FDA issues final rule on clinical trials diversity
The U.S. Food and Drug Administration has finalized a rule requiring drug sponsors to submit diversity action plans for clinical trials. This aims to ensure better representation of underrepresented groups in medical research. The rule takes effect in 2025.
On October 10, 2024, the FDA announced the finalization of its rule on enhancing diversity in clinical trials, a significant step in addressing longstanding inequities in medical research. The rule mandates that sponsors of certain drug and biological product applications submit diversity action plans to the agency, outlining strategies to enroll participants from demographic subgroups, including racial, ethnic, and other underrepresented populations.
According to the FDA, 'Diversity in clinical trials is essential to ensure that safe and effective drugs reach all Americans who need them,' stated FDA Commissioner Robert M. Califf, M.D. This builds on a proposed rule from 2022, incorporating public feedback to refine requirements without adding undue burdens on sponsors.
The background stems from the 2020 COVID-19 pandemic, which highlighted disparities in health outcomes and trial participation. Data from the FDA shows that historically, clinical trials have underrepresented groups such as Black, Hispanic, and Indigenous populations, leading to gaps in drug safety and efficacy knowledge for these communities. The new rule applies to Phase 3 trials and certain earlier phases for drugs addressing serious conditions, with submission deadlines starting January 2025.
Industry groups have mixed reactions. The Pharmaceutical Research and Manufacturers of America (PhRMA) welcomed the clarity, noting, 'We support efforts to improve trial diversity, but implementation must be practical,' per a spokesperson. Patient advocacy organizations, like the National Minority Health Association, praised the move, saying it 'finally prioritizes equitable research.'
Implications include potential increases in trial costs and timelines, but experts anticipate long-term benefits in personalized medicine. The FDA estimates minimal economic impact, around $1.7 million annually across the industry. This rule aligns with broader Biden administration initiatives on health equity, though challenges remain in recruitment and data collection.
No contradictions were noted in the source, which focuses solely on this FDA action.