Department of Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA
Emory University Rollins School of Public Health, Atlanta, Georgia, USA.
Oncologist. 2018 Feb;23(2):243-246. doi: 10.1634/theoncologist.2017-0237. Epub 2017 Dec 19.
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.
许多已批准的药物在不同种族和族裔群体中表现出不同的药代动力学、药效学和/或安全性。本研究的主要目的是总结使用美国食品和药物管理局（FDA）于 2010 年 1 月 1 日至 2016 年 7 月 31 日期间批准的癌症药物进行的癌症临床药物试验中的种族和民族构成。在用于 FDA 批准的临床研究中，82.3%的参与者被认定为白人，10.2%为亚洲人，2.3%为黑人，4.7%为西班牙裔。黑人参与者占美国和加拿大癌症临床药物试验的 7.7%和全球癌症临床药物试验的 2.6%，而亚洲参与者占全球癌症临床药物试验的 13.5%，仅占美国和加拿大癌症临床药物试验的 1.8%。本研究表明，尽管癌症临床药物试验已经越来越多地纳入亚洲参与者，但其他种族和族裔群体仍然代表性不足。这可能导致对许多种族和族裔人群的药物安全性和疗效的理解不足。
