FDA urges creation of racial, ethnic recruitment plans for clinical trials

The FDA is encouraging drugmakers to create and submit racial and ethnic recruitment plans for clinical trials early in the drug developmant process in an effort to boost participation among underrepresented populations.

Sponsors of medical products are now advised to develop and submit a “Race and Ethnicity Diversity Plan,” which spells out diverse participant enrollment and retention processes, to the FDA early in clinical development, according to a framework outlined in the new guidance.