The FDA this week issued a draft guidance about diversity in medical product clinical trials.
The draft guidance, titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” aims to help medical product sponsors submit Diversity Action Plans to support certain clinical studies. Diversity Action Plans help increase clinical study enrollment of participants in historically underrepresented populations and improve data that the FDA receives from the trials.
Diversity in clinical trials helps enhance the understanding of diseases and medical products being studied and facilitates a broader use for a broad spectrum of patient populations, the FDA said in a news release.
“Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data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.”
How the draft guidance enforces diversification
This FDA draft guidance describes the format and content of the Diversity Action Plans, the medical products and clinical studies that require the plans and the timing and process for submitting Diversity Action Plans. The FDA also outlines the criteria and process the agency will use to evaluate a company’s request not to submit a Diversity Action Plan.
Diversity Action Plans include information such as a sponsor’s rationale and goals for clinical study enrollment, separated by age group, ethnicity, sex and race of clinically relevant study population, and how it plans 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 agency said in a news release.
According to the FDA, the new Diversity Action Plan submission requirement stems from new provisions of the Federal Food, Drug, and Cosmetic Act added by the Food and Drug Omnibus Reform Act (FDORA). The plans apply to phase 3 clinical studies or other pivotal clinical studies of certain devices, including those intended to serve as the FDA’s primary basis for safety and effectiveness evaluation and benefit-risk determination of a device.
Diversity Action Plan submissions will apply to clinical studies in which enrollment begins 180 days after the final guidance is published.
“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, 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.
