A systematic review of 123 studies for 78 FDA-approved high-risk cardiovascular devices revealed that 28% did not report enrollee sex, and studies reporting sex averaged only 33% women.
Systematic Review (n=123)
There is a significant lack of sex-specific safety and effectiveness data for high-risk cardiovascular devices prior to FDA approval, with women being consistently underrepresented in clinical trials.
BACKGROUND: Cardiovascular devices can have different safety and effectiveness profiles in men and women. The type and quality of sex-specific data reviewed by the Food and Drug Administration (FDA) before approval of these devices are unknown. METHODS AND RESULTS: We performed a systematic review of the demographics, comments on gender bias, and analysis of results by sex for 78 high-risk cardiovascular devices that received premarket approval by the FDA between 2000 and 2007. FDA summaries of evidence did not report sex of enrollees in 34 (28%) of 123 studies. For studies reporting sex distribution, the study populations were, on average, 67% men. There was no increase in the enrollment of women over time. Explanations for the relatively low percentage of women often stated that the trials reflected either underlying disease distribution or referral rates for similar procedures or that the sex distribution reflected similar or previous trials. Forty-one percent of studies included a gender bias comment or analysis, and 12 (26%) of 47 of these analyses identified some difference in device safety or effectiveness by sex. CONCLUSIONS: There is a lack of sex-specific safety and effectiveness data for high-risk cardiovascular devices before FDA approval. The justifications for this lack of evidence may perpetuate the status quo. More rigorous FDA requirements for sex-specific data before device approval could present an opportunity to improve cardiovascular outcomes.
Dhruva et al. (Tue,) conducted a systematic review in High-risk cardiovascular devices (n=123). High-risk cardiovascular devices was evaluated on Demographics, comments on gender bias, and analysis of results by sex. A systematic review of 123 studies for 78 FDA-approved high-risk cardiovascular devices revealed that 28% did not report enrollee sex, and studies reporting sex averaged only 33% women.