FDA tackles Clinical Trial Diversity – Is Congress Next? - National Health Council
The FDA issued updated draft guidance on clinical trial diversity, emphasizing Diversity Action Plans (DAPs) to improve participation of underrepresented populations in clinical trials. DAPs require enrollment goals disaggregated by race, ethnicity, sex, and age group, and strategies to achieve these goals include community engagement and cultural competency training. The guidance also outlines submission requirements for drugs and devices. The NHC supported this legislation and will provide input by September 26. Additionally, the Clinical Trial Modernization Act (CTMA) was introduced to address economic barriers to clinical trial participation, supported by the NHC.
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The FDA's draft guidance on diversity in clinical trials requires drug manufacturers to submit diversity action plans for phase 3 and pivotal trials, disaggregated by age, sex, and racial/ethnic demographics. Strategies to enhance diversity include patient engagement, culturally-competent care, recruiting from earlier studies, flexible study design, peer-to-peer referrals, community outreach, targeted marketing, and partnering with patient advocacy groups. Successful recruitment examples show diverse populations participating in trials, highlighting the importance of inclusivity for better health outcomes.
The FDA issued updated draft guidance on clinical trial diversity, emphasizing Diversity Action Plans (DAPs) to improve participation of underrepresented populations in clinical trials. DAPs require enrollment goals disaggregated by race, ethnicity, sex, and age group, and strategies to achieve these goals include community engagement and cultural competency training. The guidance also outlines submission requirements for drugs and devices. The NHC supported this legislation and will provide input by September 26. Additionally, the Clinical Trial Modernization Act (CTMA) was introduced to address economic barriers to clinical trial participation, supported by the NHC.
The FDA aims to improve enrollment of underrepresented populations in clinical studies through Diversity Action Plans (DAPs), ensuring inclusivity across age, sex, and racial demographics. The draft guidance, set to become official after a commenting period, emphasizes practical measures like transportation assistance and decentralized clinical trials to reduce participant burden. While comprehensive, the guidance may pose challenges for smaller sponsors, requiring clarity and support for effective implementation.
FDA's finalized decentralized clinical trials guidance promotes study activities at non-traditional sites, including patients' homes. The agency emphasizes diversity in study participants, plans to require 'Diversity Action Plans' (DAPs), and encourages oncology sponsors to conduct multiregional clinical trials while ensuring results apply to U.S. populations. FDA also promotes integrating real-world evidence (RWE) and data from diverse sources to support clinical development.
FDA to mandate diversity action plans for clinical trial sponsors, aiming to improve enrollment of underrepresented populations, with quotas and strategies to reflect the patient population.
FDA finalized decentralized clinical trials guidance, allowing study activities to be conducted at locations other than traditional sites, including patients' homes.
The Food and Drug Omnibus Reform Act of 2022 (FDORA) enacted on December 29, 2022, mandated drug and device sponsors to submit diversity action plans (DAPs) specifying enrollment goals by race, ethnicity, sex, and age. This was the first statutory requirement for advancing clinical trial diversity, followed by FDA's draft guidance revision on DAPs on June 26, 2024.