Those who work in clinical trials know very well that securing patients for enrollment in studies is hard enough. However, finding minority and racially diverse patients represents an even harder task due to a confluence of factors and forces frequently chronicled in this media platform. Now the U.S. Food and Drug Administration (FDA) issued new guidance to industry for developing plans to enroll more study participants representing underrepresented racial and ethnic populations across America, such as Blacks, Hispanic/Latinos, Asians, rural whites, the elderly, and others deemed underrepresented. With new draft guidance, is the FDA moving toward codifying equality into the clinical trials enterprise? Will this approach ultimately work? 

This draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials,” recommends that sponsors of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. 

Barriers to participation among racial and ethnic groups may include mistrust of the clinical r…