Cheryl Byers and Dr. John H. Stewart Discuss Diversity, Equity and Inclusion in Cancer Research
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About this Episode:
Diversity, equity, and inclusion (DEI) in cancer research are critical to clinical research. In this episode, Advarra’s Cheryl Byers and Dr. John H. Stewart have a discussion on what is DEI, the current climate of DEI in cancer research, and considerations to improve DEI in clinical trial enrollment and retention.
Cheryl Byers (00:04): Hello, my name is Cheryl Byers and I’m the Vice President for Institutional Partnerships here at Advarra. And today I’m joined by Dr. John Stewart.
John Stewart (00:14): Hello as well, my name is Dr. John Stewart, I’m the Deputy Director of the University of Illinois Cancer Center.
Cheryl Byers (00:20): I’m really excited to be joined by Dr. Stewart for the second episode of Advarra in Conversations With…
It’s really a pleasure to team up with a former colleague and a friend to hold an important discussion about diversity, equity, and inclusion in cancer research, as well as within the clinical research ecosystem as a whole.
John Stewart (00:39): Let’s go! I am equally excited to be joining for this discussion.
Cheryl Byers (00:42): So, Dr. Stewart, what does it mean when we say we’re talking about diversity in cancer research?
John Stewart (00:49): So, limited diversity in cancer research reduces output and yields applications that do not speak to the complexity of cancer and its impact on minority populations.
I would think that the diversity of participation and underserved populations in clinical trials is a critical link between scientific innovation and improvements in healthcare delivery and health outcomes. Unfortunately, these populations often do not participate in clinical trials due to a number of factors, and this decreases the diversity and applicability of the findings for clinical trials. And so, some of the primary factors are: Distrust of the medical system, lack of awareness of clinical trials among patients and physicians, limited opportunities to participate inadequate health insurance (which we will delve into a little later during our discussion), and the logistical burdens of trial participation; and these burdens include cost, transportation, and study duration.
Cheryl Byers (01:45): And, could you briefly touch on the differences between diversity, equity, and inclusion, which by the way, I may shorten at times to DEI just for brevity.
But if you could briefly touch on the differences between diversity, equity ,and inclusion and why these nuances are important to efforts to improve DEI in cancer research.
John Stewart (02:05): Sure, so I think now’s a great time for us to really dig deeply and establish shared understandings of what these terms mean, so that we’re able to hold these terms as separate concepts and understand how they interact, and subsequently be able to have clear goals and strategies around them.
Diversity is actually the presence of differences within a given setting, including diversity of identities, like race and gender and, in some cases, ethnicity, religion, nationality, or sexual orientation. In fact, these identities have received systematic discriminatory treatment and created advantages/disadvantages in barriers to opportunity and resources.
So, when we think about the term inclusion, it is about people with different identities feeling valued, leveraged, and welcomed within a given setting. With this in mind, diversity does not necessarily equal inclusion, and to quote Verna Myers, a leader in diversity: “Diversity is being asked to the party. Inclusion is being asked to dance.” So, for example, you can have a diverse study team that does not mean that every participant feels welcomed or is valued as giving opportunities for advancement or gets clear mentorship and sponsorship.
By the same token, you can have a diverse patient population, but not every study participant feels respected or included in projects that advance science.
Equity, on the other hand, is an approach that ensures everyone has access to the same opportunities, to be in clinical trials or for members of the research team. So, equity recognizes that advantages and barriers exist and that as a result, we all don’t start from the same place. Equity is a process that begins by acknowledging that we are at an unequal starting place, and equity makes a commitment to correct and address this imbalance and I believe that conversation, such as the ones that we will be having today or important starting steps that the real work begins with actions targeting the root causes of inequities.
Cheryl Byers (04:04): Great, and something you and I have spoken about previously is mistrust of individuals, specifically minority populations in the medical system, and you mentioned it, sort of, in your in your intro few minutes ago. But why is mistrust in the medical system, something we have to address as part of the discussion?
John Stewart (4:23) Right, so the medical establishment has a long history of mistreating Black Americans from experiments on enslaved people, to forced sterilizations of black women, and the infamous Tuskegee Syphilis Study, that withheld treatment from hundreds of Black men for decades to let doctors track the course of disease. And I think that it is these experiences that actually lay the foundation for the findings from an October 2020 poll that was produced by the COW’s of Kaiser Family Foundation and the Undefeated that found that 7 of 10 Black Americans say that they are treated unfairly by the health system and 55% say that they distrust it. And so, people who distrust the medical establishment are less likely to follow medical advice or even seek medical treatment, they’re less likely to participating complex treatment trials or participate in clinical trials.
Cheryl Byers (05:14): So, what can we do to rebuild the trust in the medical system?
