how to start a medical research project

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• Ann R Coll Surg Engl
• v.94(5); 2012 Jul

How to undertake a research project and write a scientific paper

University of East Anglia,, UK

Research and publishing are essential aspects of lifelong learning in a surgical career. Many surgeons, especially those in training, ask for guidance on how they might start a simple project that may lead to a publication. This short paper offers some practical guidelines on the subject.

How to get started with a project

How to get started varies depending on whether the project is suggested by a trainer or educational supervisor. Projects suggested by a senior are always offered as an encouragement to a trainee, who should be careful not to respond in a negative way by ignoring the suggestion, coming up with a string of excuses or doing the project badly! Here are some simple steps that may contribute to an organised start on the project. You need a protocol but first you must be clear about what the project will involve.

• Undertake a literature search on the suggested topic.
• Read all the papers from the last ten years and summarise them on a single page of A4.
• Make a note of how many similar series have been produced, their size, the length of follow-up and any special aspects of the subject that have already been addressed.
• List aspects of the topic that have not been well covered, perhaps morbidity or surgery for rare indications, or long-term outcomes.
• Discuss your thoughts on the subject with your colleagues.
• With the strengths and weaknesses of the current literature clear in your own mind, summarise your thoughts in bullet points on a single side of A4 and arrange ten minutes to discuss them with the senior who suggested the topic.

The six steps listed above can be easily completed within a couple of weeks. Once you have discussed and agreed the aims of the project as well as how they can be achieved, you can write your protocol. It is also possible that having studied the literature you decide the suggested project is unlikely to add to our current knowledge and that another topic might be better studied.

A protocol and approval from your trust’s research and development (R&D) department as well as from the research ethics committee (REC) are needed before you begin a research project. If you are planning a service evaluation, REC approval may not be needed. When you have secured the approvals, the process of collecting the data begins.

Examining a case series, there may be hundreds of medical records that need to be studied and it is crucial to draw up a ‘proforma’ on which to record patient data. This should ideally fill no more than one or two sides of A4 and needs to include all the data that you have decided to collect for your particular study. It is crucial not to leave out a dataset you might later wish to look at but on the other hand it is also important not to collect too many data. Because of this fine balance, it is important to draw up a proforma and agree its composition with your supervisor and any co-workers on the project before starting to collect data from the medical records.

Data collection can be time consuming and it may be that several colleagues can work on this to speed the project along. Once all the data proformas are filled in, the data need to be entered into the database, spreadsheet or statistical package of your choice. It is best to use the software favoured by the department or colleagues in medical statistics.

Having looked at the data, discipline yourself to produce a succinct summary on one side of A4. Again, arrange a meeting with your supervisor and any other co-workers to discuss the findings, and give everyone the opportunity to comment and correct the summary. Once the findings are agreed, you are ready to write up the project.

Self-generated projects

Sometimes you will want to develop an idea of your own. It is even more important with a self-generated project to do a thorough literature search to make sure that your ideas will contribute to our knowledge. The discussion of a more ambitious project like a randomised trial should be with as many colleagues as possible, both for advice and also to garner support for your idea. Having produced a single side of A4 summarising your idea, identify a senior colleague who can advise you and proceed as described above.

As noted previously, REC approval is needed for any clinical research involving patients or their data. You will need to prepare an application on the Integrated Research Application System website ( https://www.myresearchproject.org.uk/ ). If you have never done this before, seek advice from your trust’s R&D department. REC approval is time consuming; the following comments may help:

• Much of your initial work producing a summary of your idea will be helpful in completing the ethics committee form. It is crucial that submission to your local ethics committee is checked by all your co-workers.
• Colleagues from medical statistics and any other parallel disciplines such as radiology or medical chemistry need to be involved right at the start of this formal submission so that all aspects of the study are academically correct. It is especially important to have expert statistical input because it is very demoralising to finish a trial only to be told that your study is woefully underpowered and cannot answer the question that it set out to address!
• It is wise to present your idea to the committee in person as this can save time and iron out minor misunderstandings. These ‘glitches’ in an ethics submission can soak up months of precious time and a personal meeting with the REC can help to avoid them.
• Many institutions also have research governance or internal review boards that must also pass a project after it has gained ethical approval. Their role is often to assess the financial and organisational impact of a study.

This process seldom takes less than 3 months and may take nearly 12 months. Do not be disheartened by this. If your study is worth doing, then it is worth persevering.

The recording of data using a concise proforma, entry into appropriate computer software and production of a summary of your findings are all conducted in the same way as in the first section of these guidelines.

Writing up a study

One of the most challenging aspects of surgical research is writing a paper. Putting together a manuscript for submission to a journal can be broken down into several simple and relatively self-contained steps:

• Journal guidelines : All journals have a set of instructions for potential authors. The suggestions below are an overall guide to writing a paper but should be viewed in the context of the specific guidelines on submission to the journal you have chosen for your work.
• Title : Keep this simple and concise.
• Authorship : This topic may be a source of some problems. My own observation about authorship is that if you leave somebody out who feels they have contributed to your project, you can make an enemy for life! It is easy to forget colleagues, especially when a project has run for several years. Try, within the internationally agreed authorship guidelines, to include all colleagues who have contributed significantly to your study.

