Gottlieb Calls on Clinical Trial Operators to Find Ways to Enroll More Women

Clinical trial sponsors must step up their efforts to address underrepresentation of women among trial subjects, said FDA Commissioner Scott Gottlieb 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.