John Stewart (05:18): I think that rebuilding trust actually requires a presence and an involvement in the community, I like to call this Community Sweat Equity, right? It takes a lot of time, it takes honest engagement, and it takes honest follow through in order to rebuild the trust, so that people see that you are genuinely concerned about health issues that occur in the communities. Now the other part of it, too, is that it is really hard to distrust study teams that look like the community. So that speaks to the need of having a diverse study pipeline or clinical research pipeline that reflects the community.
Cheryl Byers (6:02): Can you talk a little about the kinds of actions or trends that we need to evaluate to really address diversity, equity, and inclusion in clinical research; specifically cancer research.
John Stewart (06:12): Sure, so I think that there are three trends that we really need to track moving forward.
We need to delve into mistrust of the medical system that we talked about before, we need to think about participatory patterns in clinical trials, and then we need to think about the pipeline. So, let’s further our conversation around the mistrust of the medical system in certain communities. So, just out of the gate, healthcare systems need to provide excellent care with outstanding patient experience every time. Just being good enough, is not good enough; we need to hold ourselves to very high standards so that patients feel valued when they engage in the health system.
Secondly, as I mentioned before, health systems need to have a presence in the community. I think back to my example of when I was a medical student and the year must have been 1993 or 1994 when we were doing a health fair and one of the members of the community said, “You know this is great, but why don’t you come see us when you need something.” And so, as I thought about that, that really helped mold my thinking and my activities around having a community presence, so that we can address issues that although initially look like they reside outside of cancer, they actually impact the community in terms of ultimately coming to the health system and at sometimes you might even need involvement with the care network.
And then thirdly, we have to partner with the community to build relationships that facilitate trust in the organization. So I think back on a group that I’m actually one of the one of the Principal Investigators on, that’s called ChicagoCHEC, which is Chicago Cancer Health Equity Consortium, which is a partnership between the University of Illinois Chicago, Northwestern University, and Northeast Illinois University. And which we actually have a community advisory board that has input not only into the research that we do, but also into some of the care practices or practices that we have and interactions with the community. We’ve actually had some extraordinarily positive movement in the healthcare systems based upon interactions that we’ve had with our community advisory board.
Now, the second thing that we really need to think about as we track DEI in cancer research is understanding participatory patterns. But I would like to draw the audience’s attention to some work that I did with Dr. Lola Fayanju, who is currently at Duke, on participatory patterns in surgical oncology trials. And so, just by way of background, you know Fisher and their team demonstrated that we have an equity problem in clinical trial participation; in that African American and Latinx patients are actually overrepresented in Phase I clinical trials, while they’re underrepresented in Phase II trials.
So, if you think about that, you know Phase I trials are safety trial, safety and dosing trials, and there is no primary endpoint around treatment.
Phase III trials have primary endpoints around efficacy of treatment. And so, the differences in participation actually speak to an inequity in patients who do actually go on to clinical trials, and I think that’s a big problem. But if we think about the work that Dr. Fayanju published in December of 2019, around surgical participation in surgical oncology trials for breast cancer, we found that Black and Hispanic patients were 15-20% less likely to be involved in trials than white patients. And, if you think about the larger cooperative group trials around breast that had more than 1000 slots per year, high income Latinx and Black patients were about 45 and 35% less likely to participate in those trials than high income whites. So, if you take these data together, it demonstrates that it’s not necessarily about income equaling high access to trials equaling high participation, but it’s a little bit more complex than that.
And so, as we move forward, we have to prospectively evaluate participatory patterns that speak to health literacy, that speak to interaction with the healthcare community, but also speak to the patient experience and prepping patients and putting support services around set patients to participate in trials. And then, we also need to really understand what the perception is of these high income, underrepresented minority patients are that lead to the decision to participate or not participate in these trials.
Cheryl Byers (11:08): That’s really interesting, I like that you guys took a deeper dive into, you know, specifically breast cancer patients and the racial disparities there so that’s really interesting.
So recently, the Food and Drug Administration released some guidance on enhancing diversity and clinical trials and recommended that sponsors take steps to reduce participant burden, such as increasing visit windows and reducing the frequency of visits to specific sites.
The FDA also mentioned, greater use of electronic communications, such as emails or phone calls for visits. What other types of interventions are important to improving clinical trial enrollment and retention?
John Stewart (11:50): Sure, so I would say that, let’s think about the way that clinical trials are actually created. Typically, these clinical trials are created by groups that do not include community participants. It is awfully important for us to have the patient voice and the community voice in the design of these trials.
