New Details on Diversity Action Plans Provided by the US FDA

On June 26, 2024, the US FDA released a draft guidance titled, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.

The goal of the draft guidance is “to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies.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 within clinical studies not only facilitates broader applicability of results across a broad spectrum of patient populations, but also enhances understanding of the disease or medical product under study, thus providing valuable insights to inform the safe and effective use of the medical product among patients.”