Monday, July 15, 2024

Clinical Studies to Improve Diversity with New FDA Draft Guidance on Enrollment

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Clinical studies are the focus of a new draft guidance released by the U.S. Food and Drug Administration (FDA) titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” This document aims to assist medical product sponsors in creating and submitting Diversity Action Plans to support specific clinical studies. These plans are designed to increase the enrollment of participants from historically underrepresented populations, thereby improving the quality and relevance of data collected about the patients who may potentially use the medical products.

Enhancing diversity in clinical studies is crucial as it ensures broader applicability of results across various patient populations. This diversity provides a more comprehensive understanding of the disease or medical product under study, offering valuable insights that inform the safe and effective use of the medical product among different patient groups.

“Participants in clinical trials should be representative of the patients who will use the medical products,” stated FDA Commissioner Robert M. Califf, M.D. The draft guidance represents a significant step in addressing the participation of underrepresented populations in clinical trials, thereby improving the data available about patients who will use the medical products if approved.

FDA Draft Guidance Requires Diversity Action Plans for Clinical Studies

The draft guidance outlines the format and content required for Diversity Action Plans. It specifies the types of medical products and clinical studies that necessitate a Diversity Action Plan, as well as the timing and process for submitting these plans to the FDA. Additionally, the guidance details the criteria and process the FDA will use to evaluate a sponsor’s request for a waiver from submitting a required Diversity Action Plan.

Diversity Action Plans must clearly articulate the sponsor’s rationale and goals for clinical study enrollment, categorized by age group, ethnicity, sex, and race of clinically relevant study populations. The plans should also describe the strategies the sponsor will use to achieve these enrollment goals. Furthermore, the guidance encourages sponsors and investigators to consider various dimensions of clinical trial diversity beyond age, ethnicity, sex, and race, ensuring that the enrolled populations accurately represent the patients who will be treated if the product is approved.

The requirement for sponsors to submit Diversity Action Plans is mandated by new provisions of the Federal Food, Drug, and Cosmetic Act, introduced by the Food and Drug Omnibus Reform Act (FDORA). These plans apply to phase 3 clinical studies or other pivotal clinical studies of drugs or biological products, as well as certain clinical studies of medical devices. These studies must serve as the primary basis for the FDA’s evaluation of the safety, effectiveness, and benefit-risk determination of the device. The requirement to submit a Diversity Action Plan applies to clinical studies whose enrollment begins 180 days after the publication of the final guidance.

Clinical Studies

FDA Prioritizes Diverse Population Data in New Clinical Studies Guidance

“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,” 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. With the implementation of FDORA, sponsors are now required to submit Diversity Action Plans, ensuring that they critically and intentionally consider the diverse characteristics of the patient population they aim to treat when designing their clinical studies.

The draft guidance was developed by the Oncology Center of Excellence Project Equity, in collaboration with various FDA centers and offices, including the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Office of Women’s Health, and the Office of Minority Health and Health Equity. This collaborative effort underscores the FDA’s commitment to improving the inclusivity and representativeness of clinical trials.

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The FDA’s draft guidance on Diversity Action Plans marks a pivotal step in enhancing the enrollment of underrepresented populations in clinical studies. By ensuring that clinical trial participants reflect the diversity of the patients who will ultimately use the medical products, the FDA aims to improve the reliability and applicability of clinical data. This initiative is part of the broader effort to ensure that medical products are safe, effective, and beneficial for all patient populations, ultimately leading to better healthcare outcomes for diverse communities.


Resource: Food and Drug Administration, June 26, 2024

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