The other thing that I think needs to be addressed with respect to the design of the trials is to re-evaluate exclusion and inclusion criteria. So, there have been a plethora of data, and you know these data were first reported by Dr. Lucile Adams-Campbell from the Georgetown University Lombardi Cancer Center, that suggested that many times, African American patients are excluded from clinical trial participation due to comorbid conditions. To be honest, the vast majority of patients in society have comorbid conditions, and so we need to reevaluate the exclusion of these patients from clinical trials. I think that understanding that the population of the United States is changing is an important concept that we need to embrace as we consider diversity, equity, and inclusion in clinical trials. And having said that, is that we’re having increased numbers of patients being either bilingual or multilingual and having patient navigators with those skills is an important approach to increasing participation in clinical trials. We do know that clinical trials, the clinical trial consent process needs to be culturally sensitive and linguistically appropriate. And so, having patient navigators that bridge that language difference is important.
Cheryl Byers (13:37): Great, thank you. So now, I want to get into one of my favorite topics, which is policy change. Why is policy change essential to creating actionable change as it relates to diversity, equity, and inclusion and clinical trials?
John Stewart (13:51): So, if we think about disparities in the social ecologic framework, the top of that framework is that of policy. Because changing policy is really our chance to change the activities of multiple stakeholders at one time, and you know, there are two important policy changes that have occurred within the past year around clinical trial participation.
The first one was the Clinical Treatment Act of 2020, that was introduced by Senator Richard Burr – from my home state of North Carolina – and Ben Cardin. And so, prior to this legislation, Medicaid was the only major insurance provider that did not cover routine costs associated with participation in clinical trials. And actually, coverage for clinical trials was already assured for Medicare beneficiaries and for patients with private health insurance.
At the time, 15 states and Washington, D.C. actually required Medicaid programs to cover costs that were associated with participation in clinical trials, yet there was still as many as about 41 million Americans who were insured through Medicaid, who did not have this crucial coverage that they needed. This legislation actually require that all state Medicaid programs cover routine care costs for individuals participating clinical trials for serious or life threatening conditions, including cancer.
The second significant piece of legislation was actually the Henrietta Lacks Enhancing Cancer Research Act of 2020. This legislation ensures that all patients, especially those from communities of color, are fairly represented in clinical trials and ultimately receive the treatments that they deserve.
Page BreakSo, this act actually requires that the Government Accountability Office, or the GAO, to complete a study that reviews how Federal Agencies address barriers to participating in federally-funded cancer trials by individuals from underrepresented populations. I think that this review will open up opportunities for us to have further funded considerations around these important issues.
Cheryl Byers (16:03): That’s terrific, and I completely agree with you. I’m very excited about these two policy changes, and I think it’s going to just be phenomenal for clinical trials in general, but certainly for participants that were previously mis underrepresented in clinical trials.
Let’s shift a little bit while we’re talking policy, but shift a little to talking about Cancer Centers, specifically.
The National Cancer Institute expects Cancer Centers to engage communities within their catchment area, or the geographical area, from which hospitals actually receive patients. This is to decrease their cancer burdens, specifically among minority and underrepresented populations. Why is it important for Cancer Centers to consider this when they are writing their Cancer Center Support Grants? And how was this integral to this discussion that we’re having today?
John Stewart (16:56): Right, so I think that NCI Designated Cancer Centers must first and foremost impact the health of their catchment area. I mean that’s just the bottom line of what NCI Designated Centers need to do, and so I view this, kind of, as catchment-relative-research. And at the University of Illinois, we’ve actually written about the paradigm, in which we have community to benchtop; in other words, the needs of the community should inform the majority of the research that is supported by the Cancer Center.
Why is this important? Because it meets the needs of the constituents and it helps to improve the health and has a significant impact on the surrounding communities of the Cancer Centers.
Cheryl Byers (17:40): And this is really challenging though, for some Cancer Centers. So, could you suggest some efforts that they can take to enhance their minority recruitment?
John Stewart (17:48): Sure, so the first step for this, is actually creating a community advisory board, such as the one that we have in ChicagoCHEC. Because again, this gives the community a seat at the table, number one.
Number two is that we should actually have community partners involved in the design and conduct of clinical research, because, again, it gives them a seat at the table, but because it also helps the research team understand potential barriers from a patient standpoint that might impact enrollment, right? And so, it’s better to figure out those obstacles early in the process rather than later, when you’re trying to figure out why you’re not reaching your accrual goals.
The third piece, as I mentioned before, is to have a strong pipeline that includes members of the community.
Cheryl Byers (18:43): Yeah, that’s a really good point, and I know you know it takes a really long time to establish these relationships with community partners. This isn’t something that can be done over the course of, you know, six months or a year. So, it really takes someone who’s dedicated to putting in that time and effort, that sweat equity that you talked about earlier. You want to always engage those community partners and really establish those robust relationships and providing that information back to the participants is certainly an important step.
