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Racial and Ethnic Representation of Participants in US Clinical Trials of New Drugs and Biologics

Link [2022-03-09 18:52:57]

To the Editor A Research Letter by Dr Lolic and colleagues at the US Food and Drug Administration (FDA) identified the racial and ethnic representation of participants in recent US clinical trials for new molecular entities. The authors reported that from 2015 to 2019, the proportion of Black or African American participants ranged from 15% to 19%, with yearly participation rates consistently at or above US Census level. This represents progress from previous years but is a bit misleading. The FDA provided but did not highlight data that only 3% of clinical trial participants for cardiovascular trials were Black or African American men younger than 65 years. For oncology trials, less than 5% of participants were Black men. The higher total aggregate number was dominated by infectious disease trials, in which 17% of participants younger than 65 years were Black men. Similarly, only 6% of trial participants in cardiovascular trials were Black or African American women. In oncology trials, only 2% of participants were Black women vs 84% White women.