In a move that has sparked widespread concern, the FDA quietly removed its draft guidance on diversity in clinical trials from its website. The removal came days after an executive order by President Donald J. Trump limiting diversity, equity, and inclusion (DEI) programs and federal recognition of gender identity apart from biological sex.
The draft guidance, originally issued in June 2024, aimed to improve the inclusion of underrepresented populations in clinical research. The sudden deletion, discovered by the public on January 23, 2025, has left stakeholders questioning the FDA’s commitment to inclusivity in clinical trials and its compliance with statutory obligations under the Food and Drug Omnibus Reform Act (FDORA).
Historical Context of Diversity in Research
The FDA’s history with diversity in clinical trials has been fraught with challenges. In 1977, the agency discouraged the participation of women of childbearing age in clinical research due to concerns about fetal harm. This policy exacerbated gender disparities in research, particularly in areas like cardiovascular disease, where sex-specific differences went largely unstudied.
Recent efforts, including the draft guidance issued in 2024, sought to rectify these issues by mandating inclusive practices. By focusing on demographic diversity, the guidance aimed to improve the generalizability of clinical trial results and ensure that medical products meet the needs of all patient populations.
Why Diversity Matters: A Foundation for Reliable Clinical Data
Diversity in clinical trials is crucial for generating reliable data that reflects the demographics of the populations that will ultimately use the medical products being studied. Historically, clinical research has often excluded women, racial and ethnic minorities, people of varying age groups and other underrepresented groups, leading to findings that are not universally applicable. For example, cardiovascular disease research has predominantly focused on men, leaving significant gaps in understanding how the condition affects women differently.
The FDA’s draft guidance was designed to address these disparities by requiring sponsors to submit Diversity Action Plans (DAPs). These plans outlined enrollment goals for clinical trials, disaggregated by race, ethnicity, sex, and age, as well as strategies to overcome barriers to participation. The goal was to ensure that trial outcomes were generalizable across diverse populations, thereby improving the safety and efficacy of medical products for all patient groups.
The Importance of the Now-Removed Draft Guidance
The draft guidance, originally issued in June 2024, was designed to promote the enrollment of participants from historically underrepresented populations in clinical trials involving drugs, biological products, and medical devices. Recognizing the importance of diversity for generating reliable and broadly applicable data, the FDA mandated that sponsors submit Diversity Action Plans (DAPs) as part of their investigational new drug (IND) applications or premarket submissions. This requirement was aligned with sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act.
The draft guidance provided a detailed framework for sponsors to develop and implement Diversity Action Plans. These plans were expected to include:
Enrollment Goals: Specific targets for recruiting participants based on demographics like race, ethnicity, sex, and age.
Rationale for Goals: Justifications for why these targets were necessary for the study’s objectives.
Strategies for Recruitment: Methods for achieving these goals, such as community engagement, cultural competency training for researchers, and outreach to underrepresented populations.
The guidance also emphasized the importance of addressing barriers to participation, such as mistrust in the medical system and logistical challenges like transportation or childcare. Recommendations included working with community health advocates, offering flexible study designs, and training staff to interact effectively with diverse populations.
Potential Health and Industry Consequences
Some see the sudden removal of the guidance as part of a broader rollback of DEI efforts within federal agencies under the current administration. Industry experts warn that this shift may jeopardize ongoing efforts to improve research inclusivity and generalizability of clinical findings.
The exclusion of diverse populations from clinical trials has historically led to medical treatments and guidelines that are less effective for marginalized groups. For instance:
Racial and Ethnic Representation: Insufficient participation by racial minorities can obscure how treatments affect these populations differently.
Sex Representation: Including both male, female and intersex participants ensures that findings are applicable across the human biological spectrum, including diverse gender identities.
Age Representation: Pediatric and geriatric populations often respond differently to treatments, making their inclusion essential.
Conclusion
The FDA’s decision to remove its draft guidance on diversity in clinical trials without explanation has raised serious questions about its commitment to inclusivity and its ability to meet legal obligations under FDORA. As the healthcare industry navigates this uncertain landscape, the need for clear, actionable guidelines has never been more critical. Ensuring diverse representation in clinical trials is not just a regulatory requirement—it is an imperative for advancing healthcare research and improving outcomes.
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