Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?

Abstract

Policy Points: A 1993 law required the National Institutes of Health to include women and racial and ethnic minorities in relevant research studies. Most federal health agencies adopted the same policy, but the US Food and Drug Administration (FDA) did not. A 2012 law encouraged the FDA to ensure that new medical products be analyzed for safety and effectiveness for key demographic patient groups. Our study of high-risk medical devices reviewed by the FDA in 2014-2017 found that due to lack of p