Reaching Black Americans: 5 Strategies for Companies to Embrace FDA’s Diversity Guidance

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. Asking patients about their experiences 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.” Involving patient navigators and community leaders 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...