Derek van Amerongen, MD, MS: Another use of data, of course, is to educate us in terms of the scientific processes we need to [use]. That all comes from clinical trials, and yet we know that the under-representation of persons of color in studies has been a long-term, chronic issue. Dr Hawkins, what challenges do you see in the clinical trial enrollment of minority individuals? In order to strengthen that data and give us information that’s going to be as actionable as possible?

Soyini Hawkins, MD, MPH, FACOG: Unfortunately, there are a lot of challenges in that aspect, and we definitely need to be collecting the data, especially in areas of disparity in the different patient populations, specifically, [the] women patient populations that we’re taking care of. Some of the historic areas that we’ve had [limiting] boundaries on is trust, the trust that some of our patients have just for the institution of medicine, but even more specifically, in research. Because we do have historic data or historic events where we’ve had unethical practices in the way that we’ve treated subjects in research. And that’s a hard, actionable event that is hard for us to turn around for a lot of the populations that we want to enroll in our research studies. Some of the areas that we also need to look into are socioeconomic barriers. Do they have transportation, something as simple as that, to get to the study site? [Can] they get childcare, or can they simply take time off from work? And what about the question of, do they even know of the studies, or have access to them? Do they know of the studies that might be specific to their disease process or that they would be great subjects for, or great participants? If they’re not getting even access to the health care providers that might be enrolling or participating, they won’t…have knowledge of those things. And then when we talk about patients who are in minority populations, black, Hispanic, Asian, women, they have specific cultural barriers as well, language. We have to be able to, 100% have transparency and clarity in the way that we’re conducting our studies, but also, they have to give informed consent. And they have to be able to do so comfortably. That’s part of the trust that we have to rebuild in these populations to be able to collect the data that we need, so there are no disparities in the way that it’s analyzed, and then it’s more generalizable to our population of women we’re taking care of.

Derek van Amerongen, MD, MS: And you use the word trust, which, of course, is fundamental to giving people the confidence to participate, but also, you raise a really interesting point about the role of the investigators. And Dr Wells, I’m sure both you and Dr Hawkins have dealt with this, in terms of how you get not just the patients, the potential subjects, but the investigators, the clinicians to reach out and enroll members, to take that time and effort to do that? What are the challenges there?

Soyini Hawkins, MD, MPH, FACOG: There are challenges for the institution as well [such as if] they feel like the patient population may be outside their current reach in their own clinical settings. I’m in private practice, so even though I’ve been an investigator on numerous studies, [sometimes] I cannot reach them through marketing that might be directed specifically to the patient population that we want to enroll. If we’re doing a study on fibroids, for example, there’s a greater disparity in [patients with fibroids who] are Black. But we should also be enrolling Hispanic and Asian and Caucasian women into our studies. So if that’s outside the scope of my population, how are we marketing to all the different ethnicities to make sure they’re a [part] of it? From the institutional standpoint, maybe I’m speaking from a small institution standpoint and [from a] private practice [standpoint], but that is one of the barriers I feel like I have on my side of the story, to get actual populations enrolled that we want to see flourish in our studies and be accounted for.

Derek van Amerongen, MD, MS: And Dr Wells, what would be your perspective there?

Roxie Cannon Wells, MD: My perspective is, how do we reach people where they are? I think to Dr Hawkins’ point, it’s important to actually be in the communities. I’m always amazed that, if I go into an underserved community or if I drive through an underserved community, I always see a plasma donor center. But I never, ever, ever see, or I should say, rarely would I see, clinical trial sites in those communities. So, I think it’s extremely important that we take clinical trials to the community. Again, talking about transportation. How are people supposed to get to major centers when they can’t get across town to their primary care provider? So [talking about] clinical trials, and our health system, we are doing clinical trials, and it really is about taking clinical trials to the communities. Also, again, I think you made the point of trust. Making sure that individuals look like the individuals who are participating, or who they want to participate in clinical trials. I think that that’s extremely important. And then, engage the community in conversation. And it really starts before you start clinical trials. It really starts with forming a relationship with underserved communities so that there’s trust and that there’s education and understanding about clinical trials. And then last but not least, really thinking about how we [in] health systems can think ahead and really look at patients who would fit certain clinical trials, and actually looking for those patients in underserved communities. There’s quite a bit of work to do, and as I stated before and I’ll state again, it’s rare that I go through an underserved community and I don’t see a plasma donor center, but it’s extremely rare if I were to see a clinical trial site.

Sharon Deans, MD, MPH, MBA: I think from the payer’s perspective, the additional comments that I have around clinical trials are the awareness of the conductors of the trial [of] the need to include minority patients, and understanding what the offerings are. Particularly for Medicaid, we provide transportation; 1 in 5 people don’t have transportation to their regular doctors, to get their prescriptions, or to go to the grocery store. While we don’t cover clinical trials and experimental therapy, we provide all the supportive care in many of our states, if not most, for those clinical trials so that folks can participate. But I think increasing awareness of the folks conducting the trials that minorities need to be included. And it’s extra work because they need more handholding, more explanation, and multiple [explanations of] the same thing, and then working with the insurance company to coordinate their care and get them to the services.

Soyini Hawkins, MD, MPH, FACOG: They need more resources.

Sharon Deans, MD, MPH, MBA: They need more resources, exactly.

Roxie Cannon Wells, MD: I agree, and I would add too that there’s the component of mistrust. We all know the history of the Tuskegee trial, and that has lingered. So, [it’s] mistrust, and dealing with the mistrust those communities have. It isn’t always that communities of color don’t understand clinical trials and what they mean and the importance of them. There is the issue of mistrust that has been a historical thing in our communities.

Sharon Deans, MD, MPH, MBA: I think [it’s important to be] creative, though, when you go out into the community; for instance, in the African American community, the church is a big source of trust and credibility. So in my plans, I say, when are we going to church? When are we going to tell people the information they need to know, [how are we going to] get the buy-in from the pastor and the leaders of the church? And then present at the end of a service. I think being able to think outside the box in the approach to minority patients is extremely important as well.

Roxie Cannon Wells, MD: I would add to that [what] we saw that recently during the pandemic, where we needed people in the clinical trials, and we needed people to actually begin to take the vaccines, and it was pastors, barbershops, physicians’ offices that they trusted [who were] the people we were able to move people toward…participating in the clinical trials, and then, actually getting the vaccine.

Derek van Amerongen, MD, MS: And, clearly, multiple stakeholders are involved.

Soyini Hawkins MD, MPH, FACOG: I would add only one more point. I think that we can also do better in transparency. And give our patients and the populations that we’re treating the benefit of the doubt, that they can understand what the clinical trials are actually for, and they can understand the nuances of what we are asking of them. That transparency will make them buy into it. Buy into the trials and buy into the information, because at the end of the day, we’re trying to bridge the disparity gap and make all of these things that we’re researching, the technology that we’re building, more applicable to these populations of women.

Derek van Amerongen, MD, MS: Again, [that goes] back to your comment earlier about trust.

Soyini Hawkins, MD, MPH, FACOG: Absolutely.

Transcript edited for clarity.