Sex Disparities in Cardiovascular Device Evaluations
- Ghare MI, Chandrasekhar J, Mehran R, et al.
- Sex Disparities in Cardiovascular Device Evaluations: Strategies for Recruitment and Retention of Female Patients in Clinical Device Trials. JACC Cardiovasc Interv 2019;12:301-308.
The following are key points to remember from this viewpoint on sex disparities and strategies for recruitment and retention of female patients in clinical device trials:
- Cardiovascular disease is the leading cause of death for women in the United States, accounting for an estimated 400,000 deaths in women each year. Despite evidence to suggest significant sex-related differences in cardiovascular outcomes, the number of women enrolled in clinical device trials remains low. This published viewpoint was written by members of the Women in Innovation subcommittee of the Society for Cardiac Angiography and Intervention, to highlight disparities in clinical trials and review causes of these disparities.
- Participation of women in clinical trials in the United States is lower than many other areas of the world. As noted in the National Institutes of Health (NIH) Office of Research on Women’s Health review, several barriers to the participation of women in research are present. Women participants face obstacles including concerns regarding potential adverse events, reduced trust in researchers, and study burden. Patient predictors of nonparticipation include age, female sex, study duration, intensive testing, transportation, and potential for adverse events.
- Women investigators may assist in enrollment and retention of women participants by understanding the potential barriers faced by women and by demonstrating diversity in research teams. Designing clinical trials with patient-focused education and brochures, clearly outlined benefits (and risk) for participation, and reducing barriers related to transportation and childcare will assist to increase participation of women in clinical trials. Cultural, social, and behavioral factors that facilitate recruitment of women should be identified during study design to facilitate enrollment and retention of women in clinical studies.
- The NIH has published a strategic plan for women’s health research. Six goals identified include: 1) increase sex-specific research in basic science; 2) include results of sex differences in the design and application of new technologies; 3) actualize personalized prevention, diagnostics, and therapies for girls and women; 4) create strategic alliances and partnerships to maximize the national and international impact of women’s health research; 5) develop and implement new communication and social networking technologies to increase understanding and appreciation of women’s health research; and 6) use innovative strategies to build a well-trained, diverse, and vigorous women’s health research workforce.
- It is critical to include women clinical investigators in clinical trials to enhance participation of women in clinical research. Training and mentoring the next generation of female scientists should be a priority for all of us.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease, Interventions and Imaging, Angiography, Nuclear Imaging
Keywords: Angiography, Cardiology Interventions, Clinical Trials as Topic, Coronary Artery Disease, Cardiovascular Diseases, Mentors, Research, Risk Assessment, Sex Characteristics, Women's Health, Women
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