. Rather, it helps you come to the table with the right questions—and answers—so you can make the best decision for your project and for your team.

6. Propose a decision

The final step of the feasibility study is an executive summary touching on the main points and proposing a solution. 

Depending on the complexity and scope of the project, your internal PMO or external consultant may share the feasibility study with stakeholders or present it to the group in order to field any questions live. Either way, with the study in hand, your team now has the information you need to make an informed decision.

Feasibility study examples

To better understand the concepts behind feasibility assessments, here are two hypothetical examples demonstrating how these studies can be applied in real-world scenarios.

Example 1: New product development

A consumer goods company is considering launching a new product line. Before investing in new product development, they conduct a feasibility study to assess the proposed project.

The feasibility study includes:

Market research to gauge consumer interest, assess competitor offerings, and estimate potential market share for the target market.

Technological considerations, including R&D requirements, production processes, and any necessary patents or certifications.

In-depth financial analysis projects sales volumes, revenue, costs, and profitability over a multi-year period.

Evaluation of organizational readiness, including the skills of the current management team and staff to bring the new product to market.

Assessment of legal feasibility to ensure compliance with regulations and identify any potential liability issues.

The comprehensive feasibility study identifies a promising market opportunity for the new business venture. The company decides to proceed with the new project, using the feasibility report as a template for their business development process. The study helps secure funding from key decision-makers, setting this start-up product initiative up for success.

Example 2: Real estate development deal

A property developer is evaluating the feasibility of purchasing land for a new residential community. They commission a feasibility study to determine the viability of this real estate development project.

The feasibility assessment covers:

Detailed analysis of the local housing market, including demand drivers, comparable properties, pricing, and absorption rates.

Site planning to assess the property's capacity, constraints, and technological considerations.

In-depth review of legal feasibility, including zoning, permitting, environmental regulations, and other potential legal hurdles.

Financial analysis modeling various development scenarios and estimating returns on investment.

Creation of an opening day balance sheet projecting the assets, liabilities, and equity for the proposed project.

Sensitivity analysis to evaluate the impact of changes in key assumptions on the project's scope and profitability.

The feasibility study concludes that while the real estate start-up is viable, it carries significant risk. Based on these findings, the developer makes an informed decision to move forward, but with a revised project's scope and a phased approach to mitigate risk. The comprehensive feasibility analysis proves critical in guiding this major investment decision.

Which phase of the project management process involves feasibility studies?

Feasibility studies are a key part of the project initiation and planning phases. They are typically conducted after a project has been conceptualized but before significant resources are invested in detailed planning and execution.

The purpose of a feasibility assessment is to objectively evaluate the viability of a proposed project, considering factors such as technical feasibility, market demand, financial costs and benefits, legal requirements, and organizational readiness. By thoroughly assessing these aspects, a feasibility study helps project stakeholders make an informed go-or-no-go decision.

While feasibility studies are a critical tool in the early stages of project management, they differ from other planning documents like project charters, business cases, and business plans. Here's a closer look at these key differences:

Feasibility study vs. project charter

A project charter is a relatively informal document to pitch your project to stakeholders. Think of the charter as an elevator pitch for your project objectives, scope, and responsibilities. Typically, your project sponsor or executive stakeholders review the charter before ratifying the project. 

A feasibility study should be implemented after the project charter has been ratified. This isn’t a document to pitch whether or not the project is in line with your team’s goals—rather, it’s a way to ensure the project is something you and your team can accomplish.

Feasibility study vs. business case

A business case is a more formalized version of the project charter. While you’d typically create a project charter for small or straightforward initiatives, you should create a business case if you are pitching a large, complex initiative that will make a major impact on the business. This longer, more formal document will also include financial information and typically involve more senior stakeholders. 

After your business case is approved by relevant stakeholders, you'll run a feasibility study to make sure the work is doable. If you find it isn’t, you might return to your executive stakeholders and request more resources, tools, or time in order to ensure your business case is feasible.

Feasibility study vs. business plan

A business plan is a formal document outlining your organization’s goals. You typically write a business plan when founding your company or when your business is going through a significant shift. Your business plan informs a lot of other business decisions, including your three- to five-year strategic plan . 

As you implement your business and strategic plan, you’ll invest in individual projects. A feasibility study is a way to evaluate the practicality of any given individual project or initiative.

Achieve project success with Asana

Are you done with your feasibility study? You’re ready to run a project! Set your project up for success by tracking your progress with a work management tool like Asana. From the small stuff to the big picture, Asana organizes work so teams know what to do, why it matters, and how to get it done.

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What Is a Feasibility Study: Step-by-Step Guide

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Key takeaways

• A feasibility study is an essential analytical tool that evaluates the viability of a proposed project on multiple fronts, such as financials, technical requirements, and market demand.
• Conducted during the project initiation phase, this type of study serves as an early checkpoint to identify potential roadblocks and assess risks.
• Feasibility studies act as the first line of defense against project failure, saving time, money, and resources.

What is a feasibility study?

A feasibility study is an analytical tool used to evaluate the practicality of a proposed project or business idea. It assesses various factors such as financial viability, technical requirements, legal constraints, and market demand. The study aims to answer the question “Are the goals of this project realistically attainable?” by examining data, studies, and other relevant information.

A feasibility study is a crucial step to take before diving into any project and is generally performed during the project initiation phase of project management . It helps identify potential roadblocks, assess risks, and estimate resource allocation; skipping this step can lead to project failure, wasted resources, and financial losses.

Feasibility studies represent one of the many intricacies of project planning . Understanding the other requirements of this crucial step can give you a well-rounded view of how to set your project up for success.

Steps to conduct a feasibility study

Successfully executing a project hinges on thorough planning and risk assessment. Following this step-by-step guide for conducting a feasibility study will help you meticulously evaluate the viability of your project from the outset.

Step 1: Conduct preliminary analysis

This is where you take a good, hard look at your project to determine whether it’s worth pursuing. At this stage, you should also decide if a more detailed feasibility study is necessary.

A few key criteria usually come into play during this initial assessment. First, consider a general sense of the market demand for your project, the resources you have at your disposal, and some ballpark figures for initial costs. If it’s difficult to get clear estimates, it may be worthwhile to invest additional time and resources in a more comprehensive feasibility study. If no significant roadblocks pop up in this preliminary analysis, then you have the green light to proceed.

Some project management software includes useful features that can help you efficiently collect and organize all this data. These features can be very helpful in decision-making, especially when you’re looking at multiple variables.

Step 2: Create a projected income statement

This vital component of the feasibility study involves forecasting the income, expenses, and profitability associated with the proposed project. The projected income statement is akin to peering into a financial crystal ball to see how the numbers might align.

There are several approaches you can take to assess a project’s financial impact. Historical data and industry benchmarks, for example, can serve as reliable guides. These projections are important for assessing financial feasibility and making informed decisions.

