New research published in the Journal of the American College of Cardiology found that although the number of women participating in cardiovascular disease clinical trials has increased since the 1990s, the amount of representation varies significantly depending on the type of trial.
The study reviewed 36 cardiovascular disease drug trials from 2005 to 2015 to find whether gender differences influenced results of drug safety and efficacy.
Overall, the authors found few differences between sexes, but they did find something else: the number of women participating in these trials ranged from 22% to 81%. Women were under-represented for trials of acute coronary syndrome, heart failure, and coronary artery disease, some of the most common cardiovascular diseases.
“We hypothesized that there are unknown factors in the ‘pre-screening’ environment whereby women are not being invited or considered for clinical trial participation and therefore do not have the opportunity to participate,” said Marjorie R. Jenkins, co-author of the study and Director of Medical Initiatives and Scientific Engagement at the US Food and Drug Administration’s Office of Women’s Health in an interview with Medical Bag “This is a gap in knowledge and an area of research needed to better clarify why women’s participation is lower in some types of cardiovascular clinical trials.”
The study authors offered some factors that may influence the number of women participants, including advanced age at disease onset or presence of other medical conditions.
“Better understanding of the reasons why women are not invited, or if invited do not participate, could lead to more successful engagement and recruitment of women in clinical trials,” Dr Jenkins said.
Scott PE, Unger EF, Jenkins MR, et al. Participation of women in clinical trials supporting FDA approval of cardiovascular drugs. J Am Coll Cardiol. 2018;71(18):1960-1969.