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July 15, 2021

Promoting Inclusion of Members of Racial and Ethnic Minority Groups in Cancer Drug Development

Author Affiliations
  • 1Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland
JAMA Oncol. 2021;7(10):1445-1446. doi:10.1001/jamaoncol.2021.2137

Members of racial and ethnic minority groups in the US are frequently underrepresented in clinical trials submitted to the US Food and Drug Administration (FDA) to support approval of anticancer therapeutics.1,2 The FDA has long held the view that trials should represent the populations for which the therapeutic is intended to ensure external validity of results. The FDA recommendations to improve trial diversity address the collection and analysis of data on racial and ethnic minority groups, describe considerations for broadening eligibility, and encourage discussions with the appropriate division at the FDA regarding enrollment plans.3,4 External stakeholders have also recommended that pharmaceutical companies develop a plan that outlines measures to ensure diverse clinical trial participation.5 In oncology, a greater reliance on small studies, intermediate and early end points, and innovative trial designs to expedite drug development and approval underscore the need to prospectively define such a plan.

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