The conduct of clinical trials: a Food and Drug Agency perspective.
The conduct of a clinical trial required by FDA regulations should be executed in conformity with a protocol developed as a cooperative endeavor involving the Agency, the sponsor requiring device approval for marketing, and the investigators. This is the process most likely to assure a scientifically satisfactory study design that will address the primary concerns of all the parties. More importantly, timely access to safe and effective technologic advances will be made available to the health provider community based on the best scientific evidence.
Sapirstein
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Division of Cardiovascular and Respiratory Devices, Center for Devices and Radiological Health, FDA, Rockville, Maryland 20878, USA.
D002986:Clinical Trials as Topic; D004864:Equipment and Supplies; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration