Violation Rate Increases for Clinical Trials

The violation rate for clinical trial sponsors went up in fiscal year 2007, hitting a 10-year high, and the U.S. Food and Drug Administration found many of the problems during inspections to be triggered by complaints, said the Center for Devices and Radiological Health. 

Of the 40 trial sponsors inspected by the device center’s division of bioresearch monitoring (BIMO), 33 percent were found to have significant regulatory violations. That compares with 11 percent of the 53 sponsors inspected in fiscal year 2006 that were significantly out of compliance, which was the best industry performance in 10 years. 

Device companies received eight warning letters in 2007, which is five more than in 2006. 

The BIMO division is responsible for checking on the quality and integrity of clinical trial data and ensuring that trial subjects are protected from hazards and risks. 

Of 323 BIMO inspections in fiscal year 2007, 14 percent were tagged, up from 11 percent the year before. Twenty-nine resulted in warning letters, up from 24.

For more information on preparing for BIMO inspections, visit http://www.mpo-mag.com/articles/2008/11/preparing-for-fda-bimo-inspections.