In medical research, clinical trials are how new treatments, drugs or surgeries get tested. They’re how researchers figure out whether treatments work and whether they’re safe and effective. For the individuals who participate in them, they are also an opportunity to be exposed to new and innovative treatments.
But nationwide, clinical trials have a problem: People of color are often underrepresented. As a result, what researchers learn doesn’t apply to as many people as it should, which can perpetuate poor health outcomes. In December 2022, Congress passed a law that requires drug and medical device makers to submit diversity action plans to the U.S. Food and Drug Administration ahead of clinical trials. (The FDA has since missed its December 2023 deadline to issue guidelines for making these plans.)
Researchers from Advocate Aurora Research Institute, which serves Wisconsin and Illinois, recently surveyed the healthcare system’s own clinical trials. Initially, funding for the project aimed at understanding equity in the system’s COVID-19 clinical trials. But there were just half a dozen of those, while Advocate Aurora runs as many as a hundred trials at any given time.
“We were sort of like, ‘OK, if we want to look at the equity in our COVID clinical trials, why don’t we look at the equity in all of our clinical trials?’” said Dr. Veronica Fitzpatrick, a research scientist who led the study. “We took our funding and tried to answer bigger questions with it.”
The researchers also sat down with community members who self-identified as Black, Hispanic and Asian to hear how they think diversity in these trials can be improved. They recently summarized their findings in two papers.
In the past year, Advocate Aurora has started to implement some of the suggestions, from bolstering translation services to partnering with its community health department to integrate more meaningfully into the community. An update to their medical record system also now documents who is asked to participate in a trial — as opposed to who consents to participate — in order to track ways implicit bias might appear in screening participants.
Fitzpatrick and Osondi Ozoani-Lohrer, a senior research associate, spoke with WUWM’s Lina Tran to share what they’ve learned.
This conversation has been edited for length and clarity.
This is going to sound maybe obvious. But why is it important that your clinical trials are representative of the community that you're serving?
Osondi Ozoani-Lohrer: Science and clinical trials, in general, is a fundamental subject where if our trials are not equitable or if it doesn't show enough diversity, those results get perpetuated. And it creates bias. It creates a situation where certain groups of people get access to innovative healthcare. It creates health outcome disparit[ies]. If we have a study, in that sense, that’s lacking diversity, [it] gets perpetuated. Somebody else would pick that study and make it a building block of their study. Solving that problem at its initial stage is very important.
Dr. Veronica Fitzpatrick: Because not everyone is white men.
Ground-breaking observation! Not everyone is white men.
Fitzpatrick: My research is mostly in care delivery and prenatal care. As we're seeing across this country, there's a really, really big issue with Black women, in particular — maternal and their baby outcomes are just embarrassingly poor in this country. That's not anything that has to do with our healthcare system. That’s just across the board. It's so critical to have people enrolled in these studies who are going to be benefactors of the results.
Are there examples of medications or treatments where historically, their effectiveness was shaped by race or gender? And people realized, “Oh, it's because we just weren't assessing how well they work on all the right people.”
Fitzpatrick: Heart disease is a really good example. All clinical trials for heart disease were in white men. And the way heart disease looks in women is very, very, very different than men. The drugs and the treatments weren't as effective in women. So finally, they were like, “Wait a minute, maybe we should include women in clinical trials.”
So you set out to do this inventory. What are the trends that you find?
Ozoani-Lohrer: We found that the people most likely to participate in clinical trials are white women over the age of 65. We also found that people of color are not as well represented in clinical trials. So we set out to create this environment where we could talk to the people in the community that we serve and see what the barriers are, what's preventing them from participating in clinical trials and what solutions that they think we could apply — and make them participate more in clinical trials.
What kinds of things did you hear from them?
Ozoani-Lohrer: When we started to conduct the interviews, trust was one of the things that was just in the back of my mind. But what we found was trust was a byproduct of the need for more knowledge about clinical trials, more of a presence in the community. If the people that we're trying to approach about clinical trials don't understand clinical trials because they haven't been exposed enough, or they don't know us as well, it's difficult for them to participate and trust us enough to participate in clinical trials.
Fitzpatrick: I think there's a lot of mistrust among communities of color when it comes to any sort of experimental medicine, right? Very, very well-founded lack of trust. To Osondi’s point, not all clinical trials look the same. Some are experimental devices and drugs and some are just an app on your phone. So I think there's a misunderstanding that everything is sort of “take this drug that we've never tested” or “try this thing in your heart that we've never done before.” A lot of clinical trials are not that. The lack of knowledge about the depth and breadth and what they entail, and how they are considered legitimate treatments, was one thing that sort of rose to the top.
