Women Are Not Equally Included in All Cardiovascular Clinical Trials

And a lack of appropriate referral for trials may be a cause.

In cardiovascular clinical trials, underrepresentation of women continues to occur. To quantify this disparity and to evaluate it by disease state, the authors performed an analysis of FDA trial data from 2005 to 2015.

The examined trial data were supporting new drug applications on 35 drugs for acute coronary syndrome, atrial fibrillation, coronary artery disease, heart failure, hypertension, and pulmonary arterial hypertension. Researchers developed estimates of proportional representation by dividing the percentage of women trial participants by the percentage of women in the overall disease population.

The mean proportion of women enrolled across the clinical trials was 46% (range, 22%–81%). The proportional representation ratios for atri…

Reviewing Author

Karol E. Watson, MD, PhD, FACC

Disclosures

Consultant/Advisory BoardBoehringer Ingelheim; Amgen; Novartis; Lilly; Amarin

Speaker’s BureauBoehringer Ingelheim

Grant/Research SupportNIH

Editorial BoardsCirculation (Associate Editor)