Letters Section Editor: Robert M. Golub,
MD, Senior Editor.
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 identifying the underlying differences
in the representation of various groups in trial populations.
Murthy VH, Krumholz HM, Gross CP. Disparities in Participation in Cancer Clinical Trials—Reply. JAMA. 2004;292(8):922. doi:10.1001/jama.292.8.922-b
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