The order of authorship may also cause problems. It is generally agreed that the main researcher who also produced the first draft of the paper is the first author. The second author has usually been the second main contributor to the project. The last author is the senior person supervising the work. Between these positions come all other authors who fulfil the guidelines for authorship. If in any doubt about who should or should not be in the authorship, discuss it with your senior author.

All papers have a corresponding author responsible for answering queries after submission of the manuscript. It is best if he or she is a permanent member of the department as queries may arrive several years after a paper is published.

• Abstract : This is usually 200–250 words and should be written in the style of the journal. Generally, this includes sections on background, methods, results and conclusions.
• Introduction : This should introduce the reader to the subject covered in the study and explain why this particular study has been undertaken. It should be kept to two or three paragraphs. The first paragraph sets the scene and summarises the current literature. The second paragraph should justify why this particular study or series of cases has been put together.
• Patients and methods : The most frequent mistake in this section is to include results as well as patient details. It is important to stick to describing the study population, how they were collected and, crucially, how any analyses were undertaken. Always describe what statistical tests were used and justify why they were appropriate.
• Results : These should be presented concisely with as few tables or figures as possible. Use a logical sequence and follow the same sequence in the methods and discussion sections.
• What are the main findings of your work? State clearly what you can conclude from your observations, taking care not to overestimate what you can conclude.
• Why are these findings valid (sample size, methods etc)? Explain what leads you to conclude that your findings may be relied on. Also make sure you highlight any potential weaknesses in your data and consider other potential confounding variables that might invalidate your conclusions.
• How do your observations compare with other work in the same area? Discuss how results from your work compare with other papers on the same subject, either explaining similarities or examining differences.
• Any other business? Are there any unexpected side observations that merit separate discussion? This might include unexpected complications in a trial or a unique subset of patients in a clinical series.
• Restate your main findings and suggest what further work might be helpful in providing more information on the topic of your project.
• References : Make sure these are presented in the style of the journal you have selected.

Publication of the paper

This can be the biggest hurdle you have to clear! Some basic rules will help to make this easier. First, never submit a paper without all authors having read it and agreed to the content. Second, never submit a paper to more than one journal at a time. Finally, remember that submission is not the end of your paper but just the beginning.

Selection of the right journal is important. On the basis of their impact factor, journals may be divided into four divisions. Think of it like the football league! The premier division contains journals with impact factors greater than 10, the second division those with impact factors from 5 to 10, the third division with impact factors from 1 to 5 and, finally, the fourth division with impact factors less than 1. Just as with football, journals may be promoted or relegated so it is wise to check online for a journal’s current impact factor.

Discuss with your co-workers what your target journal should be. It is acceptable to aim just higher than you think your paper ranks but obviously pointless sending a small case series to one of the premiership journals. A second consideration is which articles have appeared in your target journal over the last 12 months. If there have been one or more papers on the same subject as your work, it may be better to select an equally ranked journal that has not had a paper on your topic for several years.

Peer review is the process used by journals to select papers for publication. Many papers are rejected immediately but those deemed of potential interest are sent out for peer review. This process usually takes 3–4 months (although some journals such as the Annals of The Royal College of Surgeons of England have a much quicker turnaround). There are four potential outcomes:

• Accept without corrections – this is very rare!
• Minor corrections needed followed by resubmission for publication
• Major corrections needed and resubmission invited but without any promise to publish
• Major criticisms and rejection (for most major journals this is the single largest category of outcomes)

When you receive the reviewer’s comments don’t take them personally! The best way to regard the reviewer’s criticisms is as helpful suggestions to improve your paper. It is crucial to deal with each of the reviewer’s comments carefully, systematically and politely. If possible, respond to the comments within a few days of receiving them.

If your paper has been rejected, then the reviewer’s comments are an excellent set of suggestions to improve the manuscript for submission to another journal. This should probably be in one division lower than your first submission. Again, there is no reason to delay resubmission to another journal more than a few days. Make sure that all possible advice on rewriting and correcting your paper is taken and your work will almost certainly get published eventually!

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Industry-initiated clinical trials

The majority of clinical studies conduced at the SOM are industry-designed and -sponsored Phase 1 to Phase 3 clinical trials, with the ultimate goal of FDA product licensure.  The investigator’s role in these studies varies considerably.  Most of these studies are multicenter studies that follow a protocol developed by the sponsor with little intellectual input by the investigators.  At the other extreme are single site studies where the investigator plays a primary role in the design as well as the execution of the study.  The process associated with industry-initiated studies follows this general schema:

• Individual faculty can contact a company directly; alternately, the sponsor or its contract research organization (CRO) will inquire if an investigator wishes to participate in a planned study.
• Because company product development plans are confidential, the PI must sign a confidentiality disclosure agreement (CDA) before being sent a full protocol for consideration. If you receive a CDA, review it and forward it to SOM Grants and Contracts, which negotiates and signs such documents.
• The company will provide a protocol synopsis and a feasibility questionnaire for the faculty to review and complete.
• The company may conduct a preliminary site visit or hold an investigator’s meeting to discuss the project in greater depth.
• The PI must submit the protocol for review and approval by the IRB. If the research is being performed under the auspices of the UVA Cancer Center, its review committee must approve, as well. Please note that a clinical trials agreement with the sponsor may not be signed and recruitment and clinical activities cannot take place prior to IRB approval.
• The sponsor will ask the PI to complete an FDA form 1572 (statement of investigator). By signing this form, the investigator assumes responsibility for all aspects of the conduct of the study at the UVa site. In most cases the sponsor will present a completed form, along with a financial disclosure statement, to the investigator for signature.
• The clinical trials agreement is a binding contract defining the study to be undertaken, remuneration, reporting, intellectual property, confidentiality, publication rights, etc. The Office of Grants and Contracts signs these agreements and can provide a sample agreement. The F&A rate on clinical trials is 25% of total direct costs.
• Representatives of the sponsor hold a study initiation meeting with the PI and his/her team to walk through the study protocol prior to initiation of recruitment. This ensures that the latest, approved versions of protocols, consent forms, and case report forms are understood and used appropriately by all parties.
• Study initiation, conduct, and close-out.

