FDA guidance on racial and ethnic diversity in clinical trials

On Wednesday, the US Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the USA into clinical trials – expanding on the agency’s previous guidance for industry to improve clinical trial diversity.

Despite having a disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in biomedical research. Clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective; therefore, enrollment in clinical trials should reflect the diversity of the population that is ultimately going to use the treatment. It is known that biological differences exist in how people respond to certain therapies.

This draft guidance, “ Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials,” recommends that sponsors of medical products develop and submit a Race and Ethnicity Diversity Plan to the agency early in clinical development, based on a framework outlined in the guidance.