What’s Missing from the FDA Clinical Trials Diversity Action Plan Mandate
Dr. Melissa Davis, Director of the MSM Institute of Translational Genomic Medicine, talks about the recent FDA mandate aimed at increasing diversity in clinical trials.
Dr. Melissa Davis
Director, MSM Institute of Translational Genomic Medicine
By Taylyn Harmon, BlackDoctor.org
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, BlackDoctor.org’s clinical trials editor Ricki Fairley, CEO of TOUCH BBCA and Dr. Melissa Davis, Director of the Morehouse School of Medicine Institute of Translational Genomic 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 underrepresented 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, “Black women have a 41 percent higher mortality rate than white women, and we have a 39 percent higher recurrence rate than white women.” She attributed much of this disparity to the fact that “the drugs aren’t working for us because our bodies were never included in the clinical trials for the drugs that we currently have as [the] standard of care.”
Dr. Davis emphasized the importance of including diverse populations in early phases of clinical trials, particularly in Phase 1, which determines toxicity, safety, and dosage. She explained, “We see a higher incidence of adverse events. So that means the dosage and the safety isn’t the same across the board.”
Both experts stressed the need for a more comprehensive approach to addressing cancer inequities. Dr. Davis described her work with Team SAMBAI (Social, Ancestry and Molecular and Biological Analysis of Inequities), an international initiative spanning three continents that aims to create a comprehensive data resource examining multiple factors contributing to cancer disparities.
“We focus on the multifaceted issues that drive global cancer inequities,” Dr. Davis explained. The program will collect data on societal determinants, environmental exposures, genomics, and tumor immunology from over 40,000 participants across different countries.
Fairley highlighted the importance of patient advocacy and education. “I always challenge doctors,” she said. “I want the golden rule treatment. I want you to treat me like you would treat somebody that you love or somebody in your family.”
She encouraged patients to ask questions such as, “How many Black patients did well with this treatment plan?” and to seek out trusted resources for information.
Both experts emphasized the need for collaboration between researchers, healthcare providers, pharmaceutical companies, and patients to drive meaningful change. Dr. Davis stated, “For the first time, we see this convergence of all of these different disciplines working together at a scale that we’ve never done before.”
Fairley added, “Everybody in the ecosystem has some responsibility for these devastating mortality numbers. And everybody’s gotta take whatever piece of this work they can do to change it.”
The discussion underscored the critical need for earlier inclusion of diverse populations in clinical trials, more comprehensive research approaches, and improved patient education and advocacy to address racial disparities in breast cancer treatment. As Dr. Davis concluded, “Our goal is to provide the evidence that is needed to inform policy changes such as the FDA guidelines and to foster global partnerships.”