Q&A WITH DR. EDDILISA MARTIN: WHY REPRESENTATION MATTERS IN CLINICAL TRIALS
After researchers examined demographic characteristics of 230 US-based clinical trials from July 2011 through June 2020, they found startling results. Among the 219,555 clinical trial participants, White individuals were overrepresented 78 percent of the time, Hispanic participants were represented just 12 percent of the time, and Black individuals were represented only 10 percent of the time, according to February 2021 research published in The Journal of the American Medical Association (JAMA).
With the US Census Bureau predicting nonwhites will represent more than 50 percent of the population by 2045, there is an increased need to create more diversity in clinical trials.
But there’s a problem. Many research networks lack diversity and it’s threatening to potentially derail future treatments for millions of patients. Specifically, drug outcomes may not be applicable to certain populations, unmet medical needs limit our understanding of differences among minorities, and can result in inappropriate recommendations, according to research from RARE-X, a patient advocacy and medical research nonprofit.
Dr. Eddilisa Martin, co-founder and CEO of 2M Clinical, said she believes drug sponsors really do want a diverse population for their clinical trials, but often they don’t have the time to reach those diversity goals.
“Time is money,” Dr. Martin said. “So, the longer it takes to enroll people in your study or the more resources you have to put into training investigators, it costs them more money. If they can get the study done in a shorter timeframe, then that shortens their runway to approval.”
Enter NeighborhoodTrials.com, an innovative solution Dr. Martin spearheads to bring new therapies directly to patients. More specifically, NeighborhoodTrials.com is a customized, interactive, A.I. data-driven, web-based platform that uses technology to connect patients, community-based organizations, sponsors, and investigators to clinical trial opportunities with a focus toward underrepresented populations.
In a recent interview, Dr. Martin discussed the importance of leveraging their collective expertise to bring new therapies to patients more effectively.
What can we expect out of NeighborhoodTrials.com next year in 2022?
Yes, 2021 was kind of the formation year for NeighborhoodTrials.com. We’ve really been fine-tuning the technology and troubleshooting how things work. In 2022, we hope to see a lot of growth in the platform. What I see from NeighborhoodTrials.com is a two-pronged service where it will serve as a database for collecting information on people who are interested in participating in clinical trials. They may not want to participate in a clinical trial right away, so based on the questions that they answer and the interest they’ve shown, we would use the database to notify them when there’s a clinical trial for their particular disease state or if they just want to be a healthy volunteer.
And then the other approach for NeighborhoodTrials.com would be more of an active recruiting function. Whenever we’re engaged to support enrollment for a particular clinical trial, we would use our technology to help find appropriate patients for those clinical trials. They may be patients who are already in our database organized by certain characteristics or demographics. We also will be using our innovative technology to proactively find those patients and get that clinical trial information directly to them.
We see it as a potential database for physicians and investigators who are looking for clinical trials in which to enroll their patients; it could be a platform where they can readily research information, especially if they are a physician who is not an investigator but are still interested in participating in clinical trials.
Through NeighborhoodTrials.com we can make them more equipped to be an investigator for clinical trials as well. We know that the more diverse your investigator pool is, or the people who are conducting the research, then the more likely you are to have a more diverse patient population.
How did we get to the point where we need a resource like NeighborhoodTrials.com? Why isn’t the industry set up to automatically have diversity in place?
Well, it takes a lot of work. Many times, when sponsors are enrolling clinical trials, they really do want a diverse population, but time is money. So, the longer it takes to enroll people for your study or the more resources you have to put into training investigators, it costs them more money. If they can get the study done in a shorter timeframe, then that shortens their runway to approval. It shortens the resources they have to put into research.
So, we believe we can proactively collect this database of patients or willing participants. We believe we can help them understand why it’s important that they are part of the clinical trial process. We can explain to them that when drugs, or therapies, or different treatments are approved, they’ll be approved for patients that look like them. They can know that this clinical trial is designed to potentially help their family members and friends who may need treatment. They can feel confident that, yes, it was studied in somebody that looks like you, so you can be more confident in the therapy. If we can do this proactively, to where it shortens the runway for enrolling diverse patients, we can make that recruitment process more efficient and a little less painful for the sponsors. With regard to increasing diversity in their trials, I think a lot of people have good intentions, but when the rubber meets the road, you want to get your study complete. And so, sometimes that means just enrolling on a first-come, first-serve basis, or the easiest way to get patients. Sometimes it gets to that point.
How did the idea for NeighborhoodTrials.com originate?
We’ve known for several years that it’s something that we wanted to do, to be able to have this group or to have this kind of pool of diverse patients, because we knew that there is not adequate representation in clinical trials. Of course, as we have all seen, COVID really highlighted the disparity in health care and access and also the disparity in the clinical trial world.
So, I was really glad that the vaccine sponsors made an effort to try to increase diversity in their clinical trials. But it really highlighted what many of us have known for years: that things are not equal regarding clinical trials. We know, again from our diverse perspective, that people are more willing to trust people who look like them. And I don’t think that there are many people who look like us who were in this space of patient recruitment.
Having more diverse people who were in the clinical space of patient recruitment may be able to draw out some people who might not have been as willing to participate if they were approached by someone else. We have the clinical knowledge; we have the expertise; and we’re qualified. But then to approach people who look like us or when people see us out there, I think it helps.
Do you also have a personal connection to clinical trials?
We have a family member, in particular, who was enrolled in a clinical trial. And by enrolling in that clinical trial, we were able to actually see that her health care improved versus what she was getting in her hometown. And I don’t think most people understand how clinical trials can support your health care options. I think that it takes people like us to help educate others. Just because you’re in a clinical trial doesn’t mean you’re being a guinea pig. It doesn’t mean that you’re being taken advantage of. And if you don’t want to continue, you don’t have to. We want to educate on all the things that have happened to protect patients in the clinical trials space, versus the nightmare type of scenarios that people continue to talk about from the Tuskegee experiment, et cetera. There are so many things that have been put in place to protect patients who participate in clinical trials so that things like that don’t happen again.