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. 2018 Feb;23(2):243-246.
doi: 10.1634/theoncologist.2017-0237. Epub 2017 Dec 19.

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

Leslie J Dickmann  1   2 , Jennifer L Schutzman  3
Affiliations

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

Leslie J Dickmann et al. Oncologist. 2018 Feb.

Abstract

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.

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Conflict of interest statement

Disclosures of potential conflicts of interest may be found at the end of this article.

Figures

Figure 1.
Figure 1.
Race and ethnicity information for cancer clinical drug trials for drugs approved by the U.S. Food and Drug Administration between January 1, 2010, and July 31, 2016. U.S. population statistics (2010) were taken from the U.S. Census Bureau website. It is estimated that <5% of participants in the U.S. and Canadian studies were treated at Canadian clinical sites (see Materials and Methods section). (A): Analysis based on race, where n = 82,897 for global studies and n = 8,641 for U.S. and Canadian studies. (B): Analysis based on Hispanic ethnicity, where n = 17,387 for global studies and n = 3,148 for U.S. and Canadian studies.
Figure 2.
Figure 2.
Race and ethnicity information for cancer clinical drug trials used for approvals by the U.S. Food and Drug Administration between January 1, 2010, and July 31, 2016. (A): Analysis based on race, n = 25,220. (B): Analysis based on Hispanic ethnicity, n = 5,227.
See this image and copyright information in PMC

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