ibm research studies

Inclusion Body Myositis – Clinical Trials

Clinical trials for inclusion body myositis are research studies that investigate the effectiveness of new treatments, medical tests, or devices. Trials are carefully designed and follow strict procedures to help provide reliable results.

Clinical Trials – General Considerations

• Phase I : Initial studies of new drugs in humans are small, short studies designed primarily to see if the medication is safe.
• Phase II : If a medication seems safe, a larger and longer study will be done to begin to learn if the drug actually works, and to obtain more safety data. Sometimes studies are designated as either Phase IIa or Phase IIb. Phase IIa studies are more exploratory in nature. Although they are designed to reveal information about the efficacy of the drug, the primary endpoint may be to determine the optimal frequency of dosing, the type of patient most suitable for future testing, or other aspects of safety and efficacy. Phase IIb studies are more advanced, and are generally designed with efficacy as the primary endpoint.
• Phase III : The final phase involves research studies of large groups of patients.

Clinical trials for Rare Diseases are Challenging:

• It can be difficult to recruit adequate numbers of patients.
• Clinical trials are expensive, and funding can be hard to obtain.
• The natural history of the disease may be poorly known.

Natural History Studies

The natural history of a chronic disease refers to how the disease affects people, from the time the disease begins until the patient dies, without treatment. Accurate knowledge of how the disease progresses is crucial to the design and implementation of clinical trials. How do you test if a drug works if you don’t know what happens in the disease without the drug? Cure IBM encourages all inclusion body myositis patients to participate in natural history studies.

All eligible people with inclusion body myositis are urged to participate in the INSPIRE-IBM study , a large natural history study that is currently recruiting new participants. Study sites are located throughout the United States. Please visit the ClinicalTrials.gov webpage for more information.

The ClinicalTrials.gov online registry

ClinicalTrials.gov is an online registry of clinical trials, and is the place to go if you would like to search for clinical trials for inclusion body myositis. The site is managed by the United States National Library of Medicine and the National Institutes of Health. Although it is a US government website, some studies offered outside the United States are listed on the website. After entering inclusion body myositis as the name of the condition/disease, clicking the “Search all studies” button will bring up a list not only of active studies that are currently recruiting new patients, but also recently concluded studies and studies which are about to begin.

Inclusion Body Myositis Clinical Trials of Current Interest

A Phase 2/3 clinical trial of ABC008, made by Abcuro, is currently underway. ABC008 is an antibody designed to attack highly cytotoxic T cells, a type of white blood cell that is present in the muscles of people with inclusion body myositis. These highly cytotoxic T cells may be responsible for much of the muscle damage in IBM. The treatment is selective, destroying most of the highly cytotoxic T cells without causing significant harm to other types of T cells or other white blood cells.

ABC008 clinical trial information at ClinicalTrials.gov

Sirolimus, also known as rapamycin, is an established, FDA-approved drug that has been used for many years to prevent kidney transplant rejection. A Phase IIb clinical trial of sirolimus in inclusion body myositis was completed in France, and results were reported in 2017. The results were promising enough to spur interest in further study. A Phase III trial is now underway in Australia and the United States.

Cure IBM Blog article on Rapamycin and Inclusion Body Myositis .

Sirolimus clinical trial information at ClinicalTrials.gov

Arimoclomol

The clinical trial of Arimoclomol, a drug which helps with protein folding and clumping, did not demonstrate a benefit in inclusion body myositis.

Cure IBM blog article:  Arimoclomol trial results for inclusion body myositis

Academic, medical journal article: A Randomized, Double-Blind, Placebo-Controlled Study of Arimoclomol in Patients with Inclusion Body Myositis

by Kevin Dooley, MD

Revised July 7, 2023

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Success Across Cultures

Understand and minimize cross-cultural issues

Hofstede and IBM: the Beginning of Significant Cross-Cultural Research

Posted on 10. May 2019 2 Comments

If you looked at Geert Hofstede ‘s life, there was nothing particularly remarkable that might make you imagine he’d one day be at the forefront of cross-cultural research.

The Dutch researcher called the Netherlands home. He lived and studied there, after which he entered the military.

He became a management trainer at IBM, as well as the manager of staff research. It was in the latter role that he became entrenched in systematic research which would later hone in on the field of cross-cultural studies.

