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 Monday, researchers found that the percentage of women represented in high-risk medical device trials did not increase 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% of participants in orthopedic trials, but 29% in cardiovascular studies. 

advertisement

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 the enrollment of women.

STAT+ Exclusive Story

STAT+

This article is exclusive to STAT+ subscribers

Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+.

Already have an account? Log in

Already have an account? Log in

View All Plans

Get unlimited access to award-winning journalism and exclusive events.

Subscribe