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 diversity in clinical trials because once the drug is out in the market, it will be an intersection of potentially all of those identities and many things going on in their life that might affect how they respond. So, when we're thinking about race as a diversity point, we might be using it as a proxy for a specific type of individual, a specific patient journey that we want to make sure to include. It's not necessarily that race is the end-all, be-all measure of diversity; it's that we want to capture the true patient experience for that disease.

Dr. Ana Maria Lopez: What I think is also really interesting is how we collect the data. And some of what the last couple of years have taught us is that folks may not trust our healthcare systems, and so folks may not be willing to say, ‘I am X, Y, or Z,’ which certainly puts us a little bit in the void. So how important it is for us as clinicians, as researchers, to be part of creating an environment where patients can feel that ‘Yes, I can trust and I can share, and I can say, this is who I am,’ because that could impact clinical care.

Dr. Carol Brown: So, acknowledging that race is a social construct and that it really is used as a surrogate for other social determinants of health and other factors that affect health, and again, really acknowledging what you said, Dr. Lopez, that even asking people to identify their race is extremely problematic. But given what we do know and what our experience has been in the clinical trial world, first, Mr. Bebi, could you comment about what has been your experience and your research with the current state of participation by diverse racial and ethnic groups in clinical trials in the United States? What have you found in your research? 

Ted Bebi: Recently, at Metidata, we published a paper where we looked at the state of black participation in clinical trials. We found the level at which you look at the data really matters. For example, when we looked at racial diversity across all US trials, black representation actually matched the proportion of black people represented in the 2020 US National Census, which is about 14%. But looking deeper, there were actually huge differences by therapeutic and disease area. And specifically, we saw that in oncology, black participation was only at around 8.5%, so far below the representation of black people in the United States.  

Another interesting story is that when we were looking at the central nervous system therapeutic area, overall, we saw a pretty high rate of black participation at around 20%. But when we looked at one of the largest central nervous system indications, Alzheimer's, we saw only 5% black participation, so much, much lower. What we discovered is that within this therapeutic area, there were actually a lot of psychiatric trials that were driving the rate up. So, the main takeaway from this research is that you cannot take a general level of diversity as adequate for all diseases. You really have to zoom in on the specific indication to understand what constitutes good diversity or representative diversity for that disease.

 Dr. Carol Brown: I'd like to ask both of you what do you think about that - what the bar should be. Because Mr. Bebi, you mentioned using the census distribution of races in the population, but I think a lot of us in the cancer field feel like that maybe isn't the right bar. Maybe the bar should really be what is the cancer burden distributed according to self-identified race, ethnicity, or other categories. And when you look at that, I think you find some different statistics. So, Dr. Lopez, could you comment about what your work has shown you about the current state of representation of diverse people affected by cancer in cancer clinical trials, and maybe get a little bit more into what you were saying earlier about the definition of race and the challenge of determining race, etc.

Dr. Ana Maria Lopez: We really need to look closely at the data, and that looking at therapeutic trials and at specific populations can be really important. Now, we're a big country, so there can be - what is the catchment area that you serve? And in that catchment area, what are the cancers you're treating, and in which populations are at greatest risk? But right, sometimes it may not be - let's say the population is 10%x, but if that population is at higher risk for a certain disease, to really get granular about the understanding, I need to recruit more people that are from that greater-risk population. So that's where I think it's so important to know the population, to have connections with the community. And actually, the community can say, “Hey, this is what you may want to be studying because this is what impacts us.”

Ted Bebi: If I can speak on the research side as well, the best way to ensure representative diversity is to have a very solid understanding of the natural prevalence of a disease. We need to be able to understand what the risk populations are and, even further, what does the mortality look like? Are there differences in how different patients are experiencing the disease further on, not just how they're getting the disease and how often they're getting the disease? So it needs to look different for every single indication. And even with the oncology, for example, the two largest indications in clinical trials for oncology, lung cancer and breast cancer, they also look slightly different. With lung cancer, and our research showing at 8% black participation and breast cancer being a little bit higher at around 11%. So, we always need to take into consideration that incidents include prevalence, include mortality. And yes, the golden standard should be can we build a clinical trial that reflects the actual representative diversity of the disease in the real world? That is what we're striving for.

Dr. Carol Brown: I would agree with that. I would also add, though, that there may be some specific cancers for which you want to have an even greater representation of a particular group because it might be directly related to the question you're trying to answer. So, for example, you mentioned breast cancer, so I think most of the audience is probably aware that young women who self-identify as black tend to have a higher mortality from breast cancer. And this is believed to be because they are more likely to get triple-negative breast cancer. And so one of the strategies we've looked at at our cancer center is for trials specifically for triple-negative breast cancer, trying to overrepresent women who self-identify as black or have African ancestry in those trials because we're specifically trying to make sure that we do something to narrow that gap in survival from breast cancer that they experience. So, I think that, as you all mentioned, I think what we can take from this is it's really important to look closely that there are different layers and subtleties that we have to take into account. 

So, I think we've clearly established that there is underrepresentation of diverse groups. But let's talk about why. So why do we think that different self-identified races and ethnicities or age groups or socioeconomic status background people are underrepresented in clinical trials? What are some of the reasons in your experience for this, Dr. Lopez? Is it funding outreach? What are the main barriers that you've experienced in terms of getting diverse populations to participate in clinical trials?

