Expanding Diversity in Clinical Trials…

This week, Jeremy welcomes Dr. Terry Heiman-Patterson, professor of neurology at the Lewis Katz School of Medicine at Temple University and director of the Temple MDA/ALS Center of Hope, to talk about her work looking into ways to expand access to clinical trials for historically underserved populations.

 

Learn more about The ALS Association’s Clinical Trial Capacity Awards program at https://www.als.org/stories-news/als-association-grants-nearly-5-million-boost-clinical-trial-capacity-and-speed

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Connecting ALS is a weekly podcast produced by The ALS Association in partnership with CitizenRacecar. We aim to discuss research and technology developments, highlight advocacy efforts, and share the personal stories woven through the community.

Terry Heiman-Patterson:
Part of our program is really understanding intrinsic bias and actually starting with analysis of ourselves and where our intrinsic biases are, because we have to acknowledge, and we all have them. It's nobody's fault, but you have to recognize them and try to overcome these biases that we're all ingrained with.

Jeremy Holden:
Hello everyone, and welcome to Connecting ALS. I am your host, Jeremy Holden. Expanding access to clinical trials is crucial to making ALS livable for everyone everywhere, and that includes making sure people from historically underrepresented communities are able to take part in clinical trials. If clinical trials only include a narrow population, results might not accurately reflect the real-world impact of treatments on everyone. The effects of drugs and treatments can vary depending on factors such as age, sex, race, ethnicity, and other demographic characteristics.
So without including a diverse population in clinical trials, researchers can't fully understand how a treatment works in different populations. That can lead to unintended consequences, including adverse effects or lack of effectiveness in certain groups. Increasing diversity in clinical trials is a real challenge for investigators who are designing the trials. Language barriers, cultural beliefs, and socioeconomic factors could hinder participation in clinical trials. A lack of diversity in clinical trials can limit the generalizability and applicability of research findings to diverse populations leading to inequities in health care outcomes.
We talked earlier this year about the ALS Association's clinical trial expansion grant program, and one of the projects funded through that program is looking at ways to overcome barriers to diversity. I had an opportunity to talk to the lead investigator of that research, Dr. Terry Heiman- Patterson, Professor of Neurology at the Lewis Katz School of Medicine at Temple University, and Director of the Temple MDA/ALS Center of Hope. Well, Dr. Heiman-Patterson, thanks so much for being with us this week on Connecting ALS.

Terry Heiman-Patterson:
Oh, it's my pleasure. My pleasure.

Jeremy Holden:
Yeah. We're going to get into some specific research that you're spearheading up there in Philadelphia. But at the outset I want to get a sense of the problem that you're trying to solve. So what are some of the main barriers to expanding access to clinical trials?

Terry Heiman-Patterson:
In terms of including underrepresented individuals, and this includes both ethnic and racial communities that are less representative in not only clinical trials but also in our clinics and in obtaining care. And that's one of the issues, is what are the problems? Some of them relate to intrinsic biases of physicians both in the community and in the clinics, quite frankly, and understanding intrinsic bias and addressing that.
And then there's the social barriers, the things that we all think are at the root cause, but may not be the whole story. And that's, "I have to work, or I can't keep my insurance, and I can't take a day off of work to go to the doctor. I don't have the money for the copay. I don't have anyone to babysit. I don't have transportation to the clinic. I can't afford the parking." The issues go on and on. And we tend, I think in a biased way, to say, is call people out, "They're not compliant. They've got an appointment."
We're not addressing, not reaching out and finding out in an individualized way what those barriers are. And then there's also probably some level of mistrust, and so we have all of these things. And different populations probably have different core cultural differences that make the barriers different within each group. So understanding that one size doesn't fit all is an important part of my approach.

Jeremy Holden:
You mentioned that term, intrinsic bias. So we're talking about biases that are kind of baked into the cake. They're kind of part of the system as it exists, and we may not be aware of them.

Terry Heiman-Patterson:
And part of us. These are intrinsic biases we all carry and don't even recognize it. So part of our program is really understanding intrinsic bias and actually starting with analysis of ourselves and where our intrinsic biases are within my core group. Because we have to acknowledge, and we all have them. It's nobody's fault, but you have to recognize them and try to overcome these biases that we're all ingrained with.

