Food and Drug Administration Issues Guidance on Race and Ethnicity Diversity Plans for Clinical Trials


On April 13, the Food and Drug Administration published a draft guidance on “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry.” The guidance provides recommendations to sponsors developing human drugs and medical devices on the approach for creating Race and Ethnicity Diversity Plans (Plans) to ensure enrollment in clinical trials of underrepresented racial and ethnic populations in the United States. The guidance recommends that these Plans include defined enrollment goals for underrepresented racial and ethnic participation; how the study will design features that support safety and effectiveness of the medical product in different racial and ethnic groups; and how the study intends to capture and explore data differences in safety and effectiveness. The complete list of FDA recommendations for Plans can be found here.


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