A study found women trial subjects are not proportionate to their population percentage
Women are under represented in clinical trials on heart diseases, but over represented in hypertension trials.
These are the findings of a study in the Journal of the American College of Cardiology. Heart disease is the No. 1 killer of women and men. It represents a very significant health concern for women because it is often overlooked as a prominent health issue. There are, in addition, sex and gender differences in cardiovascular disease pathophysiology, clinical presentation and outcomes. It is suspected that treatments for men may not always work as well in women.
Women being well-represented in clinical trials is important to determine possible gender differences in treatment responses.
In this study, researchers looked at the numbers of women and men who participated in cardiovascular trials submitted to the U.S. Food and Drug Administration supporting new drug application approvals.
Women being well-represented in clinical trials is important to determine possible gender differences in treatment responses.
Between Jan. 1, 2005 and Sept. 15, 2015, 36 approvals for 35 drugs for acute coronary syndrome/myocardial infarction, atrial fibrillation, coronary artery disease including angina, heart failure, hypertension and pulmonary arterial hypertension, were looked at for the percentage of women enrolled.
“As we move into the era of precision medicine, that is assessing the impact of a wide range of patient and disease characteristics on drug effects, it is imperative that clinical trial participants represent the full spectrum of patients for whom the drug will be prescribed,” said Janet Woodcock, MD, senior author of the study and director of the FDA Center for Drug Evaluation and Research. “This will move us closer to our goal of providing the best information possible about the use of drugs for every patient.”
According to the researchers, previous studies have suggested that clinical trial inclusion and exclusion criteria disproportionately exclude women from cardiovascular studies. However data in this latest study show that the lower enrollment of women reflects the lower number of women referred for pre-trial participation screening.
