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Clinical trial enrollment among adult cancer patients in the United States is low and presents a major impediment to the advancement of cancer care and prevention. Fewer than 5% of adult cancer patients in the United States are estimated to participate in National Cancer Institute (NCI)–sponsored clinical research trials, a statistic that has been stagnant for decades (1–4). Furthermore, certain subsets of the US population, including the elderly, racial or ethnic minorities, and women, have historically been underrepresented in clinical trials (3). Underrepresentation by these groups does not reflect the heterogeneity of the US population or of cancer biology. This shortcoming of the clinical trial enterprise implies inequitable access to clinical trials, threatens the generalizability of trial results, and hinders meaningful subgroup analyses. Concomitantly, many clinical trials close with accrual insufficient to answer their scientific questions. Among phase III trials sponsored by NCI-sponsored clinical trial cooperative groups, 34% closed with insufficient accrual to address the trials’ primary endpoint (5). Furthermore, the Institute of Medicine (IOM) report “A National Cancer Clinical Trials System for the 21st Century:

Discussions About Clinical Trials Among Patients With Newly Diagnosed Lung and Colorectal Cancer