FDA's Updated Draft Guidance On Reporting Of Diversity Data In Clinical Trials

By Susan Shorter, Senior Quality, Risk and Regulatory Specialist

The FDA has released an updated draft guidance on collecting race and ethnicity data in clinical trials and studies for FDA-regulated medical products. The purpose of the update is to standardize the approach to collecting and reporting this data to ensure consistency and accuracy. The FDA recommends using a two-question format for collecting ethnicity data and self-reporting for race data. If a more detailed breakdown is needed, the FDA provides specific categories for teams to use instead.

The data collected should be submitted for all new clinical trials and studies, and demographic data should be used when developing product labeling. Diversity in clinical trials is important to ensure the safety and effectiveness of medical products for different populations. International regulatory bodies are also requiring diverse clinical trials to ensure safety and efficacy. The comment period for the draft guidance will end on April 29, 2024.

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