Women in clinical research: what we need for progress.

Abstract

This Go Red for Women® theme collection of articles in Circulation: Cardiovascular Quality and Outcomes presents several interesting studies focused on women’s health.1–10 The publication of this grouping provides an opportunity to reflect on the state of research into women’s heart health, the challenges ahead, and what is needed for progress. Despite the many successful campaigns raising awareness about heart disease in women, the inclusion of women in cardiovascular clinical research is a relatively recent occurrence. Before 1993, many large cardiovascular trials, including the Physicians’ Health Study11,12 and the Multiple Risk Factor Intervention Trial (MRFIT),13,14 studied only men. Concerns in the 1980s about sex equity in research led to 2 federal mandates for the inclusion of women in clinical trials. The National Institutes of Health Revitalization Act of 1993 required that all clinical trials funded by the National Institutes of Health include women as subjects and adequately power their samples to perform sex-specific analyses.15,16 Similarly, the Food and Drug Administration’s Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs called for the examination of sex differences in pharmaceutical trials.17 These policies marked a seminal advancement in women’s health research and set the precedent for subsequent guidelines and reports. Since the National Institutes of Health Revitalization Act, the absolute number of women in clinical trials has increased.18 However, recent reports show that women remain woefully under-represented in trials of cardiovascular disease prevention and treatment19–22 and that the relative proportion of women …