International Employee Opinion Research Program

In his role as manager of staff research, IBM’s International Employee Opinion Research Program became Hofstede’s brainchild.

Hofstede and his colleagues gathered and analyzed over 116,000 survey questionnaires over six years. The questionnaires were collected from 72 countries and involved 183 questions about the work environment , completed by IBM employees.

Providing a number of options, questionnaires asked employees to choose which option was the most important to them.

An example:

Which is most important to you?

• A job that allows personal/family time
• Challenging work that provides a sense of accomplishment
• Freedom to adapt your approach to work

Employees could choose their preference and, although the word “culture” wasn’t used in any context by IBM staff, and they weren’t charged with researching cross-cultural differences, nevertheless, the data revealed various patterns of cultural opinion and behavior.

Still, no cultural opinions were drawn from the data at the time.

Hofstede’s Findings

Taking a sabbatical from IBM, Hofstede taught at the IMD in Switzerland.  It was there that he was allowed the time and academic engagement to analyze the IBM research.

He found that nationality could account for the behavioral differences resultant in the survey.

In order to test his theory, he questioned folks from various countries who didn’t work for IBM.

It became clear that cultural differences were there. 

The value of Hofstede’s research was lost on many for a while…it was lost even on him.

He had no idea what a significant gold mine he’d come across, from the standpoint of international business.

At the time, economic success was not dependent on cultural sensitivities . The United States was the number one unchallenged economic power.

As to the matter, Hofstede said:

“In the 1970s I was living in Brussels when I started developing my ideas of culture and I approached the European Commission about this, but found myself initially directed to an official who was responsible for museums! Such was their idea of culture!”

But all this changed in the ‘80s and beyond – a period which we’ll talk more about next week.

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very interesting read

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All press releases

IBM Study: Security Response Planning on the Rise, But Containing Attacks Remains an Issue

CAMBRIDGE, Mass. , June 30, 2020 / PRNewswire / -- IBM (NYSE:  IBM ) Security today announced the results of a global report examining businesses' effectiveness in preparing for and responding to cyberattacks. While organizations surveyed have slowly improved in their ability to plan for, detect and respond to cyberattacks over the past five years, their ability to contain an attack has declined by 13% during this same period. The global survey conducted by Ponemon Institute and sponsored by IBM Security found that respondents' security response efforts were hindered by the use of too many security tools, as well as a lack of specific playbooks for common attack types.

While security response planning is slowly improving, the vast majority of organizations surveyed (74%) are still reporting that their plans are either ad-hoc, applied inconsistently, or that they have no plans at all. This lack of planning can impact the cost of security incidents, as companies that have incident response teams and extensively test their incident response plans spend an average of $1.2 million less on data breaches than those who have both of these cost-saving factors in place. 1

The key findings of those surveyed from the fifth annual Cyber Resilient Organization Report include:

• Slowly Improving:  More surveyed organizations have adopted formal, enterprise-wide security response plans over the past 5 years of the study; growing from 18% of respondents in 2015, to 26% in this year's report (a 44% improvement).
• Playbooks Needed:  Even amongst those with a formal security response plan, only one third (representing 17% of total respondents) had also developed specific playbooks for common attack types — and plans for emerging attack methods like ransomware lagged even further behind.
• Complexity Hinders Response:  The amount of security tools that an organization was using had a negative impact across multiple categories of the threat lifecycle amongst those surveyed. Organizations using 50+ security tools ranked themselves 8% lower in their ability to detect, and 7% lower in their ability to respond to an attack, than those respondents with less tools.
• Better Planning, Less Disruption: Companies with formal security response plans applied across the business were less likely to experience significant disruption as the result of a cyberattack. Over the past two years, only 39% of these companies experienced a disruptive security incident, compared to 62% of those with less formal or consistent plans.

"While more organizations are taking incident response planning seriously, preparing for cyberattacks isn't a one and done activity," said Wendi Whitmore, Vice President of IBM X-Force Threat Intelligence. "Organizations must also focus on testing, practicing and reassessing their response plans regularly. Leveraging interoperable technologies and automation can also help overcome complexity challenges and speed the time it takes to contain an incident."

