Ethnic and racial minorities are commonly underrepresented in clinical trials. This problem is so severe that in April, the U.S. Food and Drug Administration (FDA) expanded upon existing guidance to further emphasize recommendations to sponsors developing treatments to increase enrollment from underrepresented populations in the U.S., including African-American, Hispanic, Asian and other persons of color, in clinical trials. In the updated guidance, the FDA provided details on what sponsors should include in a Race and Ethnicity Diversity Plan when submitting for an investigational new drug (IND) application or a new drug application (NDA).
