Women remain underrepresented in revascularization trials—can cardiology leaders reverse that trend?
Women are severely underrepresented in clinical trials focused on coronary revascularization, according to a new commentary published in JAMA Cardiology.[1] The authors emphasized that stakeholders will need to work together if this trend is ever going to change.
“Cardiovascular disease is the No. 1 cause of death among both men and women in the U.S., yet decades of cardiovascular clinical trials have persistently enrolled a predominantly male population,” wrote co-authors Celina M. Yong, MD, MBA, MSc, and William F. Fearon, MD, two cardiologists with the division of cardiovascular medicine at Stanford University. “Among all types of cardiovascular trials, coronary revascularization trials rank at the bottom in terms of representation by sex, with an average of 27% females enrolled across 141 coronary artery disease and 61 acute coronary syndrome trials from 2010 to 2017. Despite recent concerted efforts to improve equity of trial enrollment, revascularization trials face ongoing challenges that deserve specific attention.”
Yong and Fearon noted that women should represent at least half of all patients included in U.S. revascularization trials. However, this isn’t as easy to achieve as it should be for multiple reasons.
For example, the two co-authors explained, one of the many differences in how heart disease is treated among men and women is that women are less likely to undergo percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) than men. Also, data from the Nationwide Inpatient Sample suggests that “a larger proportion of women receive PCIs outside of the institutions where registries routinely collect data and where most clinical trials are currently performed.” This suggests that changes in recruitment strategies may be necessary before real change can be achieved.
Another ongoing challenge is the fact that women tend to have more day-to-day burdens related to “childcare and family responsibilities,” making it harder for them to agree to the long-term commitments associated with clinical trial participation following PCI or CABG.
“Although some trials reimburse patients, this is often insufficient to cover both the actual and the opportunity costs associated with participation, leading to additional disproportionate barriers,” Yong and Fearon wrote. “Even when this is not the case, implicit bias may lead to the perception that a female candidate may not be appropriate. More research to understand the perspectives of women patients and their practitioners is needed.”
The two co-authors noted that changes in clinical trial leadership have been associated with improved patient representation. However, with the percentage of women in interventional cardiology being as low as 5% by some calculations, getting enough women in leadership positions to truly make an impact could quite the struggle. Also, simply waiting for more women to get involved so that more women can be recruited is not enough—to truly make a difference, clinical trial leaders must truly make equal representation a priority. This means accepting a recruitment period that is longer than average when necessary, Young and Fearon wrote, or exploring if artificial intelligence could potentially make an impact.
“Instituting these outcomes-based measures will only be successful if all stakeholders across the clinical trial spectrum are aligned, ranging from funders to journal editorial boards to trialists to clinicians and their patients,” the duo concluded. “If together we do not just hope for, but demand, adequate representation as a necessary criterion for high-quality studies worthy of adoption into practice, we will have a real shot at achieving true equity in our trials.”
Read the full editorial in JAMA Cardiology here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.