FDA releases final guidance on clinical trial diversity

The FDA is requiring the teams who run clinical trials for new treatments and medical products to ensure greater enrollment for underrepresented groups so that the resulting products do not exacerbate existing health disparities, the agency said in final guidance issued Nov. 9.

The 21-page document includes recommendations on how clinical trial teams can widen eligibility and enrollment for groups historically underrepresented in trials, such the Black and Latinx community, pregnant women and those with certain physical conditions. The agency's guidance also says clinical trials should be designed to take into account the different ways bodies can metabolize drugs and how that differs in patients with certain conditions.

The FDA also recommended clinical trials teams try their best to not to require frequent visits to trial sites from participants, as this inconvenience may reduce diversity within participants. The agency encouraged clinical trials teams to offer virtual check-ins via electronic communication.

"We have seen these health care disparities, for example, during our fight against COVID-19, as certain segments of the population (e.g., older adults, pregnant women, children, and racial and ethnic minorities) are affected in different ways," FDA Commissioner Stephen Hahn MD said in a statement. "This difference in impact illustrates why we must encourage developers of any medical product such as treatments or vaccines for COVID-19 – as well as medical products more broadly — to endeavor to include diverse populations to understand their risks or benefits across all groups."

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