Investigator-initiated clinical research

Initiating one’s own clinical research project provides greater flexibility but comes with greater responsibilities.  A brief outline of these, with resources for help on each, follows:

• Funding. NIH and the corporate sector support investigator-initiated protocols. Many clinical research studies can be funded by routine K- or R-series awards. There are special considerations, however, for studies that are defined as clinical trials (see NIH definition ). Some NIH Institutes and Centers fund Clinical Trial Planning Grants (R34) to prepare for Phase III trials. Full trials are funded via a different mechanism, such as a clinical U01. Institutes have varying policies on the investigator-initiated research they will accept. See, for example, NHLBI  and NIAID web sites on clinical awards. Industry supports investigator-initiated projects that are in concert with the existing development pathway for one of their products or that test innovative uses of an existing drug.
• Intellectual property. Inventions generated in the course of an investigator-initiated trial are the property of the University and subject to its Patent Policy.
• IND Application and reports to FDA. If the trial involves the administration or implantation of a drug, biologic, or device in a manner or for an indication that is not FDA approved, the PI may have to file and maintain an Investigational New Drug (IND) or Investigational Device Exemption Application (IDE) with the FDA. The Clinical Research Office can assist with assessing the need for an IND/IDE. The faculty sponsor of an IND/IDE is responsible for meeting all monitoring and reporting to the FDA on all studies initiated under that approval. For faculty who sponsor studies at sites other than UVa, the Clinical Research Office can assist with monitoring services at remote sites. The cost of this monitoring must be included in your study budget.
• Publication of the protocol on a public web site. The University requires that corporate sponsors of research contracts publish their clinical trials on a public site such as ClinicalTrials.gov (as does NIH, for trials under its support).  Furthermore, U.S. Public Law 110-85 requires that the sponsor of an IND/IDE or PI register all trials of drugs and biologics subject to FDA regulation (other than Phase 1) and trials of devices (except for small feasibility and pediatric postmarket surveillance) and post information on results of those trials.  The Clinical Research Office can assist with posting a study on ClinicalTrials.gov .  Finally, the International Committee of Medical Journal Editors has mandated that all Phase 1 clinical trials published in their journals must be registered at a public site.
• Source of study drug, if an unlicensed product. The mode of manufacture, testing for purity/adherence to specifications, and packaging of drugs, biologics, or devices must be described in the IND/IDE Application.  These generally are performed under Good Manufacturing Practice (GMP), often by an outside contractor.
• Project management. The PI must develop a Manual of Procedures, study documents (protocol, consent, case report forms), Data Safety Monitoring Committee, reporting procedures for adverse events, etc. These administrative requirements vary depending on whether the clinical research meets the definition of a clinical trial and are even more demanding for multi-center clinical research projects, where several PIs, clinical research coordinators, and IRBs are involved.

Responsibilities in clinical research

The principal investigator is responsible for:.

• assuring that the study budget is adequate for the planned studies, including required payments to the Medical Center and providers of the various clinical services;
• obtaining IRB approval of the study protocol prior to initiating research, and any subsequent modifications to the study protocol or forms before initiating any changes in study procedures;
• submitting required progress and adverse event reports to the IRB;
• ensuring that all members of the research team follow Good Clinical Practice (see below) and comply with IRB requirements;
• compliance with federal regulations such as HIPAA, use of hazardous materials, etc.;
• assuring that clinical charges are billed appropriately to third party payors as standard of care or to the study funds as research;
• notifying the IRB and UVA Conflicts of Interest (COI) Committee of existing financial COIs and newly-occurring COIs through the end of the study.

Clinical research coordinators are responsible for:

• managing the conduct of clinical trials, under the direction of the PI;
• maintaining in-depth knowledge of protocol requirements and Good Clinical Practice as set forth by federal regulations;
• sound conduct of the clinical trial per protocol, from recruitment through follow-up;
• meticulous maintenance of accurate and complete documentation (e.g., regulatory documents, signed consent forms, IRB approvals, source documents, drug dispensing and subject logs, and study-related communication);
• organizational management of the trial (e.g., timeliness in completing case report forms, data entry, reporting adverse events [AEs], and managing caseload and study files);
• communication of protocol-related problems to all study staff and PI (e.g., questions regarding the conduct of the clinical trial, possible AEs, or subject compliance);
• professional conduct in the presence of subjects, research staff, sponsors, monitors, auditors, etc.

Preparing budgets and billing for clinical trials

The investigator must recover all study costs.  Rarely, due to the scientific importance of a particular study and the existence of local funds to make up the shortfall , an investigator may choose to participate at a financial loss.  The Clinical Research Office can assist in the development of study budgets.  Its personnel have access to current hospital laboratory charges and knowledge of a variety of costs that may not initially be apparent to new PIs.  See their guidance on budgeting for a clinical trial .

