Cancer Topics - Racial Disparities in Clinical Trial Participation

Clinical trials are essential to progress in medicine, but racial and ethnic minorities are frequently underrepresented in such studies. In this ASCO Education podcast episode, we will examine this issue with Dr. Carol Brown, gynecologic cancer surgeon and Chief Health Equity Officer at Memorial Sloan Kettering Cancer Center, Dr. Ana Maria Lopez, Professor and Vice Chair of Medical Oncology at Sidney Kimmel Medical College and former Chair of ASCO's Health Equity Committee and Mr. Ted Bebi, Innovation Manager at Medidata Solutions. They discuss how diversification of clinical trials contributes to health equity (4:03), barriers to participating in clinical trials (14:37), and what clinicians and trial sponsors can do to improve participant diversity in clinical trials (20:25).
Speaker Disclosures Dr. Carol Brown – None Ted Bebi: Employment – Medidata (a Dassault Systèmes company); Stock and Other Ownership Interest – Pfizer, Eli Lily, Abbvie, Merck, BMY Dr. Ana Lopez - None
Resources
• ASCO-ACCC Initiative to Increase Racial & Ethnic Diversity in Clinical Trials
• Journal Article: Increasing racial and ethnic diversity in cancer clinical trials
• Journal Article: Representation of minorities and women in oncology clinical trials
• Podcast: Impact of Implicit Racial Bias on Oncology Patient Care and Outcomes
• ASCO-ACCC JustASK Training Program
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TRANSCRIPT
Dr. Carol Brown: Welcome to the ASCO Education podcast. I'm Dr. Carol Brown, a gynecologic cancer surgeon and the Chief Health Equity Officer at Memorial Sloan Kettering Cancer Center. Our guests and I will be exploring the problems and solutions with regards to racial disparities in clinical trials.
A necessary element for conducting clinical trials is, obviously, the enrollees or participants. Racial and ethnic diverse groups are frequently underrepresented in clinical trials, despite having a disproportionate burden for certain cancers. In addition, there is increasing evidence that a person's individual genetic makeup may determine the level of toxicity or efficacy of a new cancer drug specifically. Therefore, when we don't have enough diversity in our cancer clinical trials, it can really undermine the generalizability of our results. And so, to address this gap, in its recent updated guidance to industry, the US Food and Drug Administration stated that enrollment in clinical trials should reflect the diversity of the population who ultimately use a treatment.
In 2022, ASCO and the Association of Community Cancer Centers issued a joint statement recommending that anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving equity, diversity, and inclusion.
Joining me to discuss this important topic today is Dr. Ana Maria Lopez, who's the Professor and Vice Chair of Medical Oncology at the Sidney Kimmel Medical College. And she's the former Chair of ASCO's Health Equity Committee. Our second guest is Mr. Ted Bebi, Innovation Manager at Medidata Solutions. His research explores underrepresentation of black patients at clinical trials and how diversity impacts clinical trials.
Participant disclosures for this episode are listed on the podcast page.
So why should we care about improving diversity in clinical trials? Dr. Lopez?
Dr. Ana Maria Lopez: We are clinicians. We are wanting to take care of our patients as best as possible, and we can only do that if our studies include everyone. An example that I often think about is the concept of airbags began in 1953, and in 2008, the National Highway Traffic Safety Administration came out and said, "You know what? We should be testing airbags on small female crash test dummies because otherwise, we don't know that these airbags will be safe." And in fact, there were data that the airbags that existed put women and children at a much higher risk for injury or death. So, we want to be ahead of that curve, and we want to allow the best possible treatment.
Dr. Carol Brown: So, Mr. Bebi, what would you say about how we could improve diversity in clinical trials?
Ted Bebi: So I really like the example of the airbags that Dr. Lopez brought up because it makes it clear when building a product it's important to test the product in a representative sample of the population that will ultimately end up using it. It's the same with products like medications. If you want an efficacious drug, you should test it in the appropriate population. It's what constitutes good science. Additionally, adequate diversity in clinical trials is also important because it's ultimately an issue of health equity and providing fair access.
Dr. Carol Brown: Could you kind of go on from there and talk about, specifically, how does diversifying the group of people that participate in clinical trials actually translate into increasing health equity?
Ted Bebi: Well, participating in a clinical trial is a form of receiving health care. Often, we are talking about patients for which a clinical trial might be their last resort. And even if not, participating in a clinical trial means gaining early access to potentially life-changing drugs that could become the new industry standard and doing so at no cost. So, you're receiving care and follow-up from some of the best specialists in the field. So having fair access to this opportunity for all patients is definitely a health equity issue.
Dr. Carol Brown: Great. Dr. Lopez, how would you answer that question about how does diversifying clinical trials contribute to health equity?
Dr. Ana Maria Lopez: Yeah, no, I think I agree with everything that Mr. Bebi said. In addition, I think we have to remember that diversity is more than race. Race is truly a social construct. We need to think about gender. We need to think about age, the whole lifespan, and people are living longer. How we metabolize medications at different time points in our life may vary. So, lots of different factors that we can consider when we think of diversity. But the gold standard is really: Are folks getting the best outcome possible? And as long as that metric is not being reached, we need to be thinking of how can we facilitate that.
Dr. Carol Brown: So, Dr. Lopez, you brought up this concept that health equity is really the best outcome possible. Could you comment a little bit about how do we know, particularly in cancer, what is the best outcome possible? So how do we determine what the reference is for that, so we can figure out whether our patients are actually getting health equity?
Dr. Ana Maria Lopez: Sure. So, we use different time points. We can look at relapse rates, survival rates, and of course, part of that may be comorbidities. Certain comorbidities that people have may impact their cancer treatment outcomes. So, it is complex, but it is important for us to take a look contextually at what the patient's risk is and what the patient's outcome would be.
Dr. Carol Brown: We can kind of all agree that when we're talking about equity, it's getting the best outcome for everybody, no matter what they're bringing to it. And I really like your comment, Dr. Lopez, about race being not only the only factor but remembering that it is a social construct. If you could add to that, Mr. Bebi.
Ted Bebi: We're talking a lot about diversity in clinical trials in terms of race and ethnicity, and that is something that is ultimately very important. But we're talking about diversity in all sorts of aspects. We're talking about diversity with age. We're talking about diversity with sex, with socioeconomic aspects because we often use race as a proxy for other things that might be going on in patients' lives. And we need to consider all of this part of …