It was not so much that people wouldn't participate — and not so much that people wouldn't participate, despite not trusting the healthcare system. It was just that they didn't know much about them. They didn't know anything about them until they were sick. They didn't know where to even find clinical trials, they didn't know how to get more information. And that was one of the things where we were like, OK, so what can we do as a healthcare system to better educate the community, so they wouldn't pass up this opportunity to be part of a potentially innovative treatment?
Yeah. How did it feel as someone who's — as a healthcare professional, as a researcher, to hear some of those things?
Ozoani-Lohrer: There is an understanding to it. One participant actually said, when there is a study or clinical trial going on, they see us. They feel that presence in the community, where they're recruiting, where they're talking to them about the study. But then, when that trial or that study is over, we're gone. Because then we retreat back to do our analysis and our writing.
What we've done is we've created a relationship and a connection, and then we just kind of — stop. So I can understand that. It's really important to have a constant connection with the people that we're serving or presenting these clinical trials to. So it's not a case of “oh, we just need you for now, we don't need you anymore.”
What do you think it would look like to shift that relationship?
Ozoani-Lohrer: We got so many solutions from our community members and even our clinical trial staff. One of the things that we got out of it was creating a presence. Creating some kind of connection. First of all, just having a sit-down with them and listening to them.
Fitzpatrick: I've been a health disparities researcher for over a decade. So I'm certainly not surprised when vulnerable populations — that could look like anything. That could be people of color, that could be lower-income people, that could be people who do not speak English as a primary language. Anybody who's really at a disadvantage in our super highly literate healthcare system.
Osondi, I think you said it super well. We take. As researchers, we take from our communities and sometimes forget to give it back. What are the dissemination products of research? It’s manuscripts, it's peer-reviewed papers, it's presentations at medical conferences. That is not where the community is. And those are not things that the community understands. I think it's really on us.
We're lucky because we work in a healthcare system, so we can actually show what the results are. And we can actually make changes in our healthcare system. People's interview time and people's opinions means a lot to them. To just take them and not give it back to the community doesn't close that loop. We're really, really trying to close that loop.
This is really interesting because people talk about this in journalism too. How can we not be extractive and take people's stories and say, “Bye, never see you again!” And how can it be more symbiotic?
Fitzpatrick: You're totally right. It’s the exact same thing. These are who these people are. What they're giving us — the vulnerability that they're allowing us to share in — is something that, you know, ends up being a line in a paper when it’s not. It's their experiences and lives. We have direct interactions with the people that we’re taking this data and experiences from. And so we take it very seriously to try to do something with it. It's not just for funding. It's to take the lessons learned and try to implement them as best as we can.
Going back to the listening sessions, I'm wondering if either of you have a memorable moment. Was there a breakthrough or something that really surprised you?
Fitzpatrick: I was surprised by how many people were willing to participate in clinical trials. It's a lot of interactions with the healthcare system. You have to drive there, you have to sit there, you have to have some sort of treatment schedule. But I don't think there was a single person we talked to who was like, "no way, I would never do that.”
Most people were like, “yeah, OK.” We talked to old people, we talked to young people. Almost everybody identified as a person of color — that was one of our inclusion criteria. I was really surprised by that. Because even myself, I'd be like, “I don’t know, seems like a lot of work.” But really, people were pretty enthusiastic. And again, even though people were like, “I don't totally trust the healthcare system,” they were still willing to participate. That says a lot. There's this misconception that people of color don't want to interact with the healthcare system. That is not true based on the people we interviewed.
Which is like a scientist's dream, right? There's this whole pool of data, but you've just got to bridge the gap. They're willing to share it.
Fitzpatrick: Totally. I think as researchers, as predominantly white people, we make a lot of assumptions about how people feel. It's not until we go into the community and ask these questions directly, where we can really fight those assumptions. A lot of people assume if you don't trust the health care system, then you're not going to participate in a clinical trial. The community was loud and clear. They were like, “We are happy to participate in clinical trials. We literally don't know how to do that.”
Ozoani-Lohrer: And that's that point with implicit bias. Because we already think in our heads, “Oh, you know, they don't want to.” Maybe that's why we don't have them.