Updating Playbooks for Emerging Threats The survey found that even amongst organizations with a formal cybersecurity incident response plan (CSIRP), only 33% had playbooks in place for specific types of attacks. Since different breeds of attack require unique response techniques, having pre-defined playbooks provides organizations with consistent and repeatable action plans for the most common attacks they are likely to face.   

Amongst the minority of responding organizations who do have attack-specific playbooks, the most common playbooks are for DDoS attacks (64%) and malware (57%). While these methods have historically been top issues for the enterprise, additional attack methods such as ransomware are on the rise. While ransomware attacks have spiked nearly 70% in recent years, 2 only 45% of those in the survey using playbooks had designated plans for ransomware attacks.

Additionally, more than half (52%) of those with security response plans said they have never reviewed or have no set time period for reviewing or testing those plans. With business operations changing rapidly due to an increasingly remote workforce, and new attack techniques constantly being introduced, this data suggests that surveyed businesses may be relying on outdated response plans which don't reflect the current threat and business landscape.

More Tools Led to Worse Response Capabilities The report also found that complexity is negatively impacting incident response capabilities. Those surveyed estimated their organization was using more than 45 different security tools on average, and that each incident they responded to required coordination across around 19 tools on average. However, the study also found that an over-abundance of tools may actually hinder organizations ability to handle attacks. In the survey, those using more than 50 tools ranked themselves 8% lower in their ability to detect an attack (5.83/10 vs. 6.66/10), and around 7% lower when it comes to responding to an attack (5.95/10 vs. 6.72/10).

These findings suggest that adopting more tools didn't necessarily improve security response efforts — in fact, it may have done the opposite. The use of open, interoperable platforms as well as automation technologies can help reduce the complexity of responding across disconnected tools. Amongst high-performing organizations in the report, 63% said the use of interoperable tools helped them improve their response to cyberattacks.

Better Planning Pays Off This year's report suggests that surveyed organizations who invested in formal planning were more successful in responding to incidents. Amongst respondents with a CSIRP applied consistently across the business, only 39% experienced an incident that resulted in a significant disruption to the organization within the past two years  compared to 62% of those who didn't have a formal plan in place.

Looking at specific reasons that these organizations cited for their ability to respond to attacks, security workforce skills were found to be a top factor. 61% of those surveyed attributed hiring skilled employees as a top reason for becoming more resilient; amongst those who said their resiliency did not improve, 41% cited the lack of skilled employees as the top reason.

Technology was another differentiator that helped organizations in the report become more cyber resilient, especially when it comes to tools that helped them resolve complexity. Looking at organizations with higher levels of cyber resilience, the top two factors cited for improving their level of cyber resilience were visibility into applications and data (57% selecting) and automation tools (55% selecting). Overall, the data suggests that surveyed organizations that were more mature in their response preparedness relied more heavily on technology innovations to become more resilient.

About the Study Conducted by the Ponemon Institute and sponsored by IBM Security, the 2020 Cyber Resilient Organization Report is the fifth installment covering organizations' ability to properly prepare for and handle cyberattacks. The survey features insight from more than 3,400 security and IT professionals from around the world, including the United States , India , Germany , United Kingdom , Brazil , Japan , Australia , France , Canada , ASEAN, and the Middle East .

Review the full report here: https://www.ibm.com/account/reg/us-en/signup?formid=urx-45839

Sign up for our correlating webinar taking place July 23 at 11:00 AM ET here: https://event.on24.com/wcc/r/2448121/9297B87DE7A378D816846835989BD762

About IBM Security IBM Security offers one of the most advanced and integrated portfolios of enterprise security products and services. The portfolio, supported by world-renowned IBM X-Force® research, enables organizations to effectively manage risk and defend against emerging threats. IBM operates one of the world's broadest security research, development and delivery organizations, monitors 70 billion security events per day in more than 130 countries, and has been granted more than 10,000 security patents worldwide. For more information, please check  www.ibm.com/security , follow @ IBMSecurity  on Twitter or visit the  IBM Security Intelligence blog . 

Media Contact: Kim Samra IBM Security [email protected]     510-468-6406

1 IBM Security and Ponemon Institute: 2019 Cost of a Data Breach Report

2  IBM Security, 2020 X-Force Threat Intelligence Index , (2020), p. 15

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