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In Reply: We agree that the process of recruiting trial participants—exclusion criteria being one aspect of this process—can affect the representativeness of the study sample and the generalizability of the results. Given that older and minority patients are more likely to have a higher burden of comorbid disease, it is likely that comorbid illness itself is a significant barrier to trial participation and may account for some of the observed race- and age-based disparities. While we noted that "stringent trial exclusion criteria may also contribute to disparities in trial eligibility," we did not have data available to investigate the relation between trial eligibility and race, age, and sex. Unfortunately, our recent work suggests that many published manuscripts do not report data on the trial screening and recruitment process.¹ It is unclear why such data are not collected or reported. What is certain is that their absence represents a barrier to . . . [Full Text of this Article]

Vivek H. Murthy, MD, MBA; Harlan M. Krumholz, MD, SM; Cary P. Gross, MD
cary.gross@yale.edu
Yale University School of Medicine
New Haven, Conn