The U.S. Food and Drug Administration (FDA) issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in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.
This draft guidance describes the format and content of Diversity Action Plans, the medical products and clinical studies for which a Diversity Action Plan is required, as well as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 The draft guidance also outlines the criteria and process the agency will use to evaluate a sponsor’s request not to submit a required Diversity Action Plan, also known as a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.
Diversity Action Plans must specify the sponsor’s rationale and goals for clinical study enrollment (separated by the age group, ethnicity, sex and race of clinically relevant study populations) and describe how the sponsor intends to meet those goals. The guidance also urges sponsors and investigators to consider the 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.
The requirement for sponsors to submit Diversity Action Plans comes from new provisions of the Federal Food, Drug and Cosmetic Act added by the Food and Drug Omnibus Reform Act (FDORA). These plans apply to phase 3 clinical studies or, as appropriate, other pivotal clinical studies of a drug or biological product, as well as for certain clinical studies of devices, including those intended to serve as the primary basis for the FDA’s evaluation of the safety and effectiveness and benefit-risk determination of the device. The requirement to submit a Diversity Action Plan applies to clinical studies for which enrollment begins 180 days after publication of the final guidance.
Comments on the draft guidance should be submitted within 90 days after publication in the Federal Register to Regulations.gov. All written comments should be identified with the docket number and with the title of the guidance document.
