Draft Guidance Issued on Diversity Action Plans

The FDA has issued a draft guidance aimed at increasing diversity in clinical trials. The document describes the format and content of Diversity Action Plans, the situations in which a plan is required, and the timing and process for submitting a plan to the FDA. It also pushes study researchers and sponsors “to consider many dimensions of clinical trial diversity, even those that extend beyond age, ethnicity, sex, and race, to enroll populations that represent the patients who will be treated if the product is approved”—for example, pregnant or lactating women. This draft guidance replaces one issued on April 14, 2022; comments on the new document may be submitted until September 26 at https://www.regulations.gov.