Clinical trial sponsors must step up their efforts to address underrepresentation of women among trial subjects, FDA Commissioner Scott Gottlieb said Wednesday during a meeting in White Oak, Maryland, to commemorate National Women’s Health Week. He cited the FDA-led Decadal Review that studied clinical trial efficacy and safety by sex for 34 drugs and five cardiovascular disease indications over a 10-year period from 2005 to 2015. The study analyzed the inclusion and exclusion criteria for five of the trials to get a clearer picture of whether such criteria affected subject enrollment. The results, Gottlieb said, indicated there were minimal gender differences in drug profiles, and that while women were well-represented in trials for hypertension and atrial fibrillation drugs and overrepresented for pulmonary arterial hypertension (PAH) drugs, they were underrepresented in trials for heart failure, acute coronary syndrome and coronary artery disease drugs. “These findings support the need for the FDA to issue a call to action to clinical investigators. In this case, the bottom line was that more work is needed to identify factors leading to under-participation of women in cardiovascular clinical trials in certain areas, notably heart failure, coronary artery disease and acute coronary syndrome,” Gottlieb said. One possible reason for under-enrollment of woman subjects may be of advanced age at disease onset, Gottlieb said, indicating sponsors should look into prevalence-adjusted representation of women in cardiovascular trials across relevant age categories. On the other end of the spectrum, sponsors are often hesitant to expose new or expectant mothers, who tend to be younger women, to experimental drugs, which can be a major barrier to developing drugs for conditions that are prevalent in younger women. To correct this, the FDA is using the Medication Exposure in Pregnancy Risk Evaluation Program to model pregnant women’s responses to drugs at reduced risk, he said. Other agency efforts to remedy gender parity issues include the agency’s Diverse Women in Clinical Trials Initiative consumer awareness campaign and a planned series of webinars on recruitment and retention of women in clinical trials. The agency is also conducting several research initiatives to aid in its regulatory decision-making with regard to sex differences, he said.