STAT+: Medical device trials still don’t enroll enough women, study finds

Women have always been underrepresented in medical research. A new study reveals that not much has changed, especially when it comes to tests of cardiovascular devices. 

In a paper published in JAMA Internal Medicine on Thursday, researchers found that the percentage of women represented in high-risk medical device trials has not increased from 2010 to 2020. Women generally made up just 33% of participants when the team reviewed 195 trials published from 2016 to 2022. The percentages varied between devices: Women made up 46% in orthopedic trials, but 29% in cardiovascular. 

The issue isn’t new. The government has made some strides in correcting earlier missteps, like the Food and Drug Administration telling researchers in 1977 to exclude women of reproductive potential from early clinical trials. But stakeholders think agencies like the FDA could do more to incentivize enrollment of women.

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