Pharma

FDA says CRO Cetero faked trial data; pharmas may need to redo tests

North Carolina clinical research organization Cetero Research allegedly falsified clinical trial documents and test results […]

North Carolina clinical research organization Cetero Research allegedly falsified clinical trial documents and test results over a five-year period, and now an undetermined number of drug companies who worked with the CRO must review their records to determine whether new tests on their drugs are required.

In a July 26 letter to Cetero, the U.S. Food and Drug Administration describes the falsification as “extensive,” calling into question all bioanalytical data collected by Cetero’s Houston bioanalytical laboratory from April 1, 2005 to June 15, 2010. The FDA said Cetero manipulated test samples so the tests would yield desired results. The FDA did not identify any of the drugs or sponsoring drug companies whose data was affected.

Just how much data was falsified is still unknown. Although Cetero conducted its own internal investigation, the FDA determined that Cetero’s inquiry was insufficient. Cetero has 15 days to respond with a list of all tests related to FDA research done at the Houston site in the specified five-year period so the agency can determine how many drug applications were affected.

The FDA said there is no evidence that already marketed drugs pose a safety risk. But the agency is asking drug companies to review work Cetero did for them to ensure that test results are reliable. That could get expensive. Companies whose drugs were approved with Cetero’s faked test results might have to pay for a whole new slate of clinical studies.

Cary, North Carolina-based Cetero issued a prepared response late Wednesday afternoon. The company said that it initiated its own internal investigation and proactively contacted the FDA to self-report its findings. Cetero said it contacted some clients as well to notify them of the situation. Cetero said that the FDA letter does not accept the company’s “rigorous scientific analysis” and discredits the company.

“The research conducted on behalf of our pharmaceutical sponsors can be, and has been, properly validated,” Cetero said.

Privately held Cetero describes itself as an early phase CRO and claims to complete more than 750 early phase clinical studies annually.  The company says it has conducted more than 20,000 total pharmacology studies in its history. The FDA acknowledges that Cetero started its own internal investigation. But the agency says that 2009 investigation came only after a Cetero employee submitted to the company a letter bringing formal allegations of regulatory violations and misconduct. According to the FDA, the employee said “many of the chemists were manipulating and falsifying data associated with the samples being used within various projects.”

Cetero enlisted a third-party firm to conduct an independent investigation. The FDA conducted two of its own inspections last year in May and December. In Cetero’s Wednesday response, the company said its inquiry found problems only with six chemists who misreported the date that samples were extracted before they were analyzed. Cetero’s explanation is that the chemists were seeking more money by claiming hours when they did not actually work.

The FDA suggests broader misconduct. The agency notes that Cetero’s own internal investigation found time and date discrepancies that showed a mismatch of when Cetero lab staff was working and when test samples were studied. In at least 875 instances, lab chemists weren’t even at the facility when test samples were extracted. While Cetero attributed the false claims of weekