Patients Need Voice in Trials for New Medical Products, FDA Says

Patients who use medical devices should have a say in designing the clinical trials that determine which products make it to the market, the FDA said.

Draft guidance issued Sept. 23 from the Food and Drug Administration provides recommendations on how device manufacturers can work with patients to design the clinical studies that test their products for safety and effectiveness. The agency wants the clinical researchers to use patient advisers who will provide input on how to make the study work better for those who will ultimately use the device. Advisers shouldn’t enroll in the same study for which they’re ...