Representation of the Elderly, Women, and Minorities in Heart Failure Clinical Trials

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Abstract
RANDOMIZED controlled trials (RCTs) are considered to provide the highest level of evidence for clinical practice, but several studies have suggested that RCTs often do not enroll subjects who are representative of patients seen in the community.1-6 The infrequent enrollment of older patients, women, and minorities has raised specific concerns about the generalizability of medical evidence to these important patient groups. In response to concerns about clinical trial generalizability and equity, the US Congress included requirements for the inclusion of women and minorities, but not the elderly, in the National Institutes of Health (NIH) Revitalization Act of 1993 (Public Law 103-143).7,8

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