Three Experts on What the FDA’s Diversity Action Plan Mandate Means for You

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance aimed at increasing diversity and representation of underrepresented racial and ethnic populations in clinical trials. This move is a significant step toward ensuring that the treatments and therapies approved by the FDA are effective and safe for all segments of the population, including Black Americans. BDO executive editor Jade Curtis hosted a conversation with esteemed individuals, in partnership with the NIH’s Cancer Moonshot, on what this draft guidance means for Black Americans and future drug approvals. The Need for Diversity in Clinical Trials Historically, clinical trials have often failed to adequately represent the diversity of the U.S. population, leading to potential disparities in the efficacy and safety of approved treatments for certain groups. By mandating that clinical trial sponsors submit demographic data on trial participants, the FDA hopes to address this issue and promote greater inclusivity in medical research. “The reason that this is so important is because as a doctor, if [a patient] comes into my office and they’re Black, for example, and [a clinical] trial was done only in white people, then it’s gonna be hard for me to say with a 100 percent certainty,...