Lexology April 15, 2022
On April 14, the U.S. Food and Drug Administration (FDA) released a new draft guidance to industry for increasing racial and ethnic diversity in clinical trials. The draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” recommends that sponsors develop and submit a Race and Ethnicity Diversity Plan (referred to as the “Plan”) to FDA before beginning clinical trials, based on a framework outlined in the guidance, noting that consideration of demographic factors like race and ethnicity are critical to the generalizability of study results.
FDA recommends the submission of a Plan for all medical products for which an IND submission is required or for which clinical studies are intended to...