Women Still Underrepresented in Medical Device Clinical Trials

A recent systematic review published in JAMA Internal Medicine underscored the ongoing underrepresentation of women in medical device clinical trials. In a review of 195 trials which were majority conducted between 2013 and 2022, study researchers uncovered that only about one-third of participants evaluating medical devices were women. Additionally, they found that the percentage of women included as participants in studies over the decades have not increased over time.

“Women have been historically underrepresented in clinical research,” the study wrote. “When underrepresented in device trials, data on performance of devices in women may be lacking as it is influenced by sex-related covariates, such as body size, hormonal variations, comorbidities, and parity.”

The worst offenders, according to the study, were trials testing cardiovascular devices like stents and pumps, where women only made up 29% of the reviewed trials. Comparatively, studies testing orthopedic, neurological, pulmonary, and other tools had closer to half of its participants reported to be female.

Authors of an associated commentary also published in JAMA Internal Medicine wrote that one way to improve equitable gender representation in medical device trials was to have FDA increase its efforts to implement the guidelines it has issued over the last two decades. This effort could include denying study applications that don’t include adequate representation margins. “Clinical trials must be representative of the population in whom the device will be used because we know that risks and benefits differ by age, gender, and other characteristics,” the study wrote.

“The time has come for the FDA to decline to review medical device (and drug) applications if the representation of women does not reflect the intended use population within a reasonable margin,” according to the authors.