USA – FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance aimed at increasing diversity in clinical trial populations as part of its efforts to encourage drugmakers to enroll populations that more closely reflect the populations that will take the drugs in the real world.

“This guidance recommends approaches that sponsors of clinical trials to support a new drug application [NDA] or a biologics license application [BLA] can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their clinical trials,” FDA writes.

The guidance, which was required under section 610 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA), builds on past efforts by FDA and Congress to broaden clinical trial eligibility criteria to historically underserved populations, including women, the elderly and minorities…