Despite FDA guidelines, very few medical device trials are analyzed to consider how a user’s sex, age or race could affect safety and effectiveness of the device, according to a new study out of Yale and the University of California-San Francisco.
Results from the study were published in Jama Internal Medicine.
The study aimed to examine how often age, sex and race were taken into account during FDA-clearance seeking medical device testing following a 2014 FDA Action Plan which aimed to address the issue that certain groups were significantly underrepresented in clinical trials.
Researchers examined 82 studies filed in 2015 with the FDA from companies seeking premarket approval for their devices, and found that of the studies, only 9% were analyzed by age and only 4% by race. Of 77 studies which included both men and women, only 17% were analyzed by sex, according to a Yale report.
“We know that women, the elderly and minorities have been underrepresented in clinical trial for drugs and treatments of many diseases and conditions. Our new study shows how these important patient groups are also being overlooked in the evaluation of medical devices,” lead author Dr. Sanket Dhruva of Yale School of Medicine said.
A total 13 of the 82 trials included in the study were analyzed by sex – 1 found less safety for their device in men, 1 found less safety in women and 1 found less effectiveness in women, according to the study.
Of the 7 studies that analyzed results by age, 3 of them found what would otherwise have been unknown performance differences for older or younger patients. Of the 3 analyzed for race, a single trial found the device less effective in non-white patients, according to the study.
Study participant age and sex were only reported approximately 66% of the time in the trials, while age and race were only included in approximately half of the studies.
“Moreover, when such data were reported, we often could not determine if statistical tests or analyses were employed. This makes it difficult to evaluate the clinical significance of the findings,” Dhruva said, according to a Yale report.
Study authors suggested that possible changes to the Medical Device User Fee Amendments could be enacted to require clinical trials enroll women, minorities and the elderly in proportions used by the device’s target population.