The significance of these forecasts cannot be overstated — they help stakeholders understand the project’s potential ROI and ultimately make the go/no-go decision for the project.

Step 3: Survey the market

The market survey stage involves rolling up your sleeves to gather valuable data and insights about your target market(s) and audience(s). Think of it as your project’s reconnaissance mission: You’re scouting the terrain to understand what you’re getting into.

To start, you’ll want to learn your customers’ preferences to see if your project will fulfill a need or solve a problem they currently face. For example, a software company’s research might reveal customer demand for a new feature that aligns with the project’s goals.

Also consider if your project is timely and whether it will make a significant impact now or in the near future, depending on emerging market trends. It may be useful to conduct competitor research as well; knowing what and who you’re up against can help stakeholders decide whether you should move forward with the project and, if so, how you will approach it.

Surveys and interviews are ideal for firsthand quantitative and qualitative data. However, don’t underestimate the power of existing market reports. This preexisting data can offer a broad market landscape view, helping you make data-driven decisions. You can also leverage other research and data collection methods, such as focus groups and publicly available databases like Statista and the U.S. Census Bureau .

Step 4: Review and analyze the data

With all of the necessary information in hand, use tools like a SWOT analysis to evaluate the project’s strengths, weaknesses, opportunities, and threats. A risk assessment is another go-to method that can help you identify potential pitfalls that could derail your project.

At this point in the feasibility study, weigh key metrics and indicators like projected ROI, milestone dates, market penetration rates, and possible vulnerabilities. These gauges, when reviewed in tandem, paint a broader picture of your project’s viability and value.

Step 5: Determine the next steps

Use your research-backed analysis to decide whether the project you’ve proposed is the best way to address the problems it intends to address. If the metrics are favorable and the risks are manageable, you should feel confident advancing to the planning phase. Too many red flags, however, may mean you need to go back to the drawing board.

Here’s a little tech tip to make this decision easier: Many project management software dashboards can compile your key metrics and findings neatly in one visual package. It’s like having a project feasibility snapshot right at your fingertips, which makes it much easier for stakeholders to understand important data and make informed decisions.

Types of feasibility studies

There are different types of feasibility studies that each focus on a unique aspect of projects and project planning . By understanding the nuances of each, you’ll become better equipped to make well-informed decisions, mitigate risks, and ultimately steer your project toward success.

Technical feasibility

Technical feasibility digs into the nuts and bolts of the project. You’re looking at what kind of technology you’ll need, whether it’s available, and if it can be integrated into your current systems. It’s like checking if you have all the ingredients you need before cooking a specific recipe.

Economic feasibility

This study is all about the money — how much the project will cost and what kinds of economic or profitability benefits it will bring forth. With an economic feasibility study, you’re most often doing a cost-benefit analysis to see if the financials add up in your favor. It’s like weighing the pros and cons but in dollar signs. 

Legal feasibility

This is your legal checkpoint. You’re looking at any laws or regulations that might create risks or restrict your project. This feasibility study could also involve checking compliance with industry-specific or regional regulations.

Operational feasibility

An operational feasibility study will help you see how the project fits into your current operations and operational goals and resources. After completing this type of study, you should know if your project will require new workflows and if your team can handle project tasks alongside their current workloads.

This study also evaluates whether the organization has the expertise to accomplish all project goals.

Scheduling feasibility

This feasibility study is all about time. You’re considering how long the project will take and whether you can afford any delays. Gantt charts , a feature commonly found in project management software, can be convenient in this type of study.

These visual timelines allow you to map out the entire project schedule, set milestones, and identify potential bottlenecks. You can also easily see if your project’s timeline is realistic or if you need to make adjustments to avoid delays.

Feasibility study examples

Feasibility studies add value to the project lifecycle across diverse industries. With each of these examples, the feasibility study is a critical preliminary step to identify potential roadblocks and assess the likelihood of project success.

Construction

A construction project feasibility study might focus on land evaluation, zoning laws, and material costs to determine if a new housing development is viable. In this example, the study helps avoid legal snags and ensure profitable land use.

A healthcare feasibility study may assess the demand for a new medical facility in a specific location by looking at factors like local population health statistics and existing healthcare infrastructure. This type of research helps determine whether a new facility would serve the community appropriately and utilize resources effectively.

Information technology

An IT feasibility study might analyze the technical requirements, cost, and market demand for a new software application to understand whether the development effort would offer a reasonable return on investment. This information helps project teams avoid sinking time and money into software that no one wants or needs.

Free feasibility study template

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Why are feasibility studies crucial in project management?

In project management, feasibility studies help you gauge whether your project is a go or a no-go, saving you time, money, and a lot of headaches in the long run. But it’s not just about giving your project a thumbs-up or down.

Feasibility studies are also invaluable for decision-making and risk assessment. They provide the data and insights you need to make informed choices. Whether it’s deciding on the project scope, budget, or timeline, these studies offer a comprehensive view of what you’re up against.

Plus, feasibility studies help you identify potential roadblocks and risks, allowing you to prepare effective contingency plans. Operating with a feasibility study as your project’s foundation is like giving your team both a roadmap and a weather forecast to help you better navigate your project journey.

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What Is a Feasibility Study? How to Conduct One for Your Project

Why is a feasibility study so important in project management? For one, the feasibility study or feasibility analysis is the foundation upon which your project plan resides. That’s because the feasibility analysis determines the viability of your project. Now that you know the importance, read on to learn what you need to know about feasibility studies.

What Is a Feasibility Study?

A feasibility study is simply an assessment of the practicality of a proposed project plan or method. This is done by analyzing technical, economic, legal, operational and time feasibility factors. Just as the name implies, you’re asking, “Is this feasible?” For example, do you have or can you create the technology that accomplishes what you propose? Do you have the people, tools and resources necessary? And, will the project get you the ROI you expect?

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Feasibility study template

Use this free Feasibility Study Template for Word to manage your projects better.

What’s the Importance of a Feasibility Study?

A project feasibility study should be done during the project management life cycle after the business case has been completed. So, that’s the “what” and the “when” but how about the “why?” Why is it important to conduct a feasibility study?

An effective feasibility study points a project in the right direction by helping decision-makers have a holistic view of the potential benefits, disadvantages, barriers and constraints that could affect its outcome. The main purpose of a feasibility study is to determine whether the project can be not only viable but also beneficial from a technical, financial, legal and market standpoint.

What Is Included in a Feasibility Study Report?

The findings of your project feasibility study are compiled in a feasibility report that usually includes the following elements.

• Executive summary
• Description of product/service
• Technology considerations
• Product/service marketplace
• Marketing strategy
• Organization/staffing
• Financial projections
• Findings and recommendations

Free Feasibility Study Template

Use this free feasibility study template for Word to begin your own feasibility study. It has all the fundamental sections for you to get started, and it’s flexible enough to adapt to your specific needs. Download yours today.