The PI must ensure that all billing for costs incurred in the conduct of clinical studies is appropriate and in compliance with relevant laws and regulations.  Clinical protocols may include both standard-of-care and experimental activities (i.e., not medically necessary or known to be effective).  Standard-of-care procedures may be billed to government or private insurers or to the subject, except when the sponsor has agreed to cover those costs.  In general, activities that are purely experimental may not be billed to Medicare, Medicaid, other third party insurers, or the research subject:  these are the responsibility of the sponsor.  (Rarely, per law or regulation, costs for experimental activities required for a clinical trial may be billed to a third party or to the subject, if they are not reimbursed by the sponsor.)

The Clinical Research Office provides assistance with development of a billing plan delineating which study procedures and interventions are standard-of-care vs. investigational, and who (sponsor, insurer, patient) will be financially responsible for each.  In addition, the CTO can assist with properly budgeting for those interventions that will be billed to the study budget.

Development and submission of human use protocols to the IRB

Protocols are submitted to the IRBs via an  on-line system .  The IRB offers help in protocol development, either directly or through IRB support personnel in the various clinical departments of the School of Medicine.

Training for investigators and clinical research coordinators (CRCs)

The Clinical Research Office conducts  continuing education programs for both clinical investigators and CRCs, including an annual series, “brown bag” sessions, mentoring of CRCs , and link to the NIH Clinical Center’s video series, “Introduction to Principles and Practices of Clinical Research.”

Hiring clinical research staff

CRCs and clinical research managers are hired through UVA Human Resources , in the “Health Care Compliance Specialist/Manager” or “Registered Nurse (Inpatient Research)” series, with the assistance of their department HR representative.  These positions are described at the HR Web site .

Pharmacy services

The Medical Center’s Investigational Drug Service supports clinical research research (including randomization, blinding, preparation of placebos, storage and inventory of medications, etc.).  These services are provided at cost to the investigator.

Biostatistical support

The Division of Biostatistics & Epidemiology (Dept. of Public Health Sciences) can help with study design, development of analytic plans, and analysis of pilot and clinical study data.  Contact Dr. Jae Lee (982-1033, [email protected] ) for additional information.  The Division also has posted on its Web site a request for biostatistical services form .

Accessing SOM/UVA research core facilities

SOM core facilities provide subsidized services at reasonable cost to University users; for clinical investigators, these might include flow cytometry, DNA sequencing, or the biorepository and tissue research facility.  Certain research centers and complex NIH research awards provide additional cores to support patient-oriented research.

Recruiting research subjects

UVA IRBs conform to federal restrictions on what can be included in advertisements.

Quality assurance (QA) and monitoring activities

QA includes the development and maintenance of Standard Operating Procedures (SOPs) for clinical trials, training of clinical research personnel in study methods and regulatory compliance, and assistance in preparing for FDA, sponsor, or internal audits.  Monitoring includes the following:  tracking of patient accrual; assessment of patient eligibility and evaluability (e.g., completeness and accuracy of study records); reporting of adverse events to IRB and other investigators (PI/CRC responsibility); and interim evaluation of outcome measures and patient safety information (often conducted by an independent Data Safety Monitoring Committee).  The majority of these functions are provided by the ClinicalResearch Office to ensure quality of study results, protect subject safety, and to maintain statutory and regulatory compliance.

Environmental health and safety

Use of recombinant DNA or pathogens in clinical research or handling of patient/subject specimens outside of the Medical Center clinical laboratories requires approval of the Institutional Biosafety Committee.  Use of biological, chemical, or radioactive hazards in clinical research is overseen by, and requires training administered by and approval of the Office of Environmental Health and Safety .

Responsible conduct of research

In order to ensure that the public can trust research performed by UVA investigators, the highest standards must be maintained by its faculty and staff.  See a broader discussion of this topic on this site.

• Good Clinical Practice (GCP). GCP is a broad set of practices required by regulatory agencies (e.g., the FDA and the International Conference on Harmonisation ) to ensure the quality clinical trials data that serve as the basis for licensure of drugs, biologics, and devices. These guidelines include such activities as IRB procedures, minimizing risks to research subjects, investigator and sponsor qualifications and responsibilities, recordkeeping, and so on.
• Authorship and data integrity policies. Refer to the SOM policy on authorship and to the UVA Research Misconduct Policy , which covers data integrity.
• Conflict of interest (COI). Clinical investigators should carefully avoid the appearance of conflict of interest (COI) because of the participation of research subjects and the potential impact of this research on patient care or health policy. Financial interests of study staff or their families must not influence, or appear to influence, the design, conduct or reporting of any clinical research. When submitting a protocol to the IRB or a clinical research proposal to the Office of Grants and Contracts, the PI should notify these offices of any potential financial conflict. Refer to this more detailed description of COI policy and procedures.
• Incentive payments. UVA SOM employees may not accept the following types of incentive payments in the conduct of clinical trials (see SOM Policy, ” Payments for Referring or Enrolling Patients in Clinical Trials “): time/enrollment incentives (bonus for enrollment by a certain date); milestone-based incentives (payment when all forms have been submitted); or enrollment-based incentives (payment for a specific number of patients, rather than flat per-patient remuneration).

