Recently, the United States Food and Drug Administration (FDA) released a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.”
Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to improve the data the agency receives about patients who may potentially use the medical product. The draft guidance aims to help medical product sponsors in submitting their Diversity Action Plans to support certain clinical studies.
The draft guidance outlines the format and content of Diversity Action Plans, the medical products and clinical studies for which a Diversity Action Plan is required, and the timing and process for submitting Diversity Action Plans to the FDA. It also details the criteria and process the agency will use to evaluate a sponsor’s request for a waiver to not to submit a mandated Diversity Action Plan.
Diversity Action Plans must be submitted for certain clinical studies regarding drugs, biological products, and devices subject to sections 505, 515, 510(k), 513(f)(2), or 520(g) of the FD&C Act (21 U.S.C. 355; 360e; 360 (k); 360c(f)(2) and 360j(g)), or section 351(a) of the Public Health Service Act 19 (42 U.S.C. 262(a)).
According to the guidance, 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. Sponsors and investigators are encouraged to consider additional dimensions of clinical trial diversity, to enroll populations that represent the patients who will use the product, if approved. Such additional dimensions may include geographic location, gender identity, sexual orientation, socioeconomic status, physical and mental disabilities, pregnancy status, and lactation status.
While the requirements and recommendations described in the guidance are largely aligned across drugs and devices, the types of submissions – and timing of the submissions – in which Diversity Action Plans must be provided differ between drugs and devices under the FD&C Act.
The FDA notes that while most guidance documents do not establish legally enforceable responsibilities, Section VII of the draft guidance that specifies the form and manner for submission of a Diversity Action Plan will have a binding effect and will use words such as must, shall, and required.
The FDA is seeking comments in response to the draft guidance, with a due date of September 26, 2024.
FDA Statements
“Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, M.D. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”
“Generating data for a broader and more representative population early in the clinical development program is among the FDA’s priorities to bring innovative medical products to the public. With FDORA, there is now a requirement for sponsors to submit diversity action plans. These plans may help ensure that sponsors are thinking critically and intentionally about the many characteristics of the patient population they aim to treat when designing their clinical study,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.”