FDA Issues Guidance for Diversity Action Plans to Support Clinical Studies

The FDA issued a draft guidance aiming to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies.

Diversity Action Plans are “intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product.” Enhancing diversity helps to provide valuable insights about both the disease or medical product under study and results across a broad spectrum of patient populations.

This draft guidance, entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” sets out to describe “the format and content of Diversity Action Plans, the medical products and clinical studies for which a Diversity Action Plan is required, as well as the timing and process for submitting Diversity Action Plans to the FDA. The draft guidance also outlines the criteria and process the agency will use to evaluate a sponsor’s request not to submit a required Diversity Action Plan, also known as a waiver.”

The requirement for sponsors to submit Diversity Action Plans applies to phase 3 clinical studies or, “as appropriate, other pivotal clinical studies of a drug or biological product, as well as for certain other clinical studies of devices.”