Studies Raise Warnings About Underrepresentation of Women in Cardiovascular Clinical Trials

Woman being checked with a stethoscope

Women remain underrepresented in cardiovascular clinical trials despite guidelines and legal requirements developed almost 30 years ago to ensure broader inclusivity, according to recent reports in the Journal of the American College of Cardiology (ACC) and the European Heart Journal. This lack of representation can limit availability of treatment data on the number one killer of women worldwide—cardiovascular disease.

“Historically, drug therapies for women were determined based on male data that [were] extrapolated to women,” said Leslie Cho, MD, FACC, lead author of the American study, a member of the ACC Cardiovascular Disease in Women Committee, and director of the Women’s Cardiovascular Center at Cleveland Clinic. “However, research has shown that women respond differently than men and may even be harmed or experience side effects from some drugs when taken at the same dosage as men. Sex-specific data [are] essential to optimal care.”

The committee issued its report to better understand the current barriers to enrollment and retention of women in clinical trials, as well as to offer novel strategies to help increase participation of women and, more specifically, underrepresented minority women, while also looking at women of childbearing age and pregnant women. Among the barriers noted in the report is the fact that previous surveys and studies have shown that women are more reluctant than men to participate in clinical trials, and that women are underrepresented in clinical trial leadership. Research has shown that trials led by women tend to recruit more women participants. Further, pregnant women and women of “child-bearing potential” are frequently excluded from clinical research as a vulnerable population, resulting in not only reduced numbers of eligible women, but a lack of data on how certain drugs impact pregnant patients.

Meanwhile, authors of the European study reported that women must be equally represented in heart disease research to ensure that treatment recommendations meet their specific health needs.

“For many years it was usual practice that studies on heart disease primarily included white men,” said author Dr. Jeske van Diemen of Amsterdam University Medical Centre, the Netherlands. “It was assumed that the results were also relevant to women and other races, but evidence is emerging that this is not the case. …Within our own research group, we noticed how hard it was to recruit women. We therefore decided to examine current evidence on reasons to agree or decline participation, with the aim of coming up with solutions to increase gender balance in cardiovascular trials.”

The authors performed an extensive literature search for articles addressing the motivators, facilitators, and barriers to enrolment and continued participation. For both men and women, motivators included the possibility of accessing better and more continuous care, and altruistic values such as the desire to promote science. None of the studies reported on facilitators to improve sign-up rates in women, but the authors noted that a high socioeconomic position was associated with an increased willingness to participate among women. They said that this may marginalize women with a lower socioeconomic position, who stand to benefit the most from better representation. They also noted how involving women in the design and conduct of cardiovascular trials may aid recruitment. Logistical support could also help, such as transportation to clinical trial sites and onsite childcare.

Edited by Gary Cramer