Racial and Ethnic Representation in US Clinical Trials of New Drugs and Biologics, 2015-2019

Abstract

This study reviews the participation of racial and ethnic populations at US sites in 2015-2019 to understand the extent to which US trial participation represents the diversity of the US population.

Figure 1.. Participants in Pivotal Trials Compared With Racial Breakdown of the US Population by Year^a

^aPer the US Food and Drug Administration (FDA) report Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products, August 2013, the FDA defines pivotal clinical trials as clinical investigations designed to collect definitive evidence of the safety and effectiveness of a medical product for a specified intended use (https://www.fda.gov/files/about%20fda/published/Collection–Analysis–and-Availability-of-Demographic-Subgroup-Data-for-FDA-Approved-Medical-Products.pdf). ^bDue to small percentages, the “other” category combines Native Hawaiian or Other Pacific Islander, unknown/unreported/missing, other race, and multiracial. ^cThe percentages of the categories Native Hawaiian or Other Pacific Islander and 2 or more races are not presented in the graph. However, absolute values from the US Census population estimates are included in calculating percentages for all other races.

Figure 2.. Participants in Pivotal Trials Compared With Ethnicity Breakdown of the US Population by Year^a

^aPer the US Food and Drug Administration (FDA) report Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products, August 2013, the FDA defines pivotal clinical trials as clinical investigations designed to collect definitive evidence of the safety and effectiveness of a medical product for a specified intended use (https://www.fda.gov/files/about%20fda/published/Collection–Analysis–and-Availability-of-Demographic-Subgroup-Data-for-FDA-Approved-Medical-Products.pdf). ^bThere were no values for missing ethnicity data in US Census estimates.