Women Still Underrepresented in Medical Device Clinical Trials

A recent systematic review underscores the continued underrepresentation of women in medtech studies, having only one-third overall participation rates.

Katie Hobbins, Managing Editor

July 8, 2024

1 Min Read
Clinical trial
macniak / iStock / Getty Images Plus via Getty Images

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.

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like