Representation of Women in Randomized Clinical Trials of Cardiovascular Disease Prevention

Abstract

Background-The (40%), and stroke (38%) and lowest for heart failure (29%), coronary artery disease (25%), and hyperlipidemia (28%). By contrast, women accounted for 53% of all individuals with hypertension, 50% with diabetes, 51% with heart failure, 49% with hyperlipidemia, and 46% with coronary artery disease. Sex-specific results were discussed in only 31% of primary trial publications. Conclusions-Enrollment of women in randomized clinical trials has increased over time but remains low relative to their overall representation in disease populations. Efforts are needed to reach a level of representation that is adequate to ensure evidence-based sex-specific recommendations. (Circ Cardiovasc Qual Outcomes. 2010;3:135-142.)

The Impact of Cardiovascular Disease Prevalence on Women's Enrollment in Landmark Randomized Cardiovascular Trials: A Systematic Review

“…As well, previously published studies in this area have focused on specific subpopulations such as NIH prevention trials, heart failure trials, or acute coronary artery disease trials, and did not examine the entire spectrum of cardiovascular clinical trials. 4,6,8 Our paper has included trials examining different populations and has established that age plays a significant role in the underrepresentation of women regardless of the study population.…”

“…[1][2][3] This is partly because women have been substantially underrepresented in randomized clinical trials, [4][5][6][7][8] which are considered to be the most reliable form of scientific evidence that influences clinical practice. 9 For example, in the landmark Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial, more than 40,000 patients were enrolled to evaluate the safety and effectiveness of fibrinolytic therapy, but women constituted only 25% of the trial participants.…”

“…11 Despite this and numerous public initiatives to raise awareness about women and heart disease, recent data continue to show that women's enrollment lags substantially behind that of men. [4][5][6][7][8] Indeed, the reason for the persistent pattern of female underrepresentation in cardiovascular trials is largely unknown. It is well documented that patients enrolled in clinical trials are substantially different from the general population.…”

African American Women's Perceptions and Attitudes Regarding Participation in Medical Research: The Mayo Clinic/The Links, Incorporated Partnership

“…Passage of the National Institutes of Health (NIH) Revitalization Act in 1993 required that scientists receiving NIH funding for their research articulate plans to enroll minorities and women into clinical research studies. [10][11][12][13] While minority enrollment in clinical trials has generally improved, enrollment of African Americans in clinical trials remains suboptimal, particularly in trials related to cardiovascular 14 and cancer outcomes. 15 Underrepresentation of minority groups in research limits the validity and generalizability of study results, affects access to cutting-edge therapies for these groups, and propagates health disparities.…”

Adapting and RE-AIMing a heart disease prevention program for older women with diabetes

“…Despite the incidence and mortality rates of CHD in women, older women with diabetes, including Latinas, remain a largely understudied group. A comprehensive lifestyle program addressing CHD risk factors would be of enormous benefit to such persons, yet CHD risk-prevention research with older women and Latinas is very limited [6].…”