What’s Missing from the FDA Clinical Trials Diversity Action Plan Mandate

The recent FDA mandate aimed at increasing diversity in clinical trials fails to address critical issues in breast cancer treatment for Black women, according to experts. In a discussion hosted by Taylyn Washington-Harmon, BDO’s clinical trials editor, Ricki Fairley, CEO of TOUCH BBCA, and Dr. Melissa Davis, a distinguished investigator at Morehouse School of Medicine, highlighted the shortcomings of the FDA’s approach and emphasized the need for earlier inclusion of diverse populations in drug development. The FDA’s diversity action plan mandate requires pharmaceutical companies to provide a plan for reaching patients who need new drugs when submitting for approval. However, this requirement only applies to Phase 3 clinical trials, which both Fairley and Dr. Davis argue is too late in the process. “By phase 3, we’re in the birth canal for that drug. It’s cooked. It’s done,” Fairley explained. “They’re not gonna do any major changes to the [drug] formulation at that point.” Dr. Davis echoed this sentiment, stating, “We have to somehow make sure that we stress the importance of including these under-represented populations across the spectrum. It should be a requirement at every phase.” The experts highlighted stark disparities in breast cancer outcomes for Black women. Fairley noted,...