FDA Details Preferred Approach To Collecting Diversity Data

An expected final guidance document from the US Food and Drug Administration that will require clinical trial sponsors to submit diversity action plans is yet to make an appearance, even though legislation passed in 2022 called for it to be issued by the end of last year. But that doesn’t mean the FDA hasn’t been acting to encourage more diverse study populations.

Most recently, the agency issued a cross-center draft guidance document titled “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.” The guidance...