By Jonathan Springston, Editor, Relias Media

Women, especially those who belong to ethnic and racial minority groups, are not properly represented in cardiology-related clinical trial research, according to a recent report from the American College of Cardiology Cardiovascular Disease in Women Committee.

The report authors listed several reasons they believe this problem remains, including ageism, not enough women in clinical trial research leadership roles, and a general lack of awareness. The committee also listed more specific causes, such as the fact pregnant women often are excluded from clinical trials over perceived and poorly defined vulnerabilities as well as the fact there are some differences in disease presentation between the sexes (e.g., women develop certain types of heart disease that are different than what men experience).

“Historically, drug therapies for women were determined based on male data that was extrapolated to women. 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,” Leslie Cho, MD, FACC, lead author, said in a statement. “To address barriers to recruitment and retention of women in cardiovascular clinical trials, a comprehensive and targeted approach that involves partnership with all stakeholders — patients, referring clinicians, research teams (investigators and coordinators), healthcare systems, the FDA, payers, sponsors, professional and community organizations — is essential.”

In May, the authors of a different study reported that although sex was noted in 98% of 688 clinical trials (of all types) conducted between 2015 and 2019 that they reviewed, the median number of female participants was 46%. Further, not even half these trials included information about race; among those with such data, 84% of participants in 2015 were white (77% in 2019).

Still, awareness about diversity in clinical trial research appears high. The American Medical Association, the National Academy of Medicine, and the American Heart Association/American College of Cardiology all released new guidance and reports in 2021 about ways to make research more inclusive. In April, PRA Health Sciences, a contract research organization in Raleigh, NC, sponsored a virtual event where several experts spoke at length about inclusion in clinical trials.

For more on this and related subjects, please read the latest issues of Medical Ethics Advisor.