CHICAGO – Few medical device trials consider the user’s sex, age or race when it comes to safety and effectiveness, according to a study published recently in JAMA Internal Medicine.
“Our new study shows how these important patient groups are also being overlooked in the evaluation of medical devices,” said Dr. Sanket Dhruva, one of the study’s researchers, in the published report.
Researchers at Yale and the University of California-San Francisco examined 82 studies filed in 2015 with the U.S. Food and Drug Administration in support of premarket approval for original medical devices. They found that only 9% were analyzed by age and 4% by race. Of the 77 studies that included both men and women, only 17% were analyzed by sex.
The researchers also found infrequent analyses despite an action plan implemented by the FDA in 2014 calling for examination of results by age, race and/or ethnicity.
“When such data were reported, we often could not determine if statistical tests or analyses were employed,” Dhruva said. “This makes it difficult to evaluate the clinical significance of the findings.”
The age and sex of study participants were reported in only about two-thirds of all studies supporting agency premarket approval for medical devices in 2015. Race and/or ethnicity was reported in about half.