Navigating regulatory compliance requirements at UVA

Several committees and offices are charged with compliance oversight of clinical research.  In many cases the review process is sequential, with action by one office contingent on prior approval by another.  The process can be most efficiently navigated as follows:

1.  General requirements that are not protocol-specific:

• Hiring a study coordinator.  A well-trained study coordinator is not required for the conduct of clinical research but is strongly recommended.  The requirements for regulatory compliance for human subjects research are complex and evolving.  A study coordinator can help assure that these requirements are met and appropriate documentation is maintained.  The Clinical Research Office can provide on-site mentoring of study coordinators.
• IRB training.  All study personnel who will have access to human subjects or to research data from identifiable human subjects must complete the on-line  IRB training modules , which may take several hours to complete.  This training must be completed before the IRB will approve a study.  Incoming faculty may complete this training before arriving at UVA, to expedite subsequent protocol submission.
• Institutional Biosafety Committee training.  For studies that will collect or handle specimens from human subjects outside the clinical areas of the Medical Center, faculty and staff must complete appropriate IBC training for bloodborne pathogens .  Bloodborne pathogens training for health care personnel provided by the Medical Center is not a substitute for the IBC training module.  If biohazardous substances will be shipped, the individual(s) responsible must complete a specific training program on shipping infectious substances .

2.  Once the protocol has been developed:

• Budgeting.  The investigator is responsible for assuring that the budget is sufficient to fund all study related expenses.  Budgets involving patients who may also be receiving non-research related care in the Medical Center or that involve purchase of clinical services from the Medical Center can be particularly challenging.  Physician providers cannot negotiate charges for Medical Center procedures .  Charges for Medical Center services will be billed to the study, based on a fixed formula for the cost of the service.  The Clinical Research Office  can help generate an appropriate budget for these services.  The PI must also assure the differentiation of standard of care charges (that may be legally charged to third party payors) from study charges that must be funded by the sponsor.  The Clinical Research Office can also assist with this aspect of budgeting.
• Initiation of the study agreement for industry sponsors.  SOM Grants and Contracts will not sign a study agreement without IRB approval.  Negotiating the agreement can be quite time consuming, so it is prudent to start this process early.  Initiation of this process requires that you submit a Proposal Approval Sheet , via your department administration, to Grants and Contracts. Although not all the information requested on the form will be known at this point, complete as much as possible.  Your Chair’s countersignature on this form indicates his or her commitment to the time and space required to perform the study.  The PI also must submit a Conflict of Interest Disclosure form and a Drug Study Questionnaire , if required.
• IBC registration.  Your specific protocol must be registered with the IBC if specimens from human subjects will be handled in areas other than designated clinical space (see https://ehs.virginia.edu/Biosafety-IBC.html ).  The IRB will not approve a study until the PI has received an approved registration from the IBC.
• Assessment of the need for an IND/IDE.  If the sponsor does not already have an IND/IDE or if the study is investigator-initiated, an investigator-initiated IND/IDE will be required if the study uses a drug or device that is not already approved by the FDA or an FDA-approved drug or device in a manner in any way different from its approved use.  The Clinical Research Office can help assess the need for an IND/IDE.

3.  Navigating the review committees:

• Cancer trials.  If the study involves cancer patients, it must be reviewed by the Cancer Center Protocol Review Committee before submission to either the GCRC (if applicable) or the IRB.  The committee meets monthly and the protocol must be submitted at least three weeks before the next scheduled meeting.  See Protocol Review Committee guidance .
• IRB review.  Studies involving human subjects must be approved by the IRB.  Protocols must be submitted on forms generated by the IRB Protocol Builder.  See IRB guidance .  The protocol must be submitted for pre-review at least 5 days before the full submission deadline.  IRB meetings are scheduled every two weeks; submission deadlines are approximately 8 days prior to each meeting.

4.  Once you have IRB approval:

• Submit the signed IRB approval (Form 310) to Grants and Contracts to allow the study agreement to be signed.
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How to Write and Publish Clinical Research in Medical School

From working hard on the USMLE® exams to holding leadership positions in a specialty’s academic society, there are many ways medical students can work towards matching into the residency of their choice. One such activity that looks great on residency applications is finding clinical research opportunities in medical school to write and publish papers. No one knows this better than Dr. Eve Bowers. 

An Otolaryngology resident at the University of Miami/Jackson Memorial Hospital, Eve became an expert in writing, submitting, and publishing manuscripts during her final years in medical school. Check out Eve’s blog post below to get valuable insights on how to get published in medical school. 

As medical students, we’re told that research is important and that publications are “good”, and even “necessary to match ” into residency, but we often aren’t given the tools we need to turn ideas into manuscripts. This is especially true given our rigorous schedules. 

When I looked through my CV, I saw I had a few abstracts and presentations, but no manuscripts. I wanted to write, but publishing seemed like just checking another resume box. On top of that, I didn’t know where to begin. 

My writing journey started with a case report I nervously picked up during my surgery clerkship . Then, over ten months of typing, editing, and sending unanswered emails, I went from writing 0 to ten manuscripts. The process was sometimes painful but mostly gratifying (yes, research can be gratifying), and you can do it, too.

To make finding, starting, and publishing high-quality research articles a little bit easier and a lot more enjoyable, check out my five tips for publishing clinical research in medical school.

