Target Women’s Clinics, Keep Recruitment Open To Get More Women Into Trials, FDA Says In Guidance-thegraysheet: To get more women to participate in device clinical trials, companies should target women’s clinics for recruitment opportunities and plan focused efforts to enroll females under a continued access study. Those are two of multiple strategies FDA recommends in a final guidance (PDF) on parsing sex-specific clinical data. Adequate and appropriate populations of women are needed in clinical trials to support 510(k) clearances and PMAs, the agency notes.