Dr. Ana Maria Lopez: Maybe all of the above. But one of the things, and one of the things that we're working on, is when a person comes in and you have the trauma of the diagnosis. And they're offered a study, and there may be suspicion of the health care system, that may not be the best time to really talk and educate around a clinical trial. So, if people receive the education, learn about clinical trials before that acute event, then they can come in more prepared. So, one is just the concepts of randomization, double blind in the setting where there may be distrust of the healthcare system may be difficult. Also, some of the clinical trials, and I'm sure everyone has studies where the person needs to be at the clinic for about 12 hours getting blood draws. And people have other responsibilities, and they may not have the support mechanisms for transportation, for childcare, for elder care. And if you're taking two to three buses and, you know, here I am in Center City, Philadelphia, and you need to take two to three buses to get home at 07:00, that could be a deterrent to getting on a clinical trial.  

So, there are lots of clinical factors, social factors, experience with the studies, and also how we design the studies. Can we design studies so that we are more inclusive in the criteria? So, I think lots of questions, and then certainly there are clinician factors. There could be bias that we all have that maybe we don't offer studies to certain people, so something for us to be very introspective about as well.

Dr. Carol Brown: So, Mr. Bebi, could you comment specifically on, with the research that you've done, are there some barriers on the side of the sponsors of the trials or in terms of industry that you found and that you found in your work at Medidata, maybe really affecting the ability of diverse people to participate in clinical trials?

Ted Bebi: Dr. Lopez did a really good job at presenting what we consider patient-level barriers, such as mistrust in the healthcare system. Logistical issues such as taking time off from work, transportation, or feeling that the investigators running the trials don’t fully represent the patient. But the industry-level barriers are just as important. A lot of companies are making decisions on what good diversity should look like and where they can find more diverse patients based on incomplete data sources such as disconnected external data, or they might be limited to data from the companies. 

Dr. Carol Brown: Great. So, Dr. Lopez, what do you think individual physicians can do, or individual investigators can do to improve the diversity of representation in cancer clinical trials?

Dr. Ana Maria Lopez: Certainly, being circumspect, being aware of our own biases, our own approaches. But as a health system, I think we need to think about: How can we make it easy to enroll people into trials? So are there ways, if this is, for example, a study for people at this stage of cancer, that all of those patients could be screened in the electronic record? Let's have our electronic tools work for us so that we identify patients that are meeting the study criteria and then connecting the patients, the study, and the investigators together. So, this way, by having our systems identify potential participants, there's a less chance of there being that personal bias. The research team can come to the doctor, to the oncologist, let's say, and say these are folks that are eligible. What do you think? So, in a way, setting up systems to help with the recruitment would be very helpful.

Dr. Carol Brown: Mr. Bebi, can you comment from the standpoint of specifically– because you focus on this– the importance of data, the data, how to capture the data about race or ethnicity or whatever the demographic diversity variable is, what can individual investigators do to really address the challenges around collecting this data and sharing it?

Ted Bebi: Often, race and ethnicity data is not even captured at all. So, if we want to understand this issue better and improve upon it, we need better data inputs in order to produce this large-scale research that will help us ultimately advance the issue and not just rely on anecdotal information.

Dr. Carol Brown: Are there any technologies or things that you came across in your specific work that can help with this ability to capture this type of data and to share it?

Ted Bebi: I think it has more to do with the awareness and the clinician relationship with the patient. And I also think it has to do with sponsors and the way that they design the trial, to begin with, whether or not the race and ethnicity entry is something that they're asking in their electronic health forms. Because if that is not included in the clinical trial, to begin with, then there won't be any incentive to capture that information.

Dr. Carol Brown: Dr. Lopez, do you have any specific tips that you would recommend to clinicians who want to improve recruitment of underrepresented groups in their clinical trials?

Dr. Ana Maria Lopez: I think one thing that's really important is to be able to have the time. Now, that may not mean that it's all the clinicians' time. It may mean that you have a research coordinator. It may mean that you have a research nurse. It may mean that you give the patient a video that explains the study that they can take home. There can be different ways. Something that I often ask a patient is, “How do you make decisions?” People tell me, “You know, I always go over this with my wife,” let's say, or, “I always discuss this in our family, and then we come to a conclusion.” Because that really helps me to think about how should I best deliver the information so that the patient can really feel I made a good decision and I made a value-congruent decision. So, I think time is critical and to set up our patient experience to really facilitate that type of experience for the patient. 

Also, as a reference, I would urge people to take a look at the recent recommendations put out by ASCO and ACCC that talk specifically about increasing racial and ethnic diversity in cancer clinical trials. So, there are lots more strategies, a lot more ideas, and ways to really support clinicians and researchers.

Dr. Carol Brown: Mr. Bebi, do you have any specific tips, particularly for trial sponsors, about how they can improve diversity in their clinical trials?

Ted Bebi: In terms of companies and sponsors, what they can do if they want to improve diversity in their trials is they need to find and include the right sites that serve the populations that they are looking for. We published research that shows that there is high variability of diverse recruitment based on which sites you are looking at, with some sites providing the highest concentration of diverse patients. So, if diversity is not woven into trial design off the bat and you're not selecting the right sites, you run the risk of not reaching these populations.

Companies also need to be willing to put in work to educate and develop sites into clinical trial sites. A clinical trial site is about building trust and relationships and knowing how to be culturally adept at talking to diverse communities.  

Dr. Carol Brown: Great. Thank you so much. Well, I want to thank both of you, Dr. Lopez and Mr. Bebi, for a lively discussion on this ASCO Education podcast about diversity in clinical trials.  

The ASCO Podcast is where we explore topics ranging from implementing new cancer treatments and improving patient care to oncologist well-being and professional development. If you have an idea for a topic or a guest you'd like to see on the ASCO Education Podcast, please email us at [email protected]. To stay up to date with the latest episodes and explore other educational content, please visit education.asco.org. 

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

The purpose of this Podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  

Guests on this Podcast express their own opinions, experience, and conclusions. Guest statements on the Podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.