So, Dr. Stewart, when we last spoke, you talked about your framework of diversity 1.0, 2.0 and 3.0, and I found it very fascinating and I was hoping, you could tell our listeners a little more about this and how diversity 3.0 relates to policy.
John Stewart (19:28): So, you know this concept, this framework, was actually popularized by IBM and Dr. Mark Nivet, when he was at the Association of American Medical Colleges, published on this diversity framework. So, diversity 1.0 included efforts at removing social and legal barriers to access and equity with institutional equity and with institutional excellence. Diversity 2.0, actually kept diversity on the periphery, but it raised awareness about how increasing diversity benefits everyone and allows for excellence in diversity that exists as parallel lens. And so, diversity 3.0 is actually an emerging thought that reflects a growing understanding of diversity’s broader relevance to institutions and systems.
This includes policies aimed at enhancing diversity, equity, and inclusion in clinical trials, and in the training pipeline. It also includes policies such as the Clinical Treatment Act that we spoke about earlier, as well as the Henrietta Lacks Act. And so having these policies that also include monitoring funding for pipeline programs is going to be critical, because, as we move forward, we need to consider legislation that will bridge the digital divide, and I know the FDA’s guidance spoke about having electronic communications. And I think that there’s a real risk of the digital divide actually exacerbating inequities in clinical trial participation, due to an increasing reliance on electronic communication. And so the policy really needs to help us understand how we move forward within the role of diversity 3.0.
Cheryl Byers (21:12): Terrific, and I think that’s a good transition to talking about what the future is going to hold for diversity, equity, and inclusion in clinical research.
So with that, what do you think that the future does hold for DEI in oncology research specifically, but also just for clinical research as a whole?
John Stewart (21:31): Right, so I think that the emerging research around participation in clinical trials and oncology research and the continued emergence of value-based oncology, has actually set the stage for the future. And so, when we think about what we have to do to move forward, I think that one, we have to have more funding to support research that seeks to understand the structural barriers to clinical trial participation, I think, two, we need to have broad concerted efforts to enhance community engagement.
I think that having a couple of institutions do it really well is OK. But if we think about the Cancer Center Support Grants that are coming from the National Cancer Institute, is that community outreach and engagement are extremely important parts of those Cancer Center Support Grants, and in fact, community outreach and engagement needs to extend across the programs that are included in those CCSGs in order to really impact the health of the community.
I think, finally, we really need to think about how we improve the participation of underrepresented minorities and bio-repositories. If we think back to the Cancer Genome Atlas Project, I think that that project was slowed due to the lack of specimens from minority patients. So, as we think about moving forward, we have to understand how we increase the participation of all populations and bio-repositories and making sure that those specimens are well annotated and that we’re able to derive the maximal scientific knowledge from the specimens that are in the bio-repositories.
Cheryl Byers (23:30): Yeah, that’s a really good point. I think sometimes when we think about clinical research, you know, we’re not thinking about bio-repositories and so that’s excellent, I’m really glad that you brought that up.
And I hope I don’t throw you a curveball with this question but I’ve been an administrator of clinical research for a very long time, so I don’t have direct patient contact, I don’t have direct participant contacts, I’m not talking, you know, to individuals within the community, or even individuals that are recruited into clinical trials very often. So, what can administrators do to support the clinical research teams and clinical research investigators?
John Stewart (24:10): You know I think administrators are in a position to ask the hard questions. And so, if a person brings to you a clinical trial and you review it and you don’t think that it is set up to succeed, then I believe that is within your purview to ask the question, right? To ask the question around accrual goals, to ask the questions around clinical operations that are required to get a patient on the trial. I firmly believe that it’s going to take efforts from all fronts and clinical trials, not necessarily just the sponsor or not necessarily the investigator, but also the administrators, to make sure that everyone is on the same page moving forward.
Cheryl Byers (24:52): That’s great, yes, I’ve always taken the, “it takes a village” approach to clinical research so that’s a great answer and I’m very supportive of that theory.
Dr. Stewart, I just want to say thank you for having this conversation with me. It’s been really enlightening, and I very much appreciate your time, I also want to extend a thank you to all of those who are listening today. And did you have any parting thoughts before we wrap up our podcast today?
John Stewart (25:15): Cheryl, it’s been a pleasure and it’s candid conversations like these that are integral to DEI efforts that we’ve discussed today, and I hope sometime soon, we can have a conversation in person. So thank you so much.
Cheryl Byers (25:27): Thank you, I hope the same, and with that we conclude the second episode of it Advarra In Conversations With. If you’ve enjoyed today’s discussion, follow Advarra on our social media channels or on Advarra.com for our next episode.
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