Expanding access to clinical trials is crucial to making ALS livable for everyone, everywhere, until we find a cure. One way to help make that a reality is by making sure people from historically underrepresented communities are able to take part in clinical trials.
The effects of drugs and treatments can vary depending on factors such as age, sex, race, ethnicity, and other demographic characteristics. Without including a diverse population in clinical trials, researchers can't fully understand how a treatment works in different populations which can lead to unintended consequences, including adverse effects or lack of effectiveness in certain groups.
On a recent Connecting ALS podcast episode, we spoke with 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 learn more about her work looking into ways to expand access to clinical trials for historically underserved populations.
The following partial transcript of that conversation has been edited for brevity and clarity.
What are some of the main barriers to expanding access to clinical trials?
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, 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 different populations 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.
You mentioned the term “intrinsic bias.” So we're talking about biases that are baked into the cake. They're part of the system as it exists, and we may not be aware of them.
And part of us. These are intrinsic biases we all carry and don't even recognize it. 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.
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, thinking specifically of clinical trials, how does it benefit clinical trials to be more expansive?
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. 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 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.
How is the ALS Center of Hope going to go about tactically reaching out to historically underserved populations?
Luckily, we sit in an area of traditionally underserved populations: Latino, Black, Asian communities, and now immigrants and displaced citizens from other countries that settled here as 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. 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, 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. 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™ tool, but that actually has to get out to those community physicians so 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 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 all compositions by Latin composers celebrating the Latin heritage. And at the same time we'll be talking about ALS and neurodegenerative disease, and we're going to be giving out materials that are in both Spanish and English.
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. 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 find out “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?”
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