More Clinical Trials are Out of Compliance

Medical Product Outsourcing reports that the violation rate for clinical trial sponsors have gone up for the fiscal year of 2007, which has hit a 10 year high says the U.S. Food and Drug Administration.

Thirty three percent of the 40 clinical trial sponsors inspected by the center’s division of bioresearch monitoring were found to have some sort of regulatory violation, as opposed to 11 percent of 53 sponsors who were out of compliance the previous year. 2006 proved to be the best performance the industry had seen in 10 years. Can we expect 2008 numbers to produce similar results?