As the FDA doubles down on its efforts to increase diversity in clinical trials via the FDORA Act, companies are grappling with how to engage and recruit Black American participants effectively. Overcoming historical distrust and addressing systemic barriers is crucial to achieving meaningful representation in medical research. BDO hosted a virtual town hall with top clinical trial experts discussing what the new FDA guidance means for clinical trials and getting Black Americans the medicine they need.
According to Jeanne Regnante, CEO of Patient 3i LLC, the key lies in shifting the focus from perceived barriers to what works. “We need to focus on what works,” she states. “We need to ask the patient for their experience before, during, and after clinical trials. For example, if the participant partners that we work to engage in a clinical trial where they feel they’re not respected or they feel that bias has been placed on them, then the sponsor shouldn’t use that site.”
Building trust and respect through authentic community engagement emerges as a recurring theme. Regnante further emphasizes the importance of involving patient organizations, navigators, and community leaders in the planning and execution of diversity action plans. “A strong, diversity action plan, I think, would be reviewed and edited by patient organizations, navigators, and community leaders. It needs to be owned by them. It’s for them by them.”
Elaine Palmer, director of clinical operations at Pivotal Clinical Research, highlights the need for companies to establish long-term relationships with communities before seeking participation in clinical trials. “So in the African-American community where there’s already, you know, some communities where there’s already so much distress, let’s, you know, I encourage the [pharma companies] and the CROs come in, garner that relationship, get to know, get to know the people in the community and then come with your ask.”
Ensuring that clinical trial sites are accessible and familiar to Black Americans is another crucial aspect. As Regnante notes, “We need to put new sites in the community where people live. And decentralized clinical trials are never gonna get us all the way there.”
Dr. Randall Morgan, Jr., executive director at the Cobb Institute echoes this sentiment, emphasizing the importance of meeting people where they are: “It’s not gonna work otherwise.”
Beyond community engagement, companies must also address practical barriers that may hinder participation. The FDA guidance recommends measures such as providing transportation assistance, flexible scheduling, and compensation for time and expenses.
As Palmer explains, “Making sure [patients] have a travel allowance. Research patients should never have to come out of their pocket to pay, to participate in clinical research.”
Transparency and open communication are also essential in building trust with Black communities. Sharing trial results and ensuring participants understand their rights and the potential benefits of their involvement can go a long way in fostering a positive experience.
“So I think we need to do a better job when possible to share those results with the participants, especially if they were participating in the study that they were taking a placebo or a dummy drug versus the study drug. Share that information with them so that they can understand and feel that closure,” suggests Palmer.
Ultimately, as Regnante eloquently states, “It’s not health equity until the patient says so.” Companies must be prepared to listen to the voices and experiences of Black participants and adjust their approaches accordingly.
By prioritizing authentic community engagement, addressing practical barriers, fostering transparency, and centering the voices of Black Americans, companies can take meaningful strides towards embracing the FDA’s guidance and advancing health equity in medical research.
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