Approval of Medical Device Changes Often Based On Low-Quality Research, UCSF and Yale University School Of Medicine Study

Clinical trials that test changes in the design or use of high-risk medical devices are often poorly designed, and can rely on inadequate or potentially biased data, according to a new study by researchers at the UC San Francisco and Yale School of Medicine.

In the study, published August 15, 2017, in JAMA, the authors reviewed clinical trials supporting U.S. Food and Drug Administration (FDA) approval of changes to high-risk devices over the last decade. They found that fewer than half of these studies were randomized, blinded, or controlled – the “gold standards” for clinical trials of drugs.

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