Types of Feasibility Study

There are many things to consider when determining project feasibility, and there are different types of feasibility studies you might conduct to assess your project from different perspectives.

Pre-Feasibility Study

A pre-feasibility study, as its name suggests, it’s a process that’s undertaken before the feasibility study. It involves decision-makers and subject matter experts who will prioritize different project ideas or approaches to quickly determine whether the project has fundamental technical, financial, operational or any other evident flaws. If the project proposal is sound, a proper feasibility study will follow.

Technical Feasibility Study

A technical feasibility study consists in determining if your organization has the technical resources and expertise to meet the project requirements . A technical study focuses on assessing whether your organization has the necessary capabilities that are needed to execute a project, such as the production capacity, facility needs, raw materials, supply chain and other inputs. In addition to these production inputs, you should also consider other factors such as regulatory compliance requirements or standards for your products or services.

Economic Feasibility Study

Also called financial feasibility study, this type of study allows you to determine whether a project is financially feasible. Economic feasibility studies require the following steps:

• Before you can start your project, you’ll need to determine the seed capital, working capital and any other capital requirements, such as contingency capital. To do this, you’ll need to estimate what types of resources will be needed for the execution of your project, such as raw materials, equipment and labor.
• Once you’ve determined what project resources are needed, you should use a cost breakdown structure to identify all your project costs.
• Identify potential sources of funding such as loans or investments from angel investors or venture capitalists.
• Estimate the expected revenue, profit margin and return on investment of your project by conducting a cost-benefit analysis , or by using business forecasting techniques such as linear programming to estimate different future outcomes under different levels of production, demand and sales.
• Estimate your project’s break-even point.
• Conduct a financial benchmark analysis with industrial averages and specific competitors in your industry.
• Use pro forma cash flow statements, financial statements, balance sheets and other financial projection documents.

Legal Feasibility Study

Your project must meet legal requirements including laws and regulations that apply to all activities and deliverables in your project scope . In addition, think about the most favorable legal structure for your organization and its investors. Each business legal structure has advantages and disadvantages when it comes to liability for business owners, such as limited liability companies (LLCs) or corporations, which reduce the liability for each business partner.

Market Feasibility Study

A market feasibility study determines whether your project has the potential to succeed in the market. To do so, you’ll need to analyze the following factors:

• Industry overview: Assess your industry, such as year-over-year growth, identify key direct and indirect competitors, availability of supplies and any other trends that might affect the future of the industry and your project.
• SWOT analysis: A SWOT analysis allows organizations to determine how competitive an organization can be by examining its strengths, weaknesses and the opportunities and threats of the market. Strengths are the operational capabilities or competitive advantages that allow an organization to outperform its competitors such as lower costs, faster production or intellectual property. Weaknesses are areas where your business might be outperformed by competitors. Opportunities are external, such as an underserved market, an increased demand for your products or favorable economic conditions. Threats are also external factors that might affect your ability to do well in the market such as new competitors, substitute products and new technologies.
• Market research: The main purpose of market research is to determine whether it’s possible for your organization to enter the market or if there are barriers to entry or constraints that might affect your ability to compete. Consider variables such as pricing, your unique value proposition, customer demand, new technologies, market trends and any other factors that affect how your business will serve your customers. Use market research techniques to identify your target market, create buyer personas, assess the competitiveness of your niche and gauge customer demand, among other things.

7 Steps to Do a Feasibility Study

If you’re ready to do your own feasibility study, follow these 7 steps. You can use this free feasibility study template to help you get started.

1. Conduct a Preliminary Analysis

Begin by outlining your project plan . You should focus on an unserved need, a market where the demand is greater than the supply and whether the product or service has a distinct advantage. Then, determine if the feasibility factors are too high to clear (i.e. too expensive, unable to effectively market, etc.).

2. Prepare a Projected Income Statement

This step requires working backward. Start with what you expect the income from the project to be and then what project funding is needed to achieve that goal. This is the foundation of an income statement. Factor in what services are required and how much they’ll cost and any adjustments to revenues, such as reimbursements, etc.

Related: Free Project Management Templates

3. Conduct a Market Survey or Perform Market Research

This step is key to the success of your feasibility study, so make your market analysis as thorough as possible. It’s so important that if your organization doesn’t have the resources to do a proper one, then it is advantageous to hire an outside firm to do so.

Market research will give you the clearest picture of the revenues and return on investment you can realistically expect from the project. Some things to consider are the geographic influence on the market, demographics, analyzing competitors, the value of the market and what your share will be and if the market is open to expansion (that is, in response to your offer).

4. Plan Business Organization and Operations

Once the groundwork of the previous steps has been laid, it’s time to set up the organization and operations of the planned project to meet its technical, operational, economic and legal feasibility factors. This isn’t a superficial, broad-stroke endeavor. It should be thorough and include start-up costs, fixed investments and operating costs. These costs address things such as equipment, merchandising methods, real estate, personnel, supply availability, overhead, etc.

5. Prepare an Opening Day Balance Sheet

This includes an estimate of the assets and liabilities, one that should be as accurate as possible. To do this, create a list that includes items, sources, costs and available financing. Liabilities to consider are such things as leasing or purchasing land, buildings and equipment, financing for assets and accounts receivables.

6. Review and Analyze All Data

All of these steps are important, but the review and analysis are especially important to ensure that everything is as it should be and that nothing requires changing or tweaking. Take a moment to look over your work one last time.

Reexamine your previous steps, such as the income statement, and compare them with your expenses and liabilities. Is it still realistic? This is also the time to think about risk and come up with any contingency plans .

7. Make a Go/No-Go Decision

You’re now at the point to make a decision about whether or not the project is feasible. That sounds simple, but all the previous steps lead to this decision-making moment. A couple of other things to consider before making that binary choice are whether the commitment is worth the time, effort and money and whether it aligns with the organization’s strategic goals and long-term aspirations.

Feasibility Study Examples

Here are some simple feasibility study examples so you have a better idea of what a feasibility study is used for in different industries.

Construction Feasibility Study

For this construction feasibility study example, let’s imagine a large construction company that’s interested in starting a new project in the near future to generate profits.

