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The U.S. FDA continues to intensify its focus on improving diversity in clinical trials. On June 26, 2024, the long-awaited draft guidance was published: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This draft guidance is now open for comments through September 26, 2024. Until the final version is published, it replaces the FDA’s previous guidance published in April 2022.
"Since July 2023, we have been helping sponsors prepare their Diversity Action Plans and have worked on 37 plans so far. We have been actively gathering the FDA's feedback to better prepare for studies that will start once approval of a Diversity Action Plan before initiation of pivotal studies is mandated," said Beatriz Rocha, MD, PhD, Chief Regulatory Liaison Officer at Fortrea. "The new guidance describes the format and content of Diversity Action Plans, including the timing and process for submitting such plans. In addition, the guidance describes the criteria and process by which the FDA will evaluate sponsors' requests for waivers, and those who may wish to publicly post key information regarding their Diversity Action Plans."
The Fortrea Regulatory Strategy Consulting team continues to closely track the U.S. regulatory landscape to understand how other regulatory agencies (such as the European Medicines Agency [EMA] and Medicines & Healthcare products Regulatory Agency [MHRA]) are working to meaningfully improve the diversity of clinical trial participants in global studies. Together, we can help you meet legal requirements and ensure that therapies are developed in a population with demographic characteristics of the intended use population in the real world.
