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www.fdanews.com/articles/132492-fda-denies-8216-training-patients-8217-slip-through-device-approvals

FDA Denies ‘Training Patients’ Slip Through Device Approvals

December 7, 2010
The FDA is denying claims that it does not consider results from “training patients” in clinical trials when approving cardiac devices. Training patients are the first individuals in whom a physician uses an investigational device. Such subjects “comprise a considerable proportion of patients receiving investigational cardiovascular devices, but their results are excluded from FDA submissions,” according to a new Archives of Internal Medicine report. “Their exclusion from analyses means that safety and efficacy outcomes may look better than actual results,” the report adds.
Devices & Diagnostics