FDAnews Drug Daily Bulletin

Sponsors May Need to Redo Studies Affected by Disputed Cetero Data

May 24, 2012
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Some drug-trial sponsors who used the discredited CRO Cetero Research will need to reanalyze or repeat studies, while others will need to conduct an independent third-party data audit, the FDA told drugmakers in late April. Some luckier sponsors will get a free pass. Sponsors were first notified that work might need to be repeated in July, when the agency revealed that the now infamous CRO violated federal regulations, including falsifying documents and manipulating samples in a number of studies conducted between April 2005 and June 2010. The transgressions threw into question the validity of all of Cetero’s work during that period.
Clinical Trials Advisor