19 – The Power of Diverse Representation in Clinical Trials
March 25, 2024

Diverse clinical trials provide more meaningful data to researchers, but too many trials are based around monolithic audience groups. In early disease detection, particularly in conditions like cancer, diversity in clinical trials is especially important. Our guests, Eucharia Borden of the cancer nonprofit Family Reach and Dr. Gary Puckrein of the National Minority Quality Forum, discuss why diversity in clinical trials is critical and how to foster inclusivity in clinical research, getting us closer to healthcare equity.


Kim  00:08
Welcome to The Cancer SIGNAL, a podcast presented by GRAIL, where we discuss the impact of early cancer detection, the science behind multi-cancer early detection and insight into how this approach has the potential to shift the cancer paradigm. I’m your host Kim Thiboldeaux.

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Today we’re going to discuss diversity in clinical trials – what it is, why we need it and how to achieve it. With us today is Eucharia Borden, Vice President of Programs and Health Equity at Family Reach, a nonprofit organization that provides financial support for families facing cancer. Eucharia has dedicated the last 16 years of her career to the oncology field working in patient advocacy and direct social work practice within acute inpatient and outpatient hospital settings. She is a past President of the Association of Oncology Social Work, and a recognized AOSW fellow. She is also a former Vice President of Health Equity at the Cancer Support Community. And I’m happy to welcome back to the podcast Dr. Gary Puckrein, who is the President and Chief Executive Officer of the National Minority Quality Forum, a not-for-profit organization that he founded in 1998. NMQF addresses the critical need for strengthening preventable illness in minority populations through prevention, early detection, and control of disease complications. Welcome to the show Eucharia and Gary.

Gary and Eucharia  01:42
Hello. Hello.

Kim 01:43
Well, Eucharia let’s jump in. Let me start with you. Let’s just start with a moment for you telling our audience about Family Reach. What do you guys do at Family Reach? What is your mission?

Eucharia  01:52
Absolutely. Thank you so much for having me today. What we know is that the financial burden of cancer is a life or death problem. And so our mission at Family Reach is to remove the financial barriers that stand between a cancer patient and their treatment. We are a nonprofit that provides non-medical financial support to families facing cancer. And we’re specifically focused in four areas. That’s food, transportation, housing, and utilities.

Kim  02:26
Excellent. What’s your website, Eucharia where folks find you?

Eucharia  02:28
We are at www.familyreach.org.

Kim  02:33
Perfect. Gary, tell us about the National Minority Quality Forum and where folks can learn more about you.

Gary  02:37
Great. So the National Minority Quality Forum. We are a research and education organization based here in Washington DC. Our work really starts with data collection. So we’ve been collecting health data now, for about 20 years. We have a database of over 5 billion patient records. We collect data on about 160 million lives a year, covering well over 100,000 different conditions. So we actually know where care is being delivered, who’s delivering it, what the outcome is.

Kim  03:10
Perfect. So you’re the perfect person to help us through this conversation today. Along with Eucharia. Eucharia, let’s start with some basics. How do we define diversity in clinical trial recruitment? What does a diverse study look like?

Eucharia  03:23
When I think about diversity in clinical trials, I really literally think about having people invited to participate who have a variety of backgrounds, whether that’s racial or ethnic, socio economic, but also a diversity in lived experiences as well. You know, it’s really thinking about doing some work before the design of the trial. Because we really need to understand whether we’re looking at cancer or another diagnosis, who is most impacted? Yes, that’s something to look at. But who is also most disproportionately impacted. Those things need to be taken into consideration as the trial is being designed in the first place. You know, I think an example that I think about all the time is when we look at heart health. For years, we focused research on men. And what we now know is that women have very different signs and symptoms of a heart attack. And it’s a great example of why we really need to think about not just who to include, but who’s being excluded from the design of a trial.

Kim  04:34
Great, great. Gary, we know that many perhaps most trials struggle with diverse recruitment of trial participants. Let’s talk about why that is and talk about why inclusion of all groups in clinical trials matters – not only things like race, age, gender, but socio economic and, and geographic diversity and what else should we be looking at Gary?