1. Build your network to find publication opportunities in medical school

When looking for projects, finding great mentors is often more useful than finding the perfect project. This is especially true when starting out. Use your time on clerkships to identify attending and resident mentors who you trust to support your budding author ambitions.

At this stage, residents especially are your friends . When you demonstrate follow-through and receptiveness to feedback, you will be given more research opportunities. Don’t be shy about asking mentors for tasks if you can juggle multiple projects, but don’t bite off more than you can chew. It’s important to communicate honestly and be transparent about the amount of time you have.

2. Kickstarting your research during medical school: start small 

If you have no research experience, start with a case report. Volunteer to write an article about an interesting case you saw in the operating room or clinic. It’s much easier and more rewarding to write about patients you have experience with, and case reports are a great way to demonstrate your writing ability to more senior authors.

Pro tip : Try to figure out as much as you can independently by using published reports as blueprints before asking for help. Nevertheless, don’t be afraid to seek guidance when you need it! If you approach a mentor with a problem, come prepared with 2-3 realistic solutions or examples of how you tried to figure it out on your own.

3. Know the criteria for writing a clinical research paper 

Before you begin, ask your mentor where they would like to submit the completed work. Each journal has specific standards, styles, and submission criteria. For guidance, look to papers previously published in that journal. 

As far as annotations and citations are concerned, download and learn how to use Endnote or Zotero right now! You’ll save days of work formatting your references.

Additionally, consider creating folders and spreadsheets to keep track of projects. Set goals and timelines for yourself from the beginning, and block off dedicated time to conduct a literature review, analyze data, and write.

Pro tip : If you are the first author and overseeing a large team, improve communication and efficiency by making everyone’s roles and expectations very clear to the group via email.

4. Follow up with your mentor

Sometimes you’ll send your mentor a draft, but she won’t get back to you with edits and feedback in a reasonable timeframe. Surprisingly, many projects do not get past this point because of insufficient persistence. Here’s what to do if this happens:

• Politely nudge your mentor with follow-up emails and schedule a meeting to discuss in person or via Zoom.
• Set deadlines and give specific reasons why the paper needs to be submitted. Some reasons could include, “I need this submission for my residency application ” or “this is a requirement for my school.”
• Ask your co-author resident and/or fellow to advocate for edits and submission.

Whatever happens, don’t give up at this point. You’ve put in the work, and persistence makes or breaks a successful student-author.

5. Write about the medical topics that you love

Writing is fun when you focus on subjects you’re really passionate about. You also don’t have to stay within your institution: feel free to branch out if you come across an interesting research opportunity at a different program. A little cold email can go a long way!

If your goal is quantity, you can increase output by asking around about “productive” research mentors and sticking to topics related to clinical practice or medical education. However, my advice is to never let relatively quick publication opportunities compromise the quality of your work. Remember — every paper you write gets easier and more enjoyable, and your work will be truly important to advancing the field you care about. Good luck!

About the Author : Eve is an Otolaryngology Resident at the University of Miami/Jackson Memorial Hospital. She attended medical school at the University of Pittsburgh School of Medicine and undergrad at the University of Pennsylvania. She is passionate about medical education, mentorship, and increasing minority and female leadership in surgical fields. For more tips and tricks, follow her on Twitter and Instagram !

For more information on residency applications, check out the AMBOSS Residency Applications Clerkship Survival Guide. 

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Comprehensive Guide to Research from the Perspective of a Medical Student

• By Dmitry Zavlin, M.D.
• February 9, 2017
• Medical Student , Pre-med

G uest post from Dmitry Zavlin, MD, a research fellow in Houston, Texas. He has been highly productive in his research endeavors and below describes a comprehensive guide to getting involved in research.

Without any doubt whatsoever, high USMLE scores, strong recommendation letters from faculty members, a multitude of away rotations, and an updated and accurate résumé make up the foundation of a strong application for a residency position. Nevertheless, from my personal experience, one topic remains crucial that many medical students either love or hate (or try not to think about it): research . It is an extracurricular activity that enables someone to stand out from the crowd and present oneself as a diverse and multitasking character. These traits are especially favorable when it comes to applying to competitive residency programs with high applicant to position ratios. I encourage every future graduate to look into this topic since – and as astonishing as this may seem – medical school is the ideal opportunity to get your name out there. You don’t need to take a year off from classes or be on an M.D., Ph.D. track. Even those students that do not seek academic careers have a benefit from engaging in scientific duties . It helps you understand the mechanisms of research, the bureaucratic obstacles, the medical challenges, and teaches you communication with peers and faculty. Furthermore, you learn how to read, analyze, and interpret scientific publications of others. And trust me, it’s not all gold that gets printed in journals . On first glance, getting involved in unpaid ventures while you are in class, on rotation, at home studying or just taking some time off for yourself might seem like a bad deal. Yet with a sincere approach towards this subject, you can strengthen your résumé, top off your application, and learn skills that will serve you well into your career as a doctor.

The following lines are intended to display my personal experience that I have made at my medical school and in my interactions with students, residents, fellows, and attendings at my current position.

Choosing your Project

First things first. Naturally, you would want to participate and conduct research in a field of medicine you might see yourself in after graduation. However, as mentioned before, this is not a K.O. criterion. Plenty of personal experiences tell me stories of students who were involved in one area and then switched and matched in a completely different specialty of medicine or completely left the patient-care sector. Therefore, consider your engagement in scientific tasks more of as a symbolization for your work ethic and your ability to perform in a team.

