Ulcerative Colitis Resource Center

Ulcerative Colitis Resource Center

Disclosures: Rubin reports receiving grants from Takeda and consulting for AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, Genentech/Roche, InDex Pharmaceuticals, Iterative Scopes, Janssen Pharmaceuticals, Lilly, Pfizer, Takeda and Techlab Inc. The other authors report no relevant financial disclosures.
November 19, 2021
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Q&A: Diversify IBD trials to better understand disease in different populations

Disclosures: Rubin reports receiving grants from Takeda and consulting for AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, Genentech/Roche, InDex Pharmaceuticals, Iterative Scopes, Janssen Pharmaceuticals, Lilly, Pfizer, Takeda and Techlab Inc. The other authors report no relevant financial disclosures.
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In a commentary published in Gastroenterology, experts propose initiatives that aim to increase diversity in inflammatory bowel disease clinical trials.

Nathaniel A. Cohen, MD, advanced IBD fellow at the University of Chicago Medicine Inflammatory Bowel Disease Center, and colleagues identified 641 publications that included 24,315 patients in pivotal IBD trials. There were 32 trials that included race demographics and 10 that included ethnicity demographics. Of these trials, only 12 mentioned the percentage of white participants and 20 reported increased breakdown of race demographics, including a combination of white, Black, Asian, Native Hawaiian or Pacific Islander, Native American, Hispanic and other.

Healio Gastroenterology spoke with Cohen and David T. Rubin, MD, Chief of Gastroenterology, Hepatology and Nutrition at University of Chicago Medicine and Chair of the National Scientific Advisory Committee of the Crohn’s & Colitis Foundation, on factors leading to underrepresentation of minorities in IBD trials and ways to increase diversity in the trials.

David T. Rubin, MD
David T. Rubin

Healio: Can you describe the review you performed?

Cohen: It's been felt and obviously observed that there is a significant underrepresentation of racial minorities and ethnic groups in clinical trials. It's something that although discussed it has never actually formally been shown. So we decided to take a look at all of the past randomized clinical trials of treatments for IBD — which actually go all the way back to the end of the 1960s — through to the latest studies from the last decade and the last few years. We looked at the total number of participants and obviously the percentages of the different racial and ethnic minorities. We reported this, and then we looked specifically at how this changed over the course of decades and at the way the clinical trials were structured and progressed. Initially clinical trials were performed in a single country. Then the trials became multi-center and international. Now they include 20 to 30 countries with hundreds of sites, and we looked at how that change affected the representation of minorities.

Rubin: The reason we did a time trend analysis was also due to recognizing that the diversity of people affected by IBD has shifted over the years. IBD was described in the earlier part of last century as being a disease largely of white people. Over the decades, it has become obvious that this is a condition that affects all races and ethnicities equally. With that recognition, we wanted to see if the clinical trial participation became more obviously diverse, and it did not. One change was there was a movement of clinical trial recruitment from Western Europe and the United States to Eastern Europe and Asia. The reason for that is because of emerging IBD in those regions, sizes of populations and relative scarcity of otherwise available therapies. In other words, people get into clinical trials because they didn’t have other options available to them, which is ethically questionable. But that is the reality of global medicine.

Healio: Why do you think minority groups do not want to participate in clinical trials?

Cohen: We've discussed multiple reasons. It comes from the multiple layers in medicine including patient factors, physician factors, health system administration factors and global factors.

A lot of underrepresented minorities had some distress in big centers. Throughout history, there have been instances where there have been experiments conducted on certain racial minorities. There are incidences where the medical fraternity is not what we'd expect it to be. This has caused a lot of distress in certain populations and makes them a little bit less likely to want to be involved in what they see as experimental clinical trials. Factors may be related to the way we educate patients.

That brings us to the physician side. We may not be good at communicating certain elements. There may also be a physician bias — we feel certain patients with certain backgrounds may not be able to complete clinical trials.

There are structural problems where there's inadequate access to health care in certain underrepresented minorities, where they don't have access to top quality centers where these clinical trials may be running; there may be financial issues where they don't have ways of getting to the centers.

It's very layered. And therefore there are multiple factors which need to be addressed. We looked at all those factors and proposed changes for them.

Rubin: When there's discordance between the investigator and their racial/ethnic background and that of the patient, there can be a disconnect there, and that leads to either a simple misunderstanding, cultural incompetence, or mistrust.

Healio: How are these findings compared with those from other randomized control trials on other conditions?

Rubin: We have been seeing more studies popping up with the same methodology and review across other disease states. I suspect that this is widespread and a big problem in many areas. If you have diseases that are confined to specific subgroups and you can't study them otherwise, then I suspect that might be different. They may have a whole different amount of investment into their disease states.

Cohen: What we describe in IBD trials hasn’t been well described in cancer trials and diabetes trials where there isn’t a big discrepancy or there may be more incidences of disease in underrepresented minorities. But they are truly underrepresented in clinical trials. It has been described and it is being looked at in other fields as well.

Healio: What changes need to be made with IBD clinical trials to increase representation of minorities?

Rubin: We thought it was important in this paper to have a call to action. We wanted to provide a roadmap for what we believe are the necessary steps to improve the status quo. We broke it into the different phases of study: design, recruitment, reporting, analysis, regulatory approval, and post marketing. In each of these areas we emphasized an appropriate intervention that we believe would improve the participation in trials with a diverse population, but it’s going to take a lot of work.

 

It’s not just about having diversity represented, but also about physicians doing appropriate substudies to recognize if the therapies work differently in different populations and to understand why. There are important reasons this should be built into clinical trials going forward. We are hopeful that the industry, the NIH and the Crohn’s & Colitis Foundation will pay attention to these important suggestions and adopt them.

This is something that is long overdue.

Rubin reports receiving grants from Takeda and consulting for AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, Genentech/Roche, InDex Pharmaceuticals, Iterative Scopes, Janssen Pharmaceuticals, Lilly, Pfizer, Takeda and Techlab Inc. The other authors report no relevant financial disclosures.