Would Medical Device Clinical Studies be Judged Gender-Biased if Sponsors Use Women-Focused Communication Strategies?

• By: Staff Editor
• Date: December 29, 2011

No. The FDA is trying to increase the representation of women in clinical studies of medical devices. According to the FDA’s recently issued draft guidance on Evaluation of Sex Differences in Medical Device Clinical Studies, medical device clinical trial sponsors can create tailored communication strategies (as used in the Women’s Health Initiative study) for study recruitment, informed consent documents and patient labeling.

The guidance also recommends that device manufacturers and developers, where appropriate, can target investigational sites where recruitment of women can be more easily facilitated. These investigational sites include women’s clinics.

Read an overview and summary of recommendations of the new FDA draft guidance aimed at increasing the representation of women in device clinical studies.