Gary  04:55
Well, just to build on what Eucharia said, I mean, here’s the deal. Um, heterogenetic, diverse trials, you learn more about the disease, the therapy than if you have a trial that’s just made up of a single group. The smart way to learn is through understanding how diseases present differently, and also how medications are present for populations. So why do we have this trouble getting our clinical trials diverse? And we have to be candid, you know, our healthcare system really was rationing care. I hate to use that word, but that’s what it was doing. And so, back when we got started, minority populations, poor populations weren’t really invited into the clinical studies. You know, that’s changed now. But those patterns are hard to break. So when you go into a poor community, for example, you find that they’re not being invited into the clinical trials that historically there are all kinds of concerns that the PI, the principal investigator, of the study might have. You know, I know back when we got started, because we didn’t have universal health care, a plan would say or innovative company would say, well, they can’t use of medication after the study is over. If so, why would I, why would I diversify my trials? But fortunately, that world is changing dramatically. And we’ve got a better understanding of the opportunity that clinical trials present. Also, the fact of that, you know, we are building infrastructure in these communities that allow us to diversify our trust.

Kim  06:59
Gary, are there examples of you know, when trials have failed to diversify their recruitment? Has it? Has it impacted results or rollout? Or can it? I mean, are we looking at sort of missteps, when we don’t have that representation in trials?

Gary  07:13
I’m going to give you the, what I think was a great example of breast cancer. And this is an actual story that happened with my staff. So one of my staff persons gets a call from NIH, about participating in a clinical trial, a breast cancer clinical trial. And she goes through the protocol and at the end of the study she’s told she didn’t qualify. So if you know my staff, they’re kind of pushy, so she says, ‘What do you mean I don’t qualify? I’m like ground zero for breast cancer.’ And so the person who was doing the interview, decided that well, give me give me a moment here. So they went back into the study, and they unchecked the box that she was African American. And the minute they uncheck the box, she was eligible for the trial. So guess what, when they started to use the medications that came out of those studies, on African Amer- it didn’t work. Right? Because the trial was set up that way. And so there are lots of examples in which, because you didn’t diversify the trial, historically, the way it worked was, you got it through FDA, the medication through FDA, and then in clinical practice, you made the determination by physicians in clinical practice, say, Oh, I use this drug on my patient and it didn’t work or they had an adverse reaction. That’s how this data got collected. But that’s no way to run a ship. That’s how it works.

Kim  09:08
Wow. Wow, some shocking data there. For sure, Gary. Eucharia, so let’s talk about some of the challenges involved in diverse clinical trial recruitment, how can that be overcome? Some examples, you know, can study site location impact diversity? What are the other barriers that exist to diversifying trials?

Eucharia  09:30
Oh, absolutely. If we think about trials that are being run out of academic medical centers and cancer centers versus those that are coming out of community cancer centers and programs, we’re looking at different populations of people, people who have very different kinds of lived experiences. And you know, I’m a person who lives in a big city with lots of academic medical access here. That is not the case across the country. In fact, more of the United States is rural than not if we really think about it. And so things like transportation, remember I said Family Reach is really focused on meeting patients’ basic needs. And we work to challenge the systems that force families to choose between their health and their home. You know, I was talking to a colleague recently, who was telling me that she works with patients who sometimes choose hospice, because that’s the easier choice. And when I heard something like that, I mean, it literally broke my heart to hear that. And when I probe to find out more about that, she said, getting to treatment is a problem. It’s too much, it costs too much, the access is not there, the support system is not there. And I think for a while, we’ve talked about things like social determinants of health, sort of with this 30,000 foot view. But what does that really look like in the life of a person who’s considering enrollment on a trial? You know, Gary alluded to many issues there, right? So first, there’s, can this person enroll in this trial? Because there’s so many exclusionary criteria. But let’s say that a person has been told they do qualify, they are eligible. At that point, there’s still some decisions that have to be made that haven’t always been discussed. I think transportation comes to people’s minds the most because it really is about access and getting to a trial. We know that there are people who are making choices every day between things like, do I pay to get to my treatment or to my trial? Or do I put food on the table? Do I, do I consider what my children need? Or the guilt that I’m personally feeling? Because I’m putting myself above my family? Now, certainly, that may not be what I would think that is. But these are decisions that people are making. If we are not meeting people’s basic needs, and taking those into consideration when we’re designing trials, where do you go for your bloodwork? Where do you go for the appointments? How are people managing that? People are finding it so hard to manage just the daily ins and outs of treatment, and then layer on what’s needed for access to a clinical trial. And it can feel impossible to even participate. And we’ve been fortunate enough to have conversations, not just with providers, but with patients also to say, hey, wait a minute, please pay attention here. I need some help.

Kim  12:32
Or even things like you’re suggesting Eucharia, things like child care.

Eucharia  12:39

Kim  12:39
Who’s going to take care of the child, right?

Eucharia  12:40
Exactly. I mean, these are these are real issues for people.

Kim  12:44
Or folks, they don’t work, they don’t work, they don’t get paid.