• Pre-Feasibility Study: The first step is to conduct a preliminary feasibility study. It can be as simple as a meeting where decision-makers will prioritize projects and discuss different project ideas to determine which poses a bigger financial benefit for the organization.
• Technical Feasibility Study: Now it’s time to estimate what resources are needed to execute the construction project, such as raw materials, equipment and labor. If there’s work that can’t be executed by the company with its current resources, a subcontractor will be hired to fill the gap.
• Economic Feasibility Study: Once the construction project management team has established what materials, equipment and labor are needed, they can estimate costs. Cost estimators use information from past projects, construction drawings and documents such as a bill of quantities to come up with an accurate cost estimate. Then, based on this estimate, a profit margin and financial forecasts will be analyzed to determine if there’s economic feasibility.
• Legal Feasibility Study: Now the company needs to identify all potential regulations, building codes and laws that might affect the project. They’ll need to ask for approval from the local government so that they can begin the construction project .
• Market Feasibility Study: Market feasibility will be determined depending on the nature of the project. For this feasibility example, let’s assume a residential construction project will be built. To gauge market potential, they’ll need to analyze variables such as the average income of the households in the city, crime rate, population density and any trends in state migration.

Manufacturing Feasibility Study

Another industry that uses feasibility studies is manufacturing. It’s a test run of the steps in the manufacturing production cycle to ensure the process is designed properly. Let’s take a look at what a manufacturing feasibility study example would look like.

• Feasibility Study: The first step is to look at various ideas and decide which is the best one to pursue. You don’t want to get started and have to stop. That’s a waste of time, money and effort. Look at what you intend to manufacture, does it fill an unserved need, is the market able to support competition and can you manufacture a quality product on time and within your budget?
• Financial Feasibility Study: Find out if your estimated income from the sale of this product is going to cover your costs, both direct and indirect costs. Work backward from the income you expect to make and the expenses you’ll spend for labor, materials and production to determine if the manufacturing of this product is financially feasible.
• Market Feasibility Study: You’ve already determined that there’s a need that’s not being served, but now it’s time to dig deeper to get realistic projections of revenue. You’ll want to define your target demographic, analyze the competitive landscape, determine the total market volume and what your market share will be and estimate what market expansion opportunities there are.
• Technical Feasibility Study: This is where you’ll explore the production , such as what resources you’ll need to produce your product. These findings will inform your financial feasibility study as well as labor, material, equipment, etc., costs have to be within your budget. You’ll also figure out the processes you’ll use to produce and deliver your product to the market, including warehousing and retail distribution.

There could be other feasibility studies you’ll have to make depending on the product and the market, but these are the essential ones that all manufacturers have to look at before they can make an educated decision as to whether to go forward or abandon the idea.

Best Practices for a Feasibility Study

• Use project management software like ProjectManager to organize your data and work efficiently and effectively
• Use templates or any data and technology that gives you leverage
• Involve the appropriate stakeholders to get their feedback
• Use market research to further your data collection
• Do your homework and ask questions to make sure your data is solid

If your project is feasible, then the real work begins. ProjectManager helps you plan more efficiently. Our online Gantt chart organizes tasks, sets deadlines, adds priority and links dependent tasks to avoid delays. But unlike other Gantt software, we calculate the critical path for you and set a baseline to measure project variance once you move into the execution phase.

Watch a Video on Feasibility Studies

There are many steps and aspects to a project feasibility study. If you want yours to be accurate and forecast correctly whether your project is doable, then you need to have a clear understanding of all its moving parts.

Jennifer Bridges, PMP, is an expert on all aspects of project management and leads this free training video to help you get a firm handle on the subject.

Here’s a screenshot for your reference!

Pro tip: When completing a feasibility study, it’s always good to have a contingency plan that you test to make sure it’s a viable alternative.

ProjectManager Improves Your Feasibility Study

A feasibility study is a project, so get yourself a project management software that can help you execute it. ProjectManager is an award-winning software that can help you manage your feasibility study through every phase.

Once you have a plan for your feasibility study, upload that task list to our software and all your work is populated in our online Gantt chart. Now you can assign tasks to team members, add costs, create timelines, collect all the market research and attach notes at the task level. This gives people a plan to work off of, and a collaborative platform to collect ideas and comments.

If you decide to implement the project, you already have it started in our software, which can now help you monitor and report on its progress. Try it for yourself with this free 30-day trial.

Transcription

Today we’re talking about How to Conduct A Feasibility Study, but first of all, I want to start with clarifying what a feasibility study is.

Feasibility Analysis Definition

Basically, it’s an assessment of the practicality of a proposed plan or method. Basically, we’ll want to want to know, is this feasible. Some of the questions that may generate this or we can hear people asking are, “Do we have or can we create the technology to do this? Do we have the people resource who can produce this and will we get our ROI, our Return On Investment?”

When to Do a Feasibility Study

So when do we do the feasibility study? So it’s done during a project lifecycle and it’s done after the business case because the business case outlines what we’re proposing. Is it a product or service that we’re proposing?

So why do we do this? The reason we do this is that we need to determine the factors that will make the business opportunity a success.

How to Conduct a Feasibility Study

Well, let’s talk about a few steps that we do in order to conduct the feasibility study.

Well, first of all, we conduct a preliminary analysis of what all’s involved in the business case and what we’re analyzing and what we’re trying to determine is feasible.

Then we prepare a projected income statement. We need to know what are the income streams, how are we gonna make money on this. Where’s the revenue coming from? We also need to conduct a market survey.

We need to know, is this a demand? Is there a market for this? Are customers willing to use this product or use this service?

The fourth one is to plan the business organization and operations. What is the structure, what kind of resources do we need? What kind of staffing requirements do we have?

We also want to prepare an opening day balance sheet. What are the…how again, what are the expenses, what’s the revenue and to ensure that being able to determine if we’re gonna make our ROI.

So we want to review and analyze all of the data that we have and with that, we’re going to determine, we’re going to make a go, no-go decision. Meaning, are we going to do this project or this business opportunity or not.

Well, here are some of the best practices to use during your feasibility study.

One is to use templates, tools and surveys that exist today. The great news is, data is becoming more and more prevalent. There are all kinds of technologies. There are groups that they do nothing but research. Things that we can leverage today.

We want to involve the appropriate stakeholders to ensure that input is being considered from the different people involved.

We also want to use again the market research to ensure we’re bringing in good, reliable data.

Do your homework, meaning act like is if this is your project, if it’s your money. So do your homework and do it well and make sure you give credible data.

What Is a Feasibility Report?

So ultimately in the end what we’re doing is, we’re producing and we’re providing a feasibility report. So in that report, think of this is like a template.

So what you’re gonna do is give it an executive summary of the business opportunity that you’re evaluating and the description of the product or the service.

You want to look at different technology considerations. Is it technology that you’re going to use? Are you going to build the technology?

What kind of product and service marketplace and being able again, to identify the specific market you’re going to be targeting? Also, what is the marketing strategy you’re going to use to target the marketplace?

And also what’s the organizational structure? What are the staffing requirements? What people do you need to deliver the product or service and even support it?

So also we want to know the schedule to be able to have the milestones to ensure that as we’re building things, that as we’re spending money that we’re beginning to bring in income to pay and knowing when we’re going to start recuperating some of the funding. Again, which also ties into the financial projections.

Ultimately in this report, you’re going to provide the findings and the recommendations.

