Sex Differences in Perceived Risks, Distrust, and Willingness to Participate in Clinical Trials

Abstract

Although cardiovascular disease (CVD) is a major health care burden and the leading cause of mortality in the United States among both men and women,¹ sex differences in disease cause, progression, clinical treatment, efficacy of interventions, and cardiovascular outcomes have been recognized.^2-8 In 1993, the National Institutes of Health established requirements for equal inclusion of women in clinical studies.⁹ Subsequently, considerable attention and controversy has surrounded the issue of balanced sex representation in large clinical trials,^10-16 particularly for CVD prevention. However, previous assessments have been retrospective and have not fully evaluated the inherent difficulty of enrolling both women and men in trials for CVD prevention.