Eucharia  12:46
They don’t work. They don’t get paid. They don’t have the childcare. You know, I’ve even and like I said, I think transportation is the thing that people talk about the most, because it is the most concrete thing that comes to mind. But I really see transportation as a gateway problem. If I can say it that way. If someone is having trouble with transportation, we need to be asking some additional questions, because what usually follows are other issues that we need to attend to in that person’s life.

Kim  13:16
Yeah, it’s a symptom, really, symptomatic of other things for sure. Gary, previously, you mentioned the FDA, obviously a critical player in this conversation. I know that there have been some changes in FDA guidelines around diversity in clinical trial recruitments. And the sort of plans that the manufacturers are bringing forward What are they requiring now? How is that going? How is it being enforced? Give us an update there, Gary.

Gary  13:42
So FDA has passed some new rules that require diversity in clinical trials. But let’s take a step back for a second to understand the import of those of those rules. So America is changing, right? The demographic shift is in full blossom. The majority of people under the age of 18 are minority. If you start a clinical trial today, by the time that medication or device or whatever it is comes to market, of the majority of the population is going to be a diverse one. And so diversity in clinical trials is not a nice to have. It’s now critical to the American healthcare system, and FDA understands that. So what FDA has said that everyone who is presenting to get licensure for either device or drug presents to FDA, they must have a diversity plan. That diversity plan needs to say – so here’s my understanding of the population that is going to use this innovative therapy, whatever the therapeutic area is. And here’s my plan for reaching out to ensure that my, my trial is mirroring the population of that I understand will use that medication or device. And so that has an important impact on innovative companies now, because they are now thinking about diversity in a way in which they haven’t had. Now I would make the argument that well, we can put a little bit more teeth into that in terms of, of requirements. I personally don’t look to quotas, but really try to figure out, how do we incentivize? Because when we had this problem, for example, with children, those who were developing medications did not like to do clinical trials in children, as you might understand why. So we had the pediatric exclusivity provision, pediatric exclusivity provision. So what that basically said is, we will extend your patent life for six months, if the, if HHS asks you to diversify your clinical trials, you can go back and forth by what’s asking. But nonetheless, the point is, you don’t have to worry about it anymore, right? Because that’s while we were looking at orphan drugs, right? We did the same thing with orphan drugs, we use market exclusivity, to entice innovators to create orphan drugs. An orphan drug is population of about 200,000 people near about with a particular disease, we’re not producing, we’re not producing a lot of medications and interventions for them. Now, orphan drugs lead the marketplace. Because the innovative companies understand that there’s a unique benefit to providing for that population. So my point is that market exclusivity, there are ways to incentivize the business community because at the end of the day, that’s who they are, into tackling a problem. I think that’s the way to do it. I think you can lay down a lot of honey, they’ll figure out how to get the honey. You don’t need to be prescriptive and say I order you to go do this. But nonetheless, you can set it up so that it’s in their interest to go do it. And I think that’s where we’re headed.

Kim  17:44
But Gary, don’t we also have to encourage them to create meaningful partnerships?

Gary  17:49
Absolutely. Absolutely. So let’s talk about that for two seconds. Because it’s really, it’s really, it’s really important. So FDA created this new demand for diversity in clinical trials. And so you have a lot, you have new energy, let’s put it that way, going into underserved communities for clinical trials. But they’re not putting infrastructure there. They’re not they’re not bringing those communities in. They’re extracting, right, information and data. But they’re not transforming those communities, by putting clinical trial infrastructure, by taking FQHC federally qualified health clinics, for example, and making them research centers or community clinicians and empowering them to do studies. No, basically, it’s like, it’s exploitive. Let’s put it bluntly, right, because you’re extracting, but you’re not returning value. And right now, clinical research is about $245 billion annual business, very little of that is getting to underserved communities. And that’s important.

Kim  19:03
So we have to, we have to teach a man to fish instead of giving them a fish.

Gary  19:07
Absolutely, that’s what’s good, because then it overcomes all of the suspicions and anxieties, because it’s people in the community, understanding the value of clinical trials, both in terms of clinical as well as, I think it’s an important way to really think about the problem.

Kim  19:27
And it benefits the science because we’re building infrastructure to accelerate the research, right?

Gary  19:31
Exactly. And also preparing people so that now they understand the science, right? It’s not a foreign tool. You know, so there’s really, some real thought has to go into this. I think it’s happening, but I think that’s the transition.

Kim  19:45
Good, good. Well, I know you’re a leader in that conversation, Gary. Eucharia, so what can people look for when they hear about a study, whether they’re a person considering participating in a trial or want to understand a trial? Look at the findings of a completed study to determine, you know, whether a trial has a diverse pool of participants, what are those hallmarks that people should be looking for?