Again, we’ll probably talk about technology. Are you going to build it? Are you going to buy it? What are the marketing strategies for the specific marketplace organization? You may have some recommendations for whether you’re going to insource the staff, maybe you are going to outsource some staff and what that looks like and also financial recommendation.

If you’ve been looking for an all-in-one tool that can help with your feasibility study, consider ProjectManager. We offer five project views and countless features that make it seamless to plan projects, organize tasks and stay connected with your team. See what our software can do for you by taking this free 30-day trial.

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Are some feasibility studies more feasible than others? A review of the outcomes of feasibility studies on the ISRCTN registry

1 National Institute for Health Research Central Commissioning Facility, Twickenham, UK

Jennie Hejdenberg

Kasia kuleszewicz, david armstrong.

2 Department of Primary Care & Public Health Sciences, King’s College London, London, UK

Sue Ziebland

3 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK

Associated Data

All data generated or analysed during this study are included in this published article and its supplementary information files.

Feasibility studies are often conducted before committing to a randomised controlled trial (RCT), yet there is little published evidence to inform how useful feasibility studies are, especially in terms of adding or reducing waste in research. This study attempted to examine how many feasibility studies demonstrated that the full trial was feasible and whether some feasibility studies were inherently likely to be feasible or not feasible, based on the topic area and/or research setting.

Keyword searches were conducted on the International Standard Randomised Controlled Trials Number (ISRCTN) registry to identify all completed feasibility studies which had been conducted in the UK.

A total of 625 records from the 1933 identified were reviewed before it became evident that it would be futile to continue. Of 329 feasibility studies identified, 160 had a known outcome (49%), 133 (83%) trials were deemed to be feasible and only 27 (17%) were reported to be non-feasible. There were therefore too few studies to allow the intended comparison of differences in non-feasible studies by topic and/or setting.

Conclusions

There were too few studies reported as non-feasible to draw any useful conclusions on whether topic and/or setting had an effect. However, the high feasibility rate (83%) may suggest that non-feasible studies are subject to publication bias or that many feasible studies are redundant and may be adding waste to the research pathway.

Large randomised controlled trials (RCTs) are expensive and time-consuming and often require substantial and sustained commitment from patients and clinical staff. It has become increasingly common to conduct preliminary studies, often using a pilot or feasibility design, to mitigate the risks and financial commitment involved in running a multicentre RCT. As demonstrated by Chalmers and Glasziou, a substantial amount of research waste occurs when inappropriate questions are asked, inappropriate methods used and the results are inappropriately reported or not made available [ 1 , 2 ]. Getting this right in large clinical trials matters and preliminary, feasibility studies ought to help. In this study, we used the definition by Eldridge et al. [ 3 ], which considers pilot studies as a subset of feasibility studies in preparation for a future RCT.

There have been very few studies examining whether feasibility studies really do succeed in mitigating risks and improving trial design, rather than simply adding another layer of time and expense to the research pathway. One such example, Charlesworth et al. showed that only 53.8% of correctly labelled pilot studies reported in six anaesthesia journals had progressed into a subsequent study 5 (or more) years later [ 4 ].

Research examining the conduct of feasibility studies has concluded that these are often suboptimal and has proposed recommendations to improve how the studies should be described, conducted and reported. Contributions include the conceptual framework developed by Eldridge et al. [ 3 ], Thabane & Lancaster’s guide to the reporting of protocols of pilot and feasibility trials [ 5 ], the CONSORT extension checklist for reporting pilot studies [ 6 ] and a specific website for pilot and feasibility studies which hosts various resources to aid researchers in the design, analysis and reporting of studies [ 7 ].

Whilst these contributions [ 4 – 7 ] take an overarching perspective on the design and conduct of feasibility studies, a recent trend has focussed on their role and effectiveness in specific disciplines or in particular trial designs. Kosa et al. found that pilot studies in chronic kidney disease patients on haemodialysis did not typically adhere to CONSORT reporting guidelines; however, improvements were noted in the reports of larger and more recent studies [ 8 ]. Fairhurst et al. concluded that pilot and feasibility studies conducted in surgery fail to fully address the uncertainties specifically related to surgical RCTs and instead focus on generic uncertainties [ 9 ]. Charlesworth et al.’s review of six anaesthesia journals found that only 12.8% of the studies described as ‘pilot studies’ met the agreed criteria. They concluded that better reporting in line with CONSORT was needed [ 4 ]. Relating more to methods than discipline, Rosala-Hallas et al. reviewed internal pilots of the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme and showed that not all had clear progression criteria, and in some cases, studies would progress to a full RCT without the criteria being met [ 10 ]. Kristunas et al. reviewed the role of feasibility studies in stepped-wedge cluster randomised trials. Few relevant studies were found and most of these did not examine the specific challenges associated with conducting stepped-wedge cluster randomised trials [ 11 ].

Whilst these reports address the quality of feasibility studies, few studies have addressed whether feasibility studies can mitigate risk and improve trial design. Previous analysis of feasibility studies funded by the National Institute for Health Research’s (NIHR) Research for Patient Benefit’s (RfPB) programme showed that on average a feasibility study demonstrated that the RCT was feasible in 64% of cases [ 12 ]. The average cost of a feasibility study was £219,048 and took 31 months to complete. A typical RCT following an RfPB feasibility study costs on average £1,163,996 and took 42 months to complete. Thus, a significant amount of time and funding is spent on feasibility studies: is this a good use of resources?

Whilst there are clear reporting guidelines for pilot and feasibility studies and materials to help researchers conduct these studies more appropriately, the available evidence suggests many pilot and feasibility studies are still poorly conducted and reported. It seems likely therefore that these studies are not currently reaching their full potential to help reduce waste in research.

Researchers and research funders have more to learn about whether and how pilot and feasibility studies add value. There may, for example, be nuances related to particular disciplines or methods. When reviewing the RfPB feasibility studies [ 12 ], it was noted that although the overall feasibility rate was 64%, it appeared to vary by research topic and settings. The RfPB data did not include sufficient studies to answer this question with confidence, yet, given the time and expense involved in RCTs, it is worth exploring whether feasibility studies in certain topics or settings are more likely to indicate that an RCT is feasible.

To answer this question, we examined feasibility studies registered on the International Standard Randomised Controlled Trials Number (ISRCTN) registry. If we could establish that feasibility studies in certain topic areas or settings were more or less feasible than the RfPB average of 64%, it could provide researchers and funders with better information before committing to a particular feasibility study. For example, if some feasibility studies in certain topics/settings had a high chance of demonstrating feasibility, it may be more appropriate to go straight to RCT as there is less risk involved. Alternatively, if we discovered that feasibility studies in certain topic areas or settings often indicated that an RCT would not be feasible—and we could determine the reasons why—it could help researchers to design more appropriate studies. We therefore set about examining the extent to which feasibility studies reported in a large trials database (ISRCTN) found a potential trial was ‘not feasible’ and whether this latter finding varied for clinical topics and settings.