My first tip is to contact the department at your home medical school, introduce yourself, write 1-2 sentences describing your motivations and goals, and ask to sit down with some faculty members or scientific staff to discuss your involvement in any research activities.

Larger departments usually have secretaries or an academic office where your email is less likely to get lost compared to the inbox of a busy professor who receives hundreds of emails per day. Personally, I would aim for junior faculty and potentially senior residents who are experienced enough to conduct research on a high level but are not too far away from the life of a young medical student. Certain departments further have specific full-time research staff that is definitely a great resource for any scientific venture. While it may be helpful to work with the director and senior faculty directly, the sad reality is often that they typically have many academic and administrative duties and activities at their institutions that might not go along well with the schedule of an ambitious student and cause frustration in the long run.

When you meet, make sure to gain and write down as many details as possible:

• What is the topic, what is the goal of this project?
• What type of format is it? (See below)
• What is the current status?
• Who is involved in this research project, what is the team, what are the people to contact?
• What will be my duties?
• Any bureaucratic issues to be aware of (IRB approval, grants, finances)?
• What is the prognosis? Are there any deadlines?

Lastly, ask about the current literature on that topic so you know what your team’s role is going to be in this scientific field. Although one core concept of any research result is reproducibility, it often remains a challenge to publish a project that has already been performed and presented or printed before. Getting involved in an area that is in quick development with high turnaround is subsequently a strong recommendation.

Types of Evidence-Based Research

Now, I would like to talk about the most common options you will encounter when presented with an array of project offers. That way you know their perks and pitfalls before you commit to anything serious and long-lasting and potentially even waste any valuable and limited time of yours.

• Case Reports: These are the most basic and least powerful of scientific contributions to medicine. Give or take, a case report is the summarized hospital or clinic chart of a treated patient who presented with a problem A and was managed with therapy B. A case report that is typically 2-3 pages long with a short intro, a compact case discussion, and perhaps some photos is the closest thing you will get to a patient note you learned to write in early medical school. Their lack of medical value makes them hard to get published in journals and students should not solely rely on these projects as they may not ultimately be accepted by journals. Recommendation: 3/5
• Case Series, Retrospective Study: These layouts are my personal recommendation as they allow quality results within a short period and are not time-consuming or require large long-term commitment as others. Typical examples are an analysis of patients who presented with the same diagnosis or underwent an identical procedure. The difference between a case series and a retrospective study is that for the latter, the patients can be stratified into different subgroups (similar to “case control study”) and statistical calculations can be performed to achieve significant conclusions. Recommendation: 5/5
• Prospective Studies: In these studies, patients are gathered in one or multiple cohorts and are followed-up over long periods of time by lab results, imaging, physical exams etc. These require great time commitment and, from a student perspective, typically only allow a certain amount of participation. These are usually studies for physicians with long relationships with their patients. Recommendation: 3/5
• (Randomized) Clinical Trials : The peak of evidence-based medical research. Similar as prospective studies yet require more planning, IRB approval, and lots of work with industry, grants, protocols, etc. Student involvement is usually marginal. Recommendation: 2/5
• Basic Science, Animal Work: Although these projects require training, approval, and a large amount of preparation, student participation is common in many areas of basic science. The advantage of these laboratory activities is a certain amount of flexibility on when certain tasks and duties can be performed. Within certain limitations, a medical student can get involved in animal or basic science research and assist in specific jobs suitable to his or her personal schedule. Even partial involvement can be enough to get one’s name on a publication. However, lab work can be monotonous and frustrating at times when experiments do not deliver the anticipated results. Sitting in non-stimulation laboratories requires a certain type of character. Recommendation: 4/5
• Descriptions of Innovations: Purely descriptive publications of new surgical techniques, innovative technology, new pharmaceutical drugs, or simply personal statements on evolving subjects, etc. This type of work often demands a given level of expertise and is not typically suitable for graduate research. Recommendation: 2/5
• Reviews, Meta-Analyses: These types of written compositions are based on a literature review. The author’s job is to read through countless, often hundreds of previous publications and create a summary regarding a specific medical topic. Reviews and meta-analysis are particularly useful for issues that are prevalent and have delivered many reports in the past. Whereas a review merely lists the findings of previous research groups, a meta-analysis is able to pool data and conduct statistical analyses. These projects allow great flexibility and can be finished from any location but do not underestimate the time needed to achieve proper results. Recommendation: 4/5

Formats of Publication

What follows is a list of mediums that allow you to get your work to the public. Albeit the concept of most research activities is similar and progresses on akin paths, it is important to agree on a goal early in the research process. Journal articles, for example need to be of highest quality and impeccable when submitted. Presentations must be tailored accordingly depending on what audience you are planning to address. Book chapters need clear guidelines to ensure that your handiwork fits well to the other parts of the volume. Make sure to discuss this topic with your seniors to understand their expectations from you.

