Sex, age and race don't feature enough in medical device evaluation

Researchers in the US report that too few medical device manufacturers factor in the influence of their users' sex, age, or race on safety and effectiveness.

The research was conducted by teams at Yale and the University of California-San Francisco and published in JAMA Internal Medicine.

"We know that women, the elderly, and minorities have been underrepresented in clinical trials for drugs and treatments of many diseases and conditions," said lead author Sanket S. Dhruva, M.D., a postdoctoral fellow at Yale School of Medicine.

"Our new study shows how these important patient groups are also being overlooked in the evaluation of medical devices."

Of 82 studies filed in 2015 with the FDA in support of premarket approval for original medical devices, only nine percent were analysed by age and four percent by race. Only 17 percent of the 77 studies that included both men and women analysed gender.

The studies were all conducted after the FDA’s call in 2014 for examination of results by age, race, and/or ethnicity.

"Moreover, 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."