A keyword search was conducted on 03 March 2019 on the ISRCTN database using the search terms ‘pilot’, ‘feasibility’ and ‘feasible’. Data were extracted in Microsoft Excel. Duplicate entries were removed. The unique list of records was filtered by ‘Country of recruitment’ as ‘UK’ and ‘Overall trial status’ as ‘Complete’. ‘Condition Category’ was used to determine the research topic area and ‘Trial Setting’ was used to determine the research setting. ‘Condition Category’ is selected by ISRCTN editorial staff and is based on International Classification of Diseases (ICD) – 10. ‘Trial Setting’ is a self-reported option researchers select from a dropdown list [ 13 ].

Using Eldridge et al.’s [ 3 ] view of pilot and feasibility studies as preparatory studies for a future RCT, with pilot studies as a subset of feasibility studies, the individual records were reviewed independently by two authors to determine:

If the research was a feasibility study (i.e. explicitly stated it was preparing for a RCT and had typical feasibility outcomes (for clarity studies described as pilot studies were included if explicitly stated to be in preparation for a RCT).

Findings and interpretations reported by the researchers in their results papers were then used to determine:

• If the research was a feasibility study, did it demonstrate the RCT to be feasible?
• If it was a feasibility study and the RCT was not feasible, the reasons why it was not feasible

Specific reasons given for why a RCT was not feasible (item 3) were themed into:

• Patient recruitment—where difficulties were encountered in recruiting and/or retaining the participants during the study or low eligibility of patients
• Trial design/methods—where difficulties were encountered in blinding, inappropriate inclusion/exclusion criteria, general method/design issues
• Intervention—where the intervention lacked sufficient promise of efficacy/effectiveness, was not used by participants, or was not practical
• Outcome measures—where outcome measures were not acceptable or could not be collected.

Where multiple reasons why a RCT was not feasible were reported, these were counted separately, i.e. a single feasibility study could have more than one reason why the RCT was not feasible.

The inter-rater reliability was calculated using percentage agreement between raters. Where there was disagreement between the two reviewers on points 1, 2 or 3, a third reviewer adjudicated.

The sources of information to answer points 1, 2 or 3 were:

• The content on the ISCTRN record
• Links to published papers from the ISCTRN record
• Where no links to published papers were noted in the ISCTRN records, a search was conducted on Europe PMC to see if any published papers could be found. Only papers with a clear link to the research were included, e.g. ISRCTN number referenced in the paper.

Where there were multiple sources of information available for a single study, such as the ISRCTN record, a protocol paper and results paper we used the latest available information, for example, results papers were used over protocol papers, and protocol papers were used over the ISRCTN records, etc.

A total of 1933 unique study entries were returned from the keyword searches once filters had been applied to ‘Country of recruitment’ as ‘UK’ and ‘Overall trial status’ as ‘Complete’. Whilst reviewing the records, it became clear there would be an insufficient number of studies where the RCT was considered not feasible to make a credible assessment of whether research topic and/or research setting were related to conclusions about feasibility. Having found only 27 non-feasible studies from an initially randomly selected pool of 625 records, we estimated that the whole dataset of 1933 records would be unlikely to yield more than 84 non-feasible studies, an insufficient number to evaluate the effect of clinical topic or setting. Therefore, only 625 records were included in the analysis below. The 625 studies had trial end dates between 1995 and 2019 with the distribution shown in Table ​ Table1. 1 . From the 625 records reviewed, only 329 (53%) were agreed to be feasibility studies, using the Eldridge definition (3).

Distribution of ISRCTN records by trial end date

Of the 329 identified as feasibility studies:

• 133 studies (40%) indicated that the RCT was feasible
• 27 studies (8%) indicated that the RCT was not feasible
• For 160 studies (49%), the outcome was unknown because no results could be found
• 97 studies (61%) of these 160 studies were within 24 months of ‘Overall trial end’ while 63 studies (39%) had not published results between two and twenty years since the ‘Overall trial end’
• In 8 studies (2%), it was unclear if they were feasibility studies or not due to insufficient reported detail
• 1 study terminated before it started

Therefore, from the 160 records with known feasibility outcomes, 133 (83%) concluded that the RCT was feasible and 27 (17%) that the RCT was not feasible. The interrater reliability across the three rating points was 84%.

The breakdown of the results by topic and setting are presented in Tables ​ Tables2 2 and ​ and3, 3 , albeit based on small numbers in Table ​ Table2, 2 , where there were at least 10 studies reported for a specific research topic, the feasibility rate ranged between 79% and 100% for individual research topics, and in Table ​ Table3, 3 , the feasibility rate ranged between 73% and 93% for research setting.

Breakdown of research topic area and whether RCT was feasible or not feasible for studies with known outcomes

Breakdown of research setting and whether RCT was feasible or not feasible for studies with known outcomes

Figure ​ Figure1 1 shows the specific reasons RCTs were deemed not to be feasible, irrespective of research topic area or research setting, with patient recruitment clearly being the most common reason and reported for 18 (60%) of the 27 feasibility studies reporting the RCT to be not feasible.

Reasons why RCTs were not feasible

The largest outcome group was ‘unknown if RCT feasible’ ( n = 160) which was where the feasibility study had completed but the published results could not be found. The trial end date of these studies ranged from 1999 to 2019. Sixty three of the 160 studies had trial end dates at least 2 years before our data access and therefore would have had ample time to publish. This suggests that there is a large amount of under-reporting of results of feasibility studies which is consistent with the general under-reporting of trials [ 14 – 18 ].

It was not possible to determine whether certain research topics and/or research settings are more associated with feasibility because we found too few studies reporting that the RCT was not feasible. Irrespective of research topic or research setting, there were consistent reasons why RCTs were considered not feasible: patient recruitment, trial design/methods, intervention and outcome measures. Of these, patient recruitment was the most commonly reported reason in the published results paper. This will not be a controversial finding for the research and funding community.

