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

Milena Lolic; Richardae Araojo; Melvyn Okeke; Janet Woodcock

doi:10.1001/jama.2021.16680

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

JAMA. 2021 Dec 7;326(21):2201-2203. doi: 10.1001/jama.2021.16680.

Authors

Milena Lolic¹, Richardae Araojo¹, Melvyn Okeke², Janet Woodcock¹

Affiliations

¹ Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland.
² Center for Biologic Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.

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.

Publication types

Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

Biological Products / therapeutic use
Clinical Trials as Topic / statistics & numerical data*
Drug Therapy
Ethnicity / classification*
Ethnicity / statistics & numerical data
Hispanic or Latino / statistics & numerical data
Humans
Pharmaceutical Preparations*
Racial Groups / classification*
Racial Groups / statistics & numerical data
United States / ethnology
United States Food and Drug Administration

Substances

Biological Products
Pharmaceutical Preparations