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Sex-specific data available before approval of high-risk CV devices lacking
Dhruva S. Circ Cardiovasc Qual Outcomes. 2011;4:165-171.
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Women are under-represented in terms of safety and effectiveness data in trials for CV devices reviewed for approval by the FDA, according to new study results.
Researchers examined enrollment data on sex in 123 studies from 78 premarket approvals (PMAs) for high-risk CV devices from 2000 to 2007. The study was limited to approved PMAs because, the researchers wrote, “the FDA does not make available Summaries of Safety and Effectiveness Data (SSEDs) for devices that were not approved.”
According to the results, the sex of enrollees was not reported in 24 (38%) of the FDA SSEDs. Fifty-one of the 123 studies had a gender bias comment or analysis, and about one-quarter of those studies (12 of 47) included some difference in device safety or effectiveness based on sex. No increase in the enrollment of women was reported. Mean age was a predictor of sex, with each 10-year increase in mean age correlating with a 5% decrease in the enrollment percentage of women (P<.0005). In 29% (36 of 123) of the studies that contained statements regarding study sex proportions, the disparity was attributed to a “reflection of the disease distribution or referral for that or similar procedures.” In eight (7%) of the studies, the low proportion of women was justified as being “similar to that of other trials.”
The researchers said some federal agencies have made efforts at requiring more accurate and complete reporting of sex-specific data in clinical trials. They cited several FDA meetings in 2008 held to plan for a guidance document aimed at helping incorporate more sex-specific data in all device trials reviewed by FDA, as well as pending legislation in Congress (the Heart Disease Education, Analysis Research, and Treatment for Women Act) that would mandate sex-specific data reporting, as examples of initiatives being undertaken to correct the problem.
“The lack of sex-specific data before device approval may lead to delays in discovery of safety and efficacy concerns,” the researchers wrote in the study. “These multipronged efforts all will help to increase enrollment of women and the reporting of sex-specific data to ensure that we can optimize risk/benefit in treatment choices for all patients.”
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