The Food and Drug Administration (FDA) recently released a draft guidance aiming to improve the diversity of participants in clinical trials by establishing a framework for diversity action plans. This initiative, prompted by legislation passed by Congress in 2022, mandates that drug and device makers submit these plans to the FDA. The legislation set a deadline for the FDA to issue detailed guidelines by December 29, 2023, specifying the content and format of these diversity action plans.
Key to the FDA’s guidance is defining which clinical trials will be required to adhere to the new diversity standards. Specifically, the agency indicated that it will only require diversity action plans for studies that provide definitive evidence regarding the safety and effectiveness of a device for a specified use. Smaller studies conducted during the exploratory phase, or other studies not aimed at definitive evidence generation, although not required to, are still encouraged strongly by the FDA to develop diversity strategies.
The narrative regarding diversity within the clinical trials is expected to shift significantly as this initiative takes root. Drug and device trial sponsors are now tasked with setting specific commitments for participant diversity. According to the draft guidance, these diversity action plans must detail enrollment goals broken down by race, ethnicity, sex, and age group, corresponding with the clinically relevant population. These targets should ideally reflect the estimated prevalence or incidence of the condition under study.
The plans must also outline the rationale behind these enrollment goals and identify actionable strategies on how they will be met. While the legislation itself did not delve into the specifics of the plan’s presentation (“form and manner”), the FDA’s draft guidance provides that needed clarity, ensuring that sponsors have a clear framework within which to structure their submissions.
The implementation schedule for these regulations indicates that clinical trials expected to start enrollment 180 days after the FDA publishes its final guidance on the subject will need to comply with these new requirements. However, the FDA proposes some leeway for transition; particularly, sponsors that file applications for Investigational Device Exemption (IDE) trials within 180 days after the publication of the final guidance will not be required to have a diversity action plan. Likewise, non-IDE trials that have been approved by an institutional review board or independent ethics committee within this same timeframe are also exempt.
As part of the process, the FDA has opened the draft guidance for public comment, allowing a 90-day period during which sponsors can provide feedback and express concerns regarding the agency’s interpretation of the new legal mandates, including aspects like the definition and sharing of enrollment goals.
This strategic move by the FDA aims to foster more inclusive clinical trials, ensuring that trial populations better represent the demographics of those afflicted by various diseases or conditions. Achieving this goal not only improves the generalizability of trial outcomes but ensures equity in how new medical breakthroughs are tested. The insights gleaned from a more diverse trial cohort are crucial for understanding different impacts and effectiveness across a varied population, ultimately leading to enhanced healthcare outcomes.
The FDA’s guidance is a step forward in adapting clinical practices to societal needs, emphasizing the importance of diversity and inclusivity in research that shapes future medical practice and interventions. Such regulatory frameworks signal a growing recognition of the need for research environments that reflect and address the diversity of the patient populations they aim to serve. This move is likely to pave the way for more nuanced and universally applicable healthcare solutions, enhancing treatment efficacy and safety across different demographic groups.
#FDA #shares #draft #guidance #clinical #trial #diversity #action #plans