There are several plausible reasons why studies showing that RCTs are not feasible do not often appear in the literature. First, whilst feasibility studies are typically smaller than RCTs, it is clear from RfPB data [ 12 ] that feasibility studies are still a large investment of resource costing on average £219,048 and taking 31 months. Research teams may be confident (and persuasive) enough to apply for the full RCT, perhaps including an internal pilot. Second, it is becoming more routine to include feasibility progression criteria in feasibility designs with ‘red, amber, green’ pre-specified assessments to indicate feasibility. Many of the studies we reviewed did not use progression criteria or used unclear criteria. Therefore, it is very plausible that some studies were optimistic in reporting the RCT to be feasible. We also noted examples where researchers had reported the RCT feasible subject to such substantial changes that it was debatable what relation the feasibility study could claim to any eventual RCT. Third, the bar to demonstrate feasibility may be artificially low if studies are not identifying and addressing the specific challenges in the clinical field of interest. This may be accentuated if feasibility studies rely on a formulaic design [ 8 ]. Fourth, the team may be reluctant to publish the conclusion that a trial is not feasible. Historically, there have been challenges publishing ‘negative results’, but recent advances such as better reporting guidance (CONSORT) and specialist journals such as Pilot and Feasibility Studies have helped to address these challenges. Looking at the 160 studies that apparently had no results published, 63 had finished more than 2 years before our data access and thus would have had ample time to publish. The remaining 97 studies may well go on to publish non-feasible conclusions in future. Therefore, future reviews of feasibility studies might show a more complete publication picture.

There were some challenges in reviewing the ISRCTN records. Firstly, although we used a clear definition of what constitutes a feasibility study, to some extent, we were retro-fitting a definition to previously funded research. Nevertheless, we took the view that any study that explicitly stated it was preparing for a RCT, and had typical feasibility outcomes, was eligible for inclusion. One particular challenge was the number of studies that identified as pilot studies yet had no explicit plan to conduct a further RCT. Some included a mix of typical feasibility study outcomes and typical pilot study outcomes. These were typically excluded if they were primarily exploratory studies or even underpowered trials. Another challenge from the ISRCTN records was that we found self-identified feasibility studies which were examining the feasibility of implementation of a particular treatment/service rather than examining whether a future RCT was feasible. Studies that were not planning to progress to a RCT were excluded but were often challenging to identify.

It is clear from the data that more feasibility studies, or at least more studies which resemble current definitions of feasibility studies, are being conducted, with over 97 feasibility studies completing in 2018 compared with 21 10 years earlier and two 10 years before that. This follows the trend of more focus on feasibility studies with activity such as more research, specialised journals and better guidance on designing, conducting and reporting feasibility studies. It would be interesting to understand why more feasibility studies are being conducted. Could it be that funders of RCTs require more evidence that expensive RCTs will be successfully delivered? Perhaps there are also more funding opportunities for feasibility studies with NIHR programmes like RfPB becoming well known for supporting such studies. It is likely that more feasibility studies are now included on trial registries and were therefore discoverable.

Whilst the majority of the feasibility studies with reported outcomes are feasible, it would have been useful to have known how many studies progressed to RCT and how long they took to progress to have a better-informed view of the utility of feasibility studies. Whilst we noticed that some ISRCTN records contained both the feasibility study and subsequent RCT in a single ISRCTN record, it was not clear how systematically these records were updated. It would be useful if trial registries collected more data including links between feasibility studies and RCTs and ultimately outcomes from RCTs. Knowing the full picture from feasibility study progression to RCT competition and study outcome would allow a more informed view on how feasibility studies contribute to the trials pathway.

It is reasonable to assume that if the feasibility rate is too high, then researchers and research funders are contributing to the waste in the system by conducting studies which will often show the RCT is feasible. In such cases, it may be more appropriate to go straight to the RCT and accept that a relatively small percent will inevitably fail, whilst noting that feasibility studies do help address other uncertainties which may not have been foreseen. Conversely, if the feasibility rate is too low, it may indicate that researchers and funders are too optimistic and commit to studies which are not likely to progress down the trials pathway, although based on the current analysis, there is insufficient evidence to suggest that this scenario is occurring. However, it is acknowledged that many useful aspects and insights are gained via feasibility studies and that those demonstrating the RCT to be feasible often do once addressing challenges encountered via the feasibility study.

There must be a point where if the feasibility rate is too high it would be more cost and time effective to fund studies as RCTs and accept that a certain percentage will inevitably fail. However, for those that do fail, a greater amount of time and/or funding will have been saved by successfully completed RCTs which avoided the feasibility and/or pilot step. The cost of the ISRCTN feasibility studies was not reported, but based on the previous RfPB review [ 12 ], the average feasibility study cost £219,048 and took 31 months. If the 83% feasibility rate of ISRCTN studies is correct, then that is a substantial amount of funding and time taken up by the feasibility studies when only approximately 1 in 5 will show the RCT to not be feasible. Using the average cost of feasibility studies (£219,048) and RCTs (£1,163,996) from our previous review of RfPB studies [ 12 ], we can begin to estimate what an appropriate feasibility rate may be. RfPB feasibility studies were shown to be feasible in approximately two out of three studies, and therefore approximately £657,144 was spent on feasibility studies to save up to approximately £1,163,996 for the RCT which was not feasible. If we apply the same estimates based on the ISRCTN feasibility rate of 83% (approximately four out of five studies), then approximately £1,095,240 needs to be spent on feasibility studies to save up to approximately £1,163,996 for the RCT which was not feasible. In addition to cost, there is also a time addition as each feasibility study takes an average 31 months to complete. A feasibility rate of 83% appears too high and would suggest feasibility studies are wasteful, whereas 64% may be considered more reasonable.

How many of these RCTs genuinely needed a feasibility study and then focussed on the actual uncertainties instead of adopting a generic design? Perhaps even more important is how many of those 83% which demonstrate feasibility actually progress to RCT? Feasibility studies which show the RCT feasible but which do not progress to RCT, for various reasons, could also be considered to be adding to research waste, especially if these feasibility studies are not really needed in the first place. The answer to this question is made challenging by historic poor reporting and publication rates of feasibility studies.

This study raises, but cannot address, the question of what would be an acceptable ‘success’ rate for feasibility studies: should most demonstrate feasibility of the RCT or should more demonstrate the RCT not feasible? How much risk do funders and researchers want to take? Might shorter and more cost effective feasibility studies be more informative? Perhaps the view that feasibility studies are essential before conducting a RCT is leading to the design of studies which are likely to ‘succeed’ and therefore lack equipoise or do not focus on the most important uncertainties which need to be addressed in relation to the specific trial. As shown by the existing literature, it is often the case that feasibility studies in certain topic areas do not maximise their potential benefit and focus on the key uncertainties [ 8 , 11 ] and instead adopt a generic design.

Although we were unable to answer our initial question, a potentially more important and interesting question is what the rate of feasibility studies demonstrating the RCT is feasible should be. The previous review of the RfPB portfolio [ 12 ] showed that 64% of studies demonstrated the RCT to be feasible and this review of ISRCTN registered studies showed that 83% of studies with known/published outcomes demonstrated the RCT feasible. Are these feasibility rates appropriate and what do they mean for the wider trajectory along the trials pathway?

It is likely that there are insufficient published studies demonstrating that the RCT is not feasible to be able to assess whether some studies may or may not be more feasible than average based on research topic and/or research setting. More discussion is required between researchers, methodologists and research funders on exactly what feasibility studies are aiming to achieve and what proportion of studies should demonstrate feasibility or not and how this relates to the wider research, funder and patient benefit pathway. This will help ensure that feasibility studies maximise the potential to reduce waste in research instead of potentially adding to it.