• Journal Articles: These are the highest quality format that you can use to submit your research work for the world to see. Upon arrival at the journal’s office, the editorial office first reviews your manuscript and determines its eligibility. Next, it is sent off to a number of anonymous reviewers who judge your documents and suggest if it is worth publication, if it needs changes, or if it should be rejected. Being an author on articles in peer-reviewed journal is the strongest support to improve your application. Recommendation: 5/5
• Podium Presentations: These are typically 5-15min PowerPoint conferences or similar in front of regional, national, and international audiences of students, residents, nurses, scientists, and board-certified physicians. While your work might be less accessible to the world than published articles, it is still recommended to submit your accomplishments to such conventions. Aim for national conferences rather than regional ones. Recommendation: 4/5 for (inter)national, 3/5 for regional conferences
• Poster Presentations: A classic poster session is where you travel to a conference, hang your poster with a summary of your research findings (similar to a short abstract) and are available for others to review your work and ask questions. In some cases, poster sessions are requested by conferences when you apply for podium presentations but your projects are not considered beneficial enough. Recommendation: 3/5
• Book Chapters: Senior physicians, faculty members, or experts on a certain field are sometimes asked to write segments of medical or scientific books that are soon to be brought on sale to the market. In certain cases, students or residents write segments of such book chapters for the senior author. From personal experience, these projects are a long-term process as they go into extreme medical detail. On the upside, publication with your name on it is almost guaranteed. Unfortunately, these types of publications are not of high evidence-based research and should only be considered as a secondary side project Recommendation: 3/5

Basic and Necessary Know-How

After choosing your project you need to learn and understand how the scientific process works once you have your results ready for publication. Conducting the studies, experiments, and the literature reviews is one part of the research job. Presenting your findings is the other side of the coin. Read many publications on the same subject and study what a paper is supposed to look like. Analyze the language the authors use. It has to be straight to the point, factual, objective, leave out unnecessary information yet avoid long soporific segments of repeating details. Your audience will want to hear a hypothesis, the methodology of your venture on how said hypothesis should be tested, your results, and an antiseptic interpretation thereof. Having a senior writer review your work is therefore crucial in the beginnings of a research career.

Next, and this may seem like a no-brainer, learn how to properly and efficiently use today’s available technology to your advantage. Learn the most important features of your word processing software. Get access to a tool that allows to sort and list literature references and full versions of articles, preferably in PDF format. If you share files with others or work simultaneously at different sites, use a cloud service to keep your files in synchronization across all your devices. Any photo, video, or graph-editing software with some artistic skills might come in handy as well. Lastly, learn some basic mathematical and statistical skills and obtain a statistical software. Research is nothing if you cannot back up your story by some hard numbers. Study what a t-test, a type I error, and a type II error are and how they work. Understand when you have to use chi-square and when the Fisher’s exact test . This list goes on and on. You do not need a Ph.D. degree in biometrics or stochastic calculus to be involved in medical research but even basic skills can set you far ahead of others and you will stand out from the crowd. Additionally, all these things I just mentioned facilitate your projects by incredible amounts and allow you to publish your results faster. Capitalize on the technology that is available today!

Finally, learn how to revise current literature and how to look for references to back up your ideas or contrast your data to those of other groups. In the end, research is a competition almost like any other business sector; except that money is not necessarily the number one objective but rather prestige and impact.  Pubmed is a valuable search engine, for instance, that allows you to go through the MEDLINE database and find similar publications to your project. UpToDate is a practical tool that is constantly refreshed by countless experts and gives access to the latest guidelines on specific topics. One of my former attendings always said that publishing a paper is like selling a car: you have to know the market and emphasize the upsides of your work to gain interest of others. Have all these files clean and tide on your computer from day 1, so you can keep a good overview of things and track your progress.

Further Aspects to Consider

When you start a new research project, figure out who your team is that you will be working with as this will determine the authors and their order on a potential publication. Make sure your name appears on the final manuscript if you have brought significant effort and input towards the project. As the New England Journal of Medicine, one of the largest and most prestigious journals in the field, states:

“Credit for authorship requires (a) substantial contributions to the conception and design; or the acquisition, analysis, or interpretation of the data, (b) the drafting of the article or critical revision for important intellectual content, (c) final approval of the version to be published, and (d) agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the article are appropriately investigated and resolved.”

The more work you put in, the further your name should appear up front. The final position of a scientific publication is usually reserved for the senior author (principal investigator) and the head of the team.

The last issue that needs to be mentioned here are finances. Even if you are working on a retrospective study and are just simply scrolling through patient charts to gather data, special software, travel to conferences, fees for journals (author processing charge for open access) can rapidly add up. Basic science ventures may require additional funding. Knowing your resources is crucial for any research. The discussion of money may seem like a sensitive subject and “above your pay grade” yet I recommend approaching this topic with open cards when the right moment comes.

Final Words

Despite the downsides of scientific work, I still believe the majority of students should experience the art of research that has made medicine what it is now. Yes, research is frequently frustrating and consumes many of your physical and mental resources. Yes, a majority of jobs after residency do not include research. Still, I will never forget the great feeling of my first accepted publication and when I immediately continued to strive towards the next challenge. Henceforward, research had something rewarding and appealing about it. In the long run, this highly dynamic profession is probably not suited for all future physicians, yet I can only repeat myself and encourage everyone to give it a try.

Dmitry Zavlin graduated with an M.D. from the Technical University of Munich in 2015.

He currently works as a research fellow in Houston.

To contact the author, please visit www.zavlin.com

Dmitry Zavlin, M.D.

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Awesome summary, really helpful for me as a med student!

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