Experts on the FDA’s Diversity Guidance for Clinical Trials: “We Need to Focus on What Works”

The FDA’s recently released draft guidance on diversity action plans for clinical trials has brought renewed focus on increasing the representation of underrepresented populations in clinical trials. The plan aims to address long-standing disparities in health outcomes and ensure that new treatments are tested adequately within diverse communities. BDO hosted a virtual town hall discussing what the new FDA guidance means for clinical trials and getting Black Americans the medicine they need. What exactly is in this FDA draft guidance? Jeanne Regnante, CEO and founder of Patient 3i, as well as a patient advocate for the Tigerlily Foundation, explains the main objectives of the plan: “The action plan is a very important element that the FDA has just introduced in follow-up to the FDORA Act of 2022. This is sort of the second foot, the implementation,” Regnante tells BDO’s executive editor Jade Curtis. “And it focuses upon enrollment increase and increase in participation of historically underrepresented populations in clinical trials.” One key aspect that sets this plan apart from previous diversity initiatives is its emphasis on community engagement strategies. Elaine Palmer, director of clinical operations at Pivotal Clinical Research, notes, “Community engagement strategies are much more pronounced in the new...