FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Most Device Trials Still Ignore Age, Sex, Race

July 27, 2017

Medical device trials continue to overlook the potential effects of race, sex and age on the device’s safety and effectiveness, according to a new study.

The research, conducted by analysts from Yale and the University of California-San Francisco, found that of 82 studies filed in 2015, only 9 percent were analyzed by age and 4 percent by race. Of 77 featuring men and women, only 17 percent were analyzed by sex.

Thirteen of the 82 trials were analyzed by sex, with one finding the device was less safe for men, one finding the device was less safe for women and one finding the device was less effective for women. Only seven studies analyzed results by age, three of which found performance differences by age group.

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