DEVICE CLINICAL STUDIES SHOULD BE "OVERDESIGNED"
This article was originally published in The Gray Sheet
Executive Summary
DEVICE CLINICAL STUDIES SHOULD BE "OVERDESIGNED" to account for the likelihood that some data will be invalidated, Richard Chiacchierini, director of the Division of Biometric Sciences in FDA's Center for Devices and Radiological Health, said, at an FDA/industry teleconference on clinical trials Jan. 27. "Very many medical device manufacturers will design a study on the margin of adequacy," Chiacchierini remarked. "If you have a marginally designed study and something goes wrong, you've probably wasted everything." The teleconference was cosponsored by CDRH and the Food and Drug Law Institute.