Limitations

The sample included a range of studies spanning over 20 years. During this time, research design and conduct has changed including definitions of ‘feasibility study’. To that end, we applied a relatively recent definition of ‘feasibility study’ to historical studies which made reviewing studies challenging. The potential under-reporting of non-feasible studies possibly biased the sample leading to an artificially high feasibility rate.

Acknowledgements

SZ is an NIHR Senior Investigator Emerita.

Authors’ contributions

BM, JH, DA and SZ conceived the study. The work was undertaken by BM, JH and KK and supported by DA and SZ. Analysis and quality assurance were conducted by BM, JH and KK. All authors read and approved the final manuscript.

This study was funded by the NIHR Central Commissioning Facility (CCF).

Availability of data and materials

Declarations.

Not applicable

BM, JH and KK are employed through NIHR to manage RfPB and its databases. SZ is the current Programme Director of RfPB, and DA was the Programme Director of RfPB until May 2017. The views expressed are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and social Care.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Levy to Present Feasibility Study Results of First Permanently Implanted Brain-Computer Interface at CNS

Elad I. Levy, MD, MBA, a principal investigator on the Synchron clinical trial, is holding the engineered precision 3-D printed model of a patient’s anatomy and vascular structures that was created by bioengineers at the Jacobs Institute. 

Receiving Duke Samson Award for Abstract on COMMAND Trial of Synchron’s Neuroprosthetic

By Ellen Goldbaum

Release Date: September 26, 2024

BUFFALO, N.Y. – Results of the clinical trial that assessed the safety of Synchron’s endovascular brain-computer interface in people with severe paralysis will be presented Sept. 30 at the Congress of Neurological Surgeons (CNS).

The results will be presented by  Elad I. Levy, MD, MBA , a principal investigator, SUNY Distinguished Professor and the L. Nelson Hopkins, MD, Professor and Chair of the  Department of Neurosurgery  in the  Jacobs School of Medicine and Biomedical Sciences  at the University at Buffalo. Levy also is co-director of the  Gates Stroke Center  and Cerebrovascular Surgery at Kaleida Health’s Buffalo General Medical Center/Gates Vascular Institute (GVI) and president of  UB Neurosurgery  (UBNS).

For this abstract, Levy is being awarded the Duke Samson Award, which the CNS gives to recognize the best clinical paper addressing a topic of cerebrovascular surgery.

Now that the initial follow-up of the feasibility study has been completed, patients will begin to be enrolled next year at additional sites in the U.S., one of which will be the GVI in Buffalo.

Technology Uses Digital Motor Output

The COMMAND trial was conducted under the first investigational device exemption awarded by the Food and Drug Administration to a company assessing a permanently implanted brain-computer interface. The early feasibility study assessed safety while evaluating quantified efficacy measures of Synchron’s brain-computer interface device, which allows people with limited to no mobility to operate technology such as mobile devices and computers using their thoughts. The Synchron technology uses digital motor output, or DMO, to use peripheral assist devices to restore lost function.

Through a minimally-invasive endovascular procedure, the device is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein. Once implanted, it is designed to detect and wirelessly transmit motor intent out of the brain, intended to restore the capability for severely paralyzed people to have hands-free control over personal devices.

In the study, two patients were enrolled in Buffalo at the Gates Vascular Institute, two were enrolled at the University of Pittsburgh and two at Mount Sinai Health System.

Levy explains that the technology is designed to give functional independence back to patients who have become paralyzed.

“It takes a person who has to have everything done by a caretaker and it gives them back some independence and functionality through this brain-computer interface,” he says.

Buffalo Was a Natural Choice

“Our group at UB and the GVI has been in the forefront of learning how to navigate complex devices in the venous system of the brain,” says Levy, “so it was a very natural choice for Synchron to come to Buffalo and have us do these initial cases. All of the research that we’ve done pioneering in strokes and, more specifically, in venous anatomy at the Jacobs School, as well as the clinical experience we have at Gates, was the reason we were selected to be one of the first places where this kind of procedure would be done.”

Allison Brashear, MD, MBA , UB’s vice president for health sciences and dean of the Jacobs School, says: “That our UB and Gates Vascular Institute neurosurgeons were selected to do this points to the fact that for the last 20 years, they have been at the forefront of neuroendovascular surgery, delivering paradigm-changing care to patients not only in this region but globally. This continued pursuit of advanced technologies highlights our commitment to innovation and excellence in patient care.”

The strong partnership between the Department of Neurosurgery, the GVI and the Jacobs Institute allowed the Buffalo group to optimize the procedures before touching the patient. The Jacobs Institute is a vascular and neurologic medical device innovation center on the Buffalo Niagara Medical Campus.

Through this partnership, the bioengineers at the Jacobs Institute created engineered precision 3D printed models to scale of a patient’s anatomy and vascular structures.

“This allows us to continue to optimize and practice our procedures,” says Levy, “becoming very familiar with the patient’s brain anatomy so that when we do implant these incredibly expensive devices into these very fragile patients, we can do it flawlessly.”

‘Almost Like Science Fiction’

Rosalind Lai, MD , assistant professor of neurosurgery at UB, who was at the time a UB neurosurgery fellow, says she felt privileged to be part of the team. “It was very exciting to be part of this cutting-edge neurosurgery. It was almost like science fiction,” she says. “It’s so remarkable because they implanted the device endovascularly through a catheter in the neck, through the venous system and up into the superior sagittal sinus at the top of the head. Then they threaded the electrode to the motor cortex in the venous sinus system and landed it there precisely.”

The electrode connects to a telemetry device in the patient’s chest.

Levy notes that this trial has provided invaluable lessons for the team that planned and developed the procedure, including neurosurgical residents and fellows at UB.

“Using computer software planning, we pinpointed with submillimeter accuracy precisely where the implantable stent—what we call the neuroprosthetic—will go in the brain,” says Levy. “This is what our residents, fellows and even our students at the Jacobs School get to see in action: medical technology that really doesn’t exist in mainstream medicine yet. It’s part of this whole revolution in AI that’s happening right now.”

Media Contact Information

Ellen Goldbaum News Content Manager Medicine Tel: 716-645-4605 [email protected]

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Taking Teaching Further Financial Incentive: impact evaluation feasibility study

Research report for the impact evaluation feasibility study of the Taking Teaching Further financial incentive.

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Taking teaching further financial incentive: impact evaluation feasibility study.

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PDF , 320 KB , 35 pages

The Department for Education (DfE) commissioned this research to assess the feasibility of an impact evaluation of the financial incentive.

This report includes recommendations for the:

• most appropriate evaluation approach
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