Racial and Ethnic Composition of Cancer Clinical Drug Trials: How Diverse Are We?

Many approved drugs demonstrate different pharmacokinetics, pharmacodynamics, and/or safety across racial and ethnic groups. The primary objective of the current study was to summarize the racial and ethnic makeup of cancer clinical drug trials using cancer drugs approved by the U.S. Food and Drug Administration (FDA) between January 1, 2010, and July 31, 2016. In clinical studies used for FDA approvals, 82.3% of participants identified as white, 10.2% as Asian, 2.3% as black, and 4.7% as Hispanic. Black participants made up 7.7% of U.S. and Canadian cancer clinical drug trials and 2.6% of global cancer clinical drug trials while Asian participants made up 13.5% of global cancer clinical drug trials but only 1.8% of U.S. and Canadian cancer clinical drug trials. The current study indicates that although cancer clinical drug trials have become more inclusive of Asian participants, other racial and ethnic minority groups remain under‐represented. This may result in an inadequate understanding of drug safety and efficacy in many racial and ethnic populations. The lack of racial and ethnic diversity in clinical drug trials is not only a scientific concern but also an ethical one. The lack of inclusion of under‐represented populations in clinical drug trials could be viewed as yet another health disparity befalling populations that are already more at risk of substandard health care. This article summarizes the racial and ethnic makeup of cancer clinical drug trials using cancer drugs approved by the FDA between January 1, 2010, and July 31, 2016.