Study finds insufficient enrollment of women in medical device trials

A recent study published in JAMA Internal Medicine reveals that women continue to be underrepresented in medical device trials, particularly in cardiovascular studies. The research found that from 2010 to 2020, the percentage of women participating in high-risk medical device trials did not increase, with women making up just 33% of participants in trials published from 2016 to 2022. The discrepancy in representation varied between devices, with women making up 46% of participants in orthopedic trials but only 29% in cardiovascular studies.
This issue is not new, as historically, women have been excluded from medical research, such as the FDA advising researchers in 1977 to exclude women of reproductive potential from early clinical trials. While there have been some strides in correcting past mistakes, stakeholders believe that more can be done to incentivize the enrollment of women in medical device trials. There is a call for agencies like the FDA to take further action to ensure better representation of women in research.
Overall, the study highlights the ongoing challenge of gender disparities in medical research, particularly in the context of clinical trials for cardiovascular devices. The underrepresentation of women in these trials raises concerns about the generalizability and effectiveness of these devices for female patients. Moving forward, efforts to address this issue are needed to ensure that medical research is inclusive and reflective of the diverse population it serves.