The FDA has released updated guidance aimed at ensuring greater diversity in clinical trials, reflecting a commitment to include a broader range of patients in the development of new therapies. This initiative mandates that trial sponsors develop and submit diversity action plans (DAPs) to increase the enrollment of participants from historically underrepresented communities.
The updated guidance, prompted by the Food and Drug Omnibus Reform Act (FDORA) and the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act of 2022, specifies how trial sponsors should structure DAPs. These plans are designed to ensure that clinical trials more closely mirror the demographic makeup of the population that will ultimately be treated with the new therapies.
Addressing Underrepresentation
Despite ethnic and racial minorities comprising over 40% of the U.S. population, they typically represent only 5% to 10% of clinical trial participants. This underrepresentation raises concerns that new therapies may not be as effective or could even be harmful to non-white individuals. For instance, a 2022 IQVIA report indicated a decline in Black/African American participation in trials over the past decade, linked to mistrust of the healthcare system.
Richard Pazdur, director of the FDA’s Oncology Center of Excellence, emphasized the importance of these 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.”
Key Components of Diversity Action Plans
The FDA's guidance outlines that DAPs must be prepared for pivotal trials of new drugs. The agency also recommends that sponsors develop a diversity strategy across the entire clinical development program, including in early studies. These plans must include:
- The sponsor’s goals for enrollment, disaggregated by race, ethnicity, sex, and age group of clinically relevant study populations.
- The rationale behind these goals.
- A detailed explanation of how the sponsor intends to meet these goals.
Impact and Implementation
US Representative Anna Eshoo (D-CA), a key figure behind the DEPICT Act, welcomed the FDA’s actions, stating, “Clinical trials have failed to achieve a level of diversity that reflect the American population for decades. I applaud the FDA’s steps to implement my legislation to address this inequality and look forward to the agency finalising guidance on the Diversity Action Plans to ensure clinical trials are representative of all Americans.”
The guidance is open for public comment until September 26th. Once finalized, trial sponsors will have 180 days to comply. This updated guidance represents a significant step toward ensuring that clinical trials are more inclusive and representative of the diverse populations they aim to serve, ultimately leading to more effective and equitable healthcare outcomes.
