Charting New Paths: Increasing Patient Representation in Genitourinary Malignancy Trials - Cheryl Lee

February 21, 2024

Alicia Morgans and Cheryl Lee discuss the need for equitable representation in clinical trials. Dr. Lee emphasizes the underrepresentation of minorities, low-income individuals, and those in rural areas. She highlights strategies for improvement, such as revising eligibility criteria, reducing the burden of trial participation, and employing patient navigators. Dr. Lee also mentions the importance of tracking and reporting demographic data to enhance inclusivity. She suggests that trials should prioritize high-risk groups, like African American men in prostate cancer studies, to ensure their significant inclusion. Dr. Lee calls for collaborative efforts and the use of resources like patient navigation to facilitate broader participation in clinical research, aiming to address disparities and improve outcomes across all patient groups.


Cheryl T. Lee, MD, Urology Specialist, The Ohio State University Comprehensive Cancer Center, Columbus, OH

Alicia Morgans, MD, MPH, Genitourinary Medical Oncologist, Medical Director of Survivorship Program at Dana-Farber Cancer Institute, Boston, MA

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Alicia Morgans: Hi, I'm so excited to be here at GU ASCO 2024, where I have the opportunity to speak with Professor Cheryl Lee, who is the chair of the Department of Urology at Ohio State University. Thank you so much for being here.

Cheryl Lee: It's wonderful to be here. Thank you for the invitation. This has really been extraordinary to present some of our thoughts and reflections at GU ASCO.

Alicia Morgans: It's such an honor for us, I think, to have you as the keynote speaker, really speaking to us about social determinants of health and how we can think not only about survival curves in the medicines or the surgeries or the radiation that we're delivering but actually how we get that to patients and how patients engage across the healthcare spectrum. I would love to hear some of the details of your talk.

Cheryl Lee: Sure. And I think, first, in approaching this discussion about representation in clinical trials, it's so important for people to understand that they shouldn't be overwhelmed by it. It's one of those challenging areas that I think many of us have faced and not always appreciated how to move things forward. Part of the reason I was thinking about this topic, and it really dates back to 2016 when I was on Subcommittee A, when I started on Subcommittee A of the NCI. And that committee was charged with reviewing the Cancer Center Support Grants for NCI-supported cancer centers across the US. As part of that work, you really understand the expectation that the NCI has for its cancer centers to deliver equitable cancer care to the individuals within that center's catchment area. Part of that relates to accrual to clinical trials because we know how important it is.

We know that if you're part of a clinical trial, one, you have the opportunity to have close follow-up. You have the opportunity to access novel treatments that you probably couldn't get elsewhere. And the people that are participating in clinical trials actually have better outcomes when they're compared to those who are non-participants. So the NCI wants to make sure that the patients who are accrued to those trials really reflect the population of the catchment area. As I thought about some of the challenges we face while I was on that committee, and since then, although we've made progress, we still have some real under-representation of many patients that we know are affected by cancer health disparities. And who are those people? Those are racial and ethnic minorities, individuals' sexual and gender minorities, low socioeconomic status, patients with disabilities, patients in rural populations. And I could continue, patients at either spectrum of the age continuum. So those patients really are the ones that I think we're doing a disservice to when they're not part of a clinical trial.

So part of what we discussed today was the importance of representation. But two, how should we be thinking about representation? What is the right proportion? Should we be thinking about it from a population context or a prioritization context? We also talked about some real practical tools that we as clinician-researchers can use to increase our accrual of underrepresented individuals. And also thought about what we are doing specifically in genitourinary oncology to move the needle. Particularly as we partner with some of our global partners around the world. And you wouldn't know it, but we really are the group bringing diversity to a number of these very important paradigm-shifting global studies. And we need to see ourselves in that way. We are the site that is going to intentionally make sure that there's a diversity of patients within the studies and a diversity of related specimens within the studies because that's important too. That's a downstream effect of being in a clinical trial, the related correlative science.

And if we think about it, those really precious specimens that are well characterized and part of a clinical trial, with those tissues, we really understand the mechanism of disease better. We generate hypotheses. And ultimately, we're looking to create new therapeutic strategies. So if you're not part of the trial, you're not part of the correlative science, which means you are not fully included in all of the downstream effects of that.

Alicia Morgans: So knowing that and sharing that information is absolutely step one, the awareness and understanding of the importance. But I love the way you frame us as having the opportunity to really drive this in the trials that we lead, the ones that we work together with, whether academic, pharmaceutical, device, or other colleagues. But how do we, in real ways, actually do that for those of us in the community? And I'm sure and hopeful that it's growing, that they're really thinking about this and making sure that there's a place for everyone in these trials.

Cheryl Lee: This is a wonderful question because I think we get lost sometimes thinking about some of the areas that it's harder to control. Garnering trust in patients, we're all working towards it, but we have challenges there. We have real ways to improve the accessibility of our trials. One, we can start by making sure when we approach partners to be part of our new trial, that we're thinking about the contributions that those sites can make, that those partners can deliver on. Some of it, in my mind, should be based on the prioritization of the patients within that disease site. So, if there are patients that are higher risk, let's just take prostate cancer for example. And if we know that African American and Black men have a higher incidence and higher mortality rate, whether you're talking about localized disease, regional disease, or distant disease, we think of that group as a priority group.

And rather than looking at meeting a census or population-based benchmark, or the accrual of those patients in a trial, we have to really think that those patients need to be a majority partner in those trials. So, as we're looking for sites, for example, we need to think about sites that are going to be able to accrue those high-risk patients. We also need to think about how we are writing trials and what our protocols look like. What eligibility criteria are we including in our trials? Are they unnecessarily restrictive? If we have challenging eligibility criteria, particularly without scientific justification, that can potentially disenfranchise many populations from participation. So, as we're writing, we need to think about the eligibility criteria. And ASCO has done a great job partnering with the Friends of Cancer Research to really think deeply about several areas and make specific recommendations that can increase the accrual of patients.

