The Food and Drug Administration (FDA) announced on Tuesday that a
drug research firm faked documents and manipulated samples during clinical research trials performed by the company.
The FDA discovered the misconduct by Cetero Research, based in Cary,
North Carolina, during two 2010 inspections at the company's
Drug manufacturers hire firms like Cetero to conduct research on new drugs and then use the results to support drug approval applications with the FDA.
Cetero's "pattern of misconduct was serious enough" to bring all of the company's research results in question, the FDA said.
All drug companies that contracted Cetero Research to conduct drug tests between April 2005 and June 2010 will likely have to reevaluate the results of those tests.
During inspections in May and December of last year, the FDA uncovered at least 1,900 instances of falsified records in Cetero's studies, including listing lab technicians as having conducted studies who were not actually present at the trials; manipulating studies to achieve a desired result; and failing to include failed results in their research reports.
The drug manufacturers who contracted Cetero Research to conduct studies within the 2005-2010 timeframe have not yet been identified.
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