FDA Releases Draft Guidance To Encourage Enhancing Clinical Trial Diversity

The FDA has just released draft guidance in the Biden Administration’s effort to encourage the industry to enhance clinical trial diversity. 

The purpose of this guidance is to provide recommendations to sponsors developing medical products2 on the approach for developing a Race and Ethnicity Diversity Plan (henceforth referred to as the “Plan”) to enroll representative numbers of participants from underrepresented racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of color, in clinical trials.3 Individuals from these populations are frequently underrepresented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population.

Adequate representation of these populations in clinical trials and studies supporting regulatory submissions helps ensure that the data generated in the development program reflect the racial and ethnic diversity of the population expected to use the medical product if approved, and may potentially identify effects on safety or efficacy outcomes that may be associated with, or occur more frequently within these populations.

The draft guidance can be found here.  

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