We also need to think about the burden of participation in trials. And we are writing those protocols, and we have some control over that. We were able to connect with our patients and still advance our clinical research during the COVID-19 pandemic. And we did that by being resourceful, but we also did it by being patient-centered. Electronic consents, telehealth to engage patients in regular visits, and a number of activities like that. So we don't need to wait for a pandemic to make life easier for our patients to participate. So I think we can reduce the burden of participation. And again, we have control over that. The other, I think, opportunity that we don't always take advantage of is the use of patient navigators. And particularly in under-resourced settings and working with underrepresented minority patients, patient navigators can increase the accrual of those patients and the enrollment. And also, the sustained nature of those patients throughout the trial. So allowing them to actually finish the trials.

So just recently, CMS reported a rule about allowing reimbursement for patient navigation services. So this is the time now for us to consider expanding our team of patient navigators who are effective at helping patients manage critical and major health conditions like cancer. They also were effective at helping people to get into and stay in clinical trials. So this is the time for us to talk with the CEOs of our cancer hospitals to ask to expand our patient navigation workforce. So these are some of the things that we all can work towards. Not only that. For those of us who are actually engaged currently in a trial and trying to recruit patients, we can ask ourselves, are there any others we can partner with to help strategize about enriching the trial with the patients we need? One, some people have gone to including a DEI co-chair within trials, and the Alliance has done something like this. And that can just help people think about these issues as they're happening in real time.

But many of us are part of cancer centers that are supported by the NCI. So there are certain services that are required to have that designation. Are we partnering with our community outreach and engagement programs? Are we leveraging that team to connect with community advisory boards to engage the community, understand the concerns that the community may have? But also have those teams increase awareness about specific trials that would be relevant to those communities. So there are certain resources I think we have access to that we haven't always utilized. The other potential partners are our disease-specific research groups at our cancer programs. We get a little bit siloed in our disease settings and don't leverage some of the services that some of our peers can bring. So I think these are all really very specific things that we can all do. Lastly, I'll mention just an issue of tracking data and reporting data.

You would be surprised to know that many large studies are not tracking some key demographic elements in 2023, including race and ethnicity and even geography. So it's hard to improve our accrual if we don't really understand the baseline accrual that we have across populations. And again, particularly for a given disease, we need to think about the patients at highest risk. And how are we doing in incorporating those patients in those trials, so we can learn more about their risk. So the concept of tracking these elements and then reporting them and having organizations like ASCO set an expectation to have that reporting when an investigator is submitting an abstract or a manuscript. So these are all very practical things that I think many of us could do. We all wear many hats. So I expect that it would be challenging for everyone to do all of those things, but we need to leverage the tools around us and the people around us.

Alicia Morgans: Speaking of the people, because this is a multi-team, multi-person sport, I guess you could say almost. I mean, clinical trials are an endeavor that takes so many resources. And I so appreciate you laying out our need to engage and really ramp up some of the resources that we are all actually entitled to or at least should be engaging, especially as we're cancer centers designated by the NCI. What other solutions do you have for us as we start to wind down, and where do we go in the future? How do we ultimately find success?

Cheryl Lee: I think one, as we're putting trials together, I would love for all of our clinical trials consortium groups to think about this concept of having co-investigators that are thinking about some of these issues. Whether you call it a DEI co-investigator or someone who is there to have at the time that studies are being discussed, at the time that sites are being engaged, at the time that eligibility criteria are being developed, that protocols are being written. Having someone as part of the group to consider how we can really think about underrepresented populations and who can partner with us and deliver on accrual. So I think that's something from the context of NCI-supported trials, especially through the cooperative groups. But even in our local institutions, having a partner again may or may not be within GU. Maybe within the cancer health equity group, maybe within another organ site.

And someone has helped to facilitate these kinds of meetings, partnerships, discussions, and resources. So I think starting with some of those partnerships is important. I think really just being intentional and thoughtful about the work we put forward and what we expect patients to do. And if we approach every patient as one who may be negatively impacted by social determinants of health, I'm sure they would all appreciate it. Because even if you aren't directly affected by a social determinant, you still would rather not have five or six extra meetings or patient visits. You'd rather do that at home from telehealth to answer those questions or surveys. So I think these are some initiatives that could raise all boats, so to speak.

Alicia Morgans: Wonderful. As you think about all of the things that you're doing, is there anything else that you want to mention that we should have top of mind as we consider these issues in our clinical trials and practice?

Cheryl Lee: Well, I do want the audience to know that these issues have risen really to the top of our national leaders' attention. And we have a number of reports coming out from the FDA, from the National Academies of Medicine to really think about strategies and solutions. We're not alone in trying to improve this issue. I think many understand the importance of it. And the NCI has funded a UL1 mechanism called CUSP2CT, which is connecting underrepresented patients to clinical trials. And there are four groups working as part of this mechanism. We have a project at The James and The Ohio State University Comprehensive Cancer Center. This initiative is important because it's really trying to generate evidence-based strategies and interventions to improve referrals of underrepresented patients. And also, accrual and enrollment of these patients into NCI-supported trials. So we are on the cusp of developing the kind of evidence that I hope will then be exportable to other cancer centers around the country and perhaps beyond.

Alicia Morgans: So, I am just so impressed and so appreciative of the contributions that you certainly made to GU ASCO 2024 with your conversation. But also, with the work that you continue to do at your local center and at a national level as well. Thank you so much for talking through this with me today. I really appreciate your time.

Cheryl Lee: Thank you.