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Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018

JAMA Oncology Aug 22, 2019

Loree JM, Anand S, Dasari A, et al. - In 230 (n = 112,293) trials resulting in FDA oncology drug approvals over the past decade, researchers assessed the frequency of race reporting and proportional race representation in trials supporting US FDA. The number of trials reporting race and race subgroup analysis altered minimally and varied across races, between July 2008 and June 2013 vs July 2013 and June 2018. Whites, Asians, blacks, and Hispanics represented 76.3%, 18.3%, 3.1% and 6.1% of trial individuals, respectively, and the proportion for each race recruited over time altered nominally from July 2008 to June 2013 vs July 2013 to June 2018. In contrast with their proportion of US cancer incidence, blacks and Hispanics were underrepresented vs whites and Asians. In conclusion, race and race subgroup analysis reporting occurs uncommonly, and black and Hispanic races are constantly underrepresented in comparison with their burden of cancer incidence in landmark trials that resulted in FDA oncology drug approvals. Improved minority engagement is required in trials to ensure the validity of outcomes and reliable advantages to all.
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