FDA Offers Guidance to Enhance Diversity in Clinical Trials

The FDA released a statement (9 November 2020) outlining its commitment to promoting greater diversity in medical product development and issuing a new guidance document outlining the agency’s thinking on encouraging greater inclusivity.

“Enhancing the Diversity of Clinical Trial Populations–Eligibility Criteria, Enrollment Practices, and Trial Designs.”

The guidance provides recommendations for sponsors on how to increase enrollment of underrepresented populations, guidance on broadening clinical trial eligibility criteria for clinical trials of investigational drugs intended to treat rare diseases and other considerations about the inclusion of important groups including racial and ethnic minorities, women and older people.

Read the full statement here.