Life Sciences Intelligence June 12, 2024
Veronica Salib

A research letter published in JAMA Internal Medicine found that medical device clinical trials had a median female participant rate of 33%.

Earlier this week, a research letter published in JAMA Internal Medicine evaluating female representation in randomized clinical trials for FDA-supervised medical devices found that women are generally underrepresented in these studies. The findings suggest that the guidance for female inclusion in medical device trials needs improvement.

The article was a systematic review of high-risk medical implant clinical trials from January 2016 to May 2022, focusing on gender representation across the trials. To calculate female representation, the researchers divided the number of women randomized by the total number of participants randomized. For trials that did not include that information,...

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Topics: Clinical Trials, FDA, Govt Agencies, Medical Devices, Patient / Consumer, Provider, Trends
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