HQ Team
June 27, 2024: In a bid to include an under-represented population, the US drug regulator has advised healthcare firms to improve racial, ethnic and other diversity factors during clinical trials.
The US Food and Drug Administration’s draft guidance includes suggestions for companies and researchers conducting trials on how to set goals for study enrollment, separated by age group, ethnicity, sex and race, and describe how they intend to meet those goals.
Enhancing diversity within clinical studies facilitates broader applicability of results across a broad spectrum of patient populations, and enhances understanding of the disease or medical product under study, according to an FDA statement.
It provides valuable insights to inform the safe and effective use of medical products among patients.
‘Important step’
“Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, MD.
“The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data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.”
The draft guidance describes the format and content of Diversity Action Plans, the medical products and clinical studies for which a Diversity Action Plan is required, as well as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The draft guidance also outlines the criteria and process the agency will use to evaluate a sponsor’s request not to submit a required Diversity Action Plan, also known as a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.
FDORA
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 enrol populations that represent the patients who will be treated if the product is approved.
“The requirement to submit a Diversity Action Plan applies to clinical studies for which enrolment begins 180 days after publication of the final guidance,” according to the FDA statement.
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).
“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, MD, director of the FDA’s Oncology Center of Excellence.
“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,” he said.
