The FDA today issued a new draft guidance outlining plans for increased diversity in clinical trials in the U.S.
Expanding upon previous guidances for improving clinical trial diversity, this latest draft guidance — “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials” — recommends that sponsors of medical products develop and submit a “Race and Ethnicity Diversity Plan” to the agency in the early stages of clinical development, based on a framework outlined in the guidance.
