Women underrepresented in high-risk medical implant trials

Key takeaways:

• The median percentage of women randomly assigned in high-risk medical implant trials was 33%.
• CV trials had a significantly lower percentage of women included compared with other implant device trials.

Despite better representation in drug trials in the past few decades, women continue to be underrepresented in trials assessing high-risk medical implantation devices, according to a systematic review published in JAMA Internal Medicine.

“Women have been historically underrepresented in clinical research,” Nitzan Karny Epstein, MD, from the infectious diseases unit at Meir Hospital in Kfar Saba, Israel, and faculty of medicine at Tel Aviv University, Israel, and colleagues 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.”

Karny Epstein and colleagues identified 195 high-risk medical implant trials on PubMed, CENTRAL and Web of Science published from 2016 to May 2022. Researchers assessed representation rate by the number of women evaluated in each trial and assessed the participation-to-prevalence ratio for devices as the percentage of women participating in the general population.

Overall, the most common device categories were cardiovascular (67%) and orthopedic (20%). The percentage of women randomly assigned in each trial ranged from 7% to 100% with a median of 33%. Mean overall age of included women in most trials (90%) was older than 50 years.

CV trials included a significantly lower percentage of women (range, 23%-40%) compared with orthopedic trials (range, 33%-71%) and other trials (range, 33%-54%; P = .01). Stent trials included the lowest percentage of women (range, 23%-33%) while prosthesis trials had the highest percentages (range, 32%-74%; P = .01).

The participation-to-prevalence ratio was lower than 0.8 for stent, 0.76 for valve, 0.69 for orthopedic prosthesis, 0.56 for pump trials and 1 for pacemaker trials, the researchers wrote.

Researchers observed no association between the number of randomly assigned patients and the number of included women or trends over time in the percentage of women included by publication year and trial initiation year.

“Our review highlights underrepresentation of women in device trials across medical fields,” the researchers wrote. “Improved awareness and initiatives are essential to ensure adequate enrollment, considering potential gender-specific differences in medical device performance.”