Warnings for Clinical Trials Show Four-Year Uptrend

CDER’s Division of Scientific Investigations (DSI) has been sending out an increasing number of warning letters on the conduct of clinical trials over the past four years. The number of letters more than doubled from 10 in fiscal 2006 to 22 from last Oct. 1 through Aug. 21, according to figures provided by DSI Director Leslie Ball. The majority of warning letters in the four-year span went to clinical investigators — from five in fiscal 2006 to 18 so far this fiscal year.
Clinical Trials Advisor