Jeremy Holden:
I have an intuitive sense of the why here, but I think it's worth exploring. So an obvious why is that there are people who need care, who need access to clinical trials, and let's make sure it's available to them. But from a scientific perspective, from a bettering, thinking specifically of clinical trials, how does it benefit clinical trials to be more expansive?

Terry Heiman-Patterson:
Has to be. Because when you make the assumption that a drug or an agent will work the same in every population, that really is an assumption that you can't make. Some of the things that make us different are our genetic background. That may also alter our response to a particular medication. So I think that from just the standpoint of safety and understanding drugs in an entire population, you have to understand the way it responds in all elements of the population, which includes not just one group.
And there are biases in who joins trials. That's a problem. In our center it's like mainly the really educated activist type of people who look at if they want to do things. And so there's cultural, and then there's also intrinsic personality traits that are going to lean towards who joins a trial. But we need to understand how drugs work in the entire population, and then just out of fairness everybody should be given opportunities.

Jeremy Holden:
One of those SAT words that I think the entire population that we serve understands is heterogeneity. And with a heterogeneous disease like ALS, does it become even more important to when you think about getting a representative sample that you are thinking inclusively so that we are sampling and testing therapies on a diverse population?

Terry Heiman-Patterson:
That's pretty funny because we're in an age of actually trying to be more personalized and really highlight responder population and understand through biomarkers in other ways if I have a particular drug who is predicted to respond. And it becomes especially important in newer drugs that we want to detect a response to get things approved and out there. Then we could worry about the entire group, and does everybody respond? But there may be particular responder populations for a drug. For instance, if I have a drug that modifies oxidative stress, people whose disease is driven by oxidative stress may be the ones that respond best.
Doesn't mean others won't respond, but they may be the ones that respond best. And in order to get things to market faster and to get things out there faster, you want to detect a response as fast as possible, you're going to want to detect responder populations. The second parallel to that is, you don't want to be giving drugs to people who aren't going to respond to it. These are going to be expensive drugs. So you also want to understand who's going to respond. So while you start with a responder population, you need that wider group to see will everybody respond or is it only certain people respond, and make sure that we're able to identify who should get that drug.
Almost the state we're in in cancer now, your receptors, if you have receptor positive ABC you get this drug. We have to get there with ALS. But the first step is figure out a responder population. But the second question is, "Okay, what about the rest of the population?" And the rest of the population includes everyone. When I say everyone, it means we have to respect the disparities and get people into trial who might normally not be in trials. There's also another element, which is education about research and understanding why do research, why you should participate. We're not experimenting. We are experimenting, but not like a rat.
We're trying to make progress on the disease. Programs like the Clinical Research Learning Institute pioneered by Dr. Bedlack, these are great programs, but we got to bring it to the communities that aren't coming to those programs. And we have to talk in a way that folks understand. And that doesn't mean ... I'm not talking about simplifying, I'm talking about in their language, the way they understand and think about life. So we have to have an appreciation for other cultures and the diversity, and we should actually celebrate diversity.

Jeremy Holden:
Yeah. Yeah. So thinking about that as celebrating diversity and trying to, diversifying the pool of folks who are participating in clinical trials and who are accessing the clinics that they need to access, how is the ALS Center of Hope going to go about tactically reaching out to historically underserved populations?

