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FDA can require or request that information on safety and effectiveness for underrepresented patients be collected in the postmarketing setting.

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Reviews of clinical trial data indicate that there is persistent underrepresentation of patient populations based on race, ethnicity, sex and age.

FDA continues to encourage early collaboration between drug sponsors and FDA review divisions as a key to enabling inclusive clinical trial recruitment strategies.

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In a notable step toward more equitable healthcare, the U.S. Food and Drug Administration (FDA) introduced new draft guidance on August 10, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products,to address the underrepresentation of diverse populations (e.g., populations based on race, ethnicity, sex or age) in clinical trials. This guidance provides recommendations to help sponsors obtain safety and effectiveness information on drugs, when appropriate, in the postmarketing setting in historically underrepresented patient populations in clinical trials.

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Diverse representation in clinical trials is crucial for several reasons. Disease occurrence, outcomes and responses to drugs can vary significantly among different demographic groups. Recognizing this, FDA continues to take steps to improve inclusivity and gather more comprehensive data to support drug approval and usage decisions.

This draft guidance emphasizes the importance of obtaining information on the safety and effectiveness of drugs across a diverse patient population. This approach not only enhances the reliability of trial results but also supports better understanding of how different groups may respond to medications.

FDA has already taken proactive measures to encourage diversity in clinical trials. By publishing guidance documents and organizing workshops, the agency aims to engage stakeholders and raise awareness about the significance of inclusive representation in trials. These efforts ultimately contribute to more accurate and reliable insights into a drug’s effects on various populations.

Specifically, this guidance focuses on postmarketing data collection. FDA emphasizes mechanisms such as Postmarketing Requirements and Postmarketing Commitments as vehicles to gather data on traditionally underrepresented populations where, despite the sponsor’s best efforts, these populations are not adequately represented in premarket clinical trials. These mechanisms can ensure that the safety and efficacy of drugs continue to be monitored even after the drugs are approved and are available in the market.

The guidance also highlights considerations for various postmarketing approaches to obtaining additional information on traditionally underrepresented populations. Whether through single-arm trials, randomized trials, or the leveraging of real-world data sources like electronic health records and registries, the FDA encourages a more comprehensive understanding of a drug’s effects across diverse groups. The guidance sets forth specific considerations for each type of approach to incorporating data from diverse populations.

Early collaboration between drug sponsors and FDA review divisions is another key aspect recommended by FDA to enable recruitment strategies for underrepresented populations. This approach allows for the development of effective plans that promote inclusivity from the outset of clinical trials. Finally, FDA stresses that while foreign clinical data can be submitted in support of a marketing application, FDA may request or require studies or trials to further characterize the efficacy and safety of the product in relevant U.S. subpopulations.

FDA’s new guidance signals another proactive approach toward ensuring diversity in clinical trials. By promoting inclusivity, the agency aims to ensure that the benefits and risks of drugs are understood across a wide spectrum of patients, including underrepresented populations. These efforts have the potential to lead to more informed healthcare decisions and improved outcomes for patients.

Please contact your BakerHostetler connection or Winston Kirton, Payal Cramer or Laura Macherelli with any questions on this new FDA guidance. FDA is accepting comments and suggestions regarding the draft guidance until around October 10, 2023.

FDA Issues New Guidance for Collecting Postmarketing Data on Underrepresented Patient Populations

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