Eucharia  20:08
Number one, people need to be asking questions of their providers. And I find that this doesn’t happen as routinely as it should. You know, when you think about people who’ve had poor experiences in healthcare, one of the things that persists is this power differential, where people feel like they can’t ask questions, they can’t question things. And we need to be asking questions. So when someone presents a trial, one of the questions that a person could ask is, well, who are the participants? What are the recruitment strategies? Where have you been recruiting from? That’s the part of the conversation that doesn’t take place. A lot of times the conversation is focused on the things we would expect them to be focused on. Things like, you know, what is the purpose of the study? How is it designed? You know, is there a placebo? Which is a question that patients often have. You know, what are the anticipated side effects? Like those are the usual conversation questions that tend to come up. But what about the things I was talking about earlier? The personal impact, ask those questions as well. So we want to know, not just that I have to be there for these appointments. What is the length of this study? Whether this, is this six months? Is this two months? How often do I need to be somewhere? What is covered under my insurance for this trial? What is covered for the standard care of this trial? You know, it’s hearing information and taking it upon ourselves to dig deeper, because information about who’s in a trial hasn’t always been available, we’ll see how that changes under the FDA guidance. I mean, I read a lot in there about the guidance, but how readily available that will be remains to be seen. And so it’s even making ourselves aware of the fact that there is FDA guidance about diversity in clinical trials. Essentially, what I’m saying is, as a consumer of healthcare myself, as a person who’s come alongside family members who’ve had cancer, one of the things that they’ve done is to become a bit more educated about how this process works. And it’s not to say that people aren’t educated. I don’t mean to say it that way. What I’m saying is, it’s just understanding that this is a two way, bi directional conversation that should be taking place, and that it’s okay to not be sure, it’s okay to have those questions. Quite frankly, when we think about experiences that people have had in healthcare and we think about things like medical mistrust that exists, it’s because our providers haven’t historically done a great job of earning that trust. And so when providers are working with patients, why not just be upfront, right? I mean, that’s a novel idea. Just be upfront with people to talk about if there is not a diverse representation. Why is that? When we think about strategies, I remember talking to someone who was designing a trial, and they were talking about how we’ve actually had so many efforts, we’ve reached out, there were so many people who screened out who were black or Hispanic. Here’s what happened to those patients. And I thought, but why is that being shared in this closed setting? Why are we not being upfront about that? You know, as we think about that lack of engagement in a community, these are the kinds of conversations we should be having.

Kim  23:47
Yeah, absolutely. Absolutely. We’re getting to the end of our time together. I have so much more I want to I want to talk about but I’m gonna bring the last question to you, Gary, and Eucharia began to touch on, I think it’s important to reinforce is that issue of trust. And there has really been a breakdown in trust between communities of color and the research community. We know some of the reasons for that – Tuskegee – there are a whole host of sort of historical breakdowns in that trust and violations. Egregious. But Gary, what’s happening? What are we doing to build for providers and researchers to build back trust with communities of color, marginalized communities? What steps are being taken? What examples can you give that are moving us in a better direction in that piece?

Gary  24:29
I can talk directly about what the National Minority Quality Forum is doing. So we actually published an article with Dr. Janet Woodcock when she was acting commissioner of FDA, and actually, it was part of conversations that she has been having for a long time, which is we need to train community clinicians to be principal investigators in clinical trials because they have the trust of the patient already, the patient comes into their, into their practice. And so the problem has always been sending them out of that practice in order to get them in clinical trials. But the problem with those community clinicians is that they’ve not been trained to do clinical trials, they don’t have the infrastructure and resources to do clinical trials. So we, based on that article, we launched something called the Alliance for Representative Clinical Trials, in which we literally train community clinicians to do clinical research. We bring them into a network, and we find trials for them to do and they are essentially recruiting their own patients into clinical trials. And it goes very well. I think that’s an example of putting infrastructure into those communities. That is probably the most important thing that we can do is to build infrastructure into those communities, and bring them into the research process.

Kim  26:08
Where there is the trust, where folks have their medical home, where they’re comfortable, where they see people that look like them and are having the same experience. Yeah, that’s great advice and congrats on that work you’re doing. I want to thank you both for joining us today. It’s really been a terrific conversation. I think we could go on for two more hours on this topic. There’s so much to uncover, but I appreciate the examples that you’ve shared. Appreciate the work that you’re both doing to help us make progress in this area, such a critical area of the scientific conversation. So thank you for joining us today. This is The Cancer SIGNAL presented by GRAIL. I’m Kim Thiboldeaux. Please rate and review our podcast and be sure to subscribe to learn more about the impact of early cancer detection on future episodes.