Terry Heiman-Patterson:
Luckily, we sit in a area of traditionally underserved populations, Latino, Black, Asian communities, and now immigrants and displaced citizens from other countries that settled here of late. The school itself has a huge public health program that is directed at really identifying and engaging these populations. I'm going to leverage those relationships in order to really have a two-pronged attack. That two-pronged attack, one is you've got to educate the clinicians in the community, in those communities, about in this case ALS, and why you should make the diagnosis early and what should clue you in.
I think that, unfortunately, people have the notion or the idea that ALS is untreatable, and so there's no rush to get people to the clinic, and not much is going on. So we have to educate that, A, for good care you need to get people to the clinic. We have drugs that slow the disease down. And starting them later rather than earlier isn't as good. That if something slows the disease down, the sooner you start it the better. We have to educate them on when to think ALS. The ALS Association has done a very good job with their thinkALS, but that actually has to get out to those community physicians so that they understand it. So at least locally here in Philadelphia, I want to get that message out to folks through educational programs.
And then the promise of new drugs, and educate them on why they should encourage folks to join trials. It doesn't keep you from getting the best care possible and the drugs that are available, but will help us get to the next level in treatment. And then we have to go out to the community, and I've already started to go out to community fairs, health fairs, and educate people about these diseases, and about ALS, and about the importance of, this can touch you. The first thing I say is, "It's fine. You can ignore me and think it'll never happen to me." But each of us has a one in 400 chance of getting ALS, number one.
Number two, when we think of it, why go to a specialized clinic and why join in research, and in a way that the community can absorb and understand. I have to talk their language. We're doing that. We're also doing some events that are designed to raise awareness about ALS and even neurodegenerative disease. We're doing a concert, it's a Latin concert that's all in Spanish. It'll be basically all compositions by Latin composers and celebrate the Latin heritage. And at the same time we'll be talking about ALS neurodegenerative disease, and we're going to be giving out materials that is in both Spanish and English about ALS and some of these concepts.
And so getting out in the community, we're going to be talking on the radio. There are ways to get out in the community, churches and community organizations. So we've started to reach out and make connections. And we're hiring. Or the way we're doing it is hiring. You're asking me how are we doing it? We're going to the community. We're teaching folks who take care of patients in the community. We're going to some of the community health organizations, and we're going to be hiring bilingual people in the clinic, including a concierge who will talk to folks, and what are your barriers, and how can we address them to get you here to be taken care of and to join in our trial?

Jeremy Holden:
Thinking about how science works, I know one of the keywords is reproducibility, and it makes me think of the idea that everyone everywhere should have access to the care that they need. So is what you are doing in and around Philadelphia, is the goal to create something that can be shared in other communities and replicated over in Pittsburgh, over in Cleveland, and kind of spreading out to communities around the country and around the world?

Terry Heiman-Patterson:
We're actually going to be, as a parallel study we are actually doing some things that will be more generalizable and studying, looking at the concierge approach to getting folks to clinic and comparing non-concierge to concierge. And we're designing a study that we're actually going to be applying for a grant to do that's going to examine if I meet someone in a health fair or in a physician office and I determine that they're at risk for having let's say ALS, there are two ways I can handle it. I can say, "Look, you really ought to go to a neurologist," and leave it at that.
Or I can say, "You really ought to go to a neurologist. Would you like for us to make some arrangements for you?" And if the person says, "Yes," we then are going to look at two different ways to handle it. One is to say, "Here's a number to call, and the person on the other end will be able to give you an appointment." The second way is to say, "May I have your name, and best way to contact you, and best time to call? We'll call you and work with you to get you an appointment." We then have somebody who's the concierge who would either be in the case of case number one, waiting for a call and would track how many of those folks call.
The second case they would chase down the participant and do everything we can to get them into clinic or into a trial. You can then compare the percentage of people that end up showing the clinic in the one case versus the other case. And in that way look at whether this sort of attention to the barriers, if you will, makes a difference and is there a way to attend to the barriers? And in addition, during that I've created some screening tools that I'm going to be testing to validate for ALS and basically a series of questions.
So as a parallel study it'll be, can we look at the questions and see which ones waited the most or were most important to determining somebody who ultimately ends up having ALS. So that's a separate project, but that screening tool would be something like a mini mental status is used in the primary's office would be a mini neurodegenerative disease or ALS tool to learn who you might want to refer. Because right now primaries all do the mini mental status. Right? That's cognitive test. So why can't they be doing, when somebody comes in with a weakness, use some sort of tool to determine who should go further and go to a neurologist or to a center?

Jeremy Holden:
Fascinating and truly important work. Dr. Heiman-Patterson, appreciate your time with us this week.

Terry Heiman-Patterson:
Oh, thank you.

Jeremy Holden:
I want to thank my guest this week, Dr. Terry Heiman-Patterson. Now, for more information on health care disparities and diversity in the ALS community, check out our conversation with Dr. Michael Cartwright, co-author of a study on racial differences in ALS interventions, or our conversation with Maceo Carter, both of which you can find at connectingals.org. If you like this episode, share it with a friend.
And while you're at it, please rate and review Connecting ALS wherever you listen to podcasts. It's a great way for us to connect with more listeners. Our production partner for this series is CitizenRacecar, post-production by Alex Brouwer, production management by Gabriela Montequin, supervised by David Hoffman. That's going to do it for this week. Thanks for tuning in. We'll connect with you again soon.