Pharmaceutical Executive April 20, 2022
Dual efforts focused on more inclusive research and more diverse enrollment in pre- and post-approval studies.
FDA recently issued a new guidance on how to make clinical research more inclusive, building on earlier, broader advisories on the topic. At the same time, Congress is looking to advance legislation promoting clinical trial diversity in pre- and post-market studies, while the latest revision to drug user fee programs includes provisions for advancing clinical trial diversity in sponsors’ R&D programs. These initiatives fit the Biden administration’s broader goal of addressing racial and ethnic health care disparities through a range of public research and coverage programs.
This latest FDA draft guidance follows its advisory on “Enhancing the Diversity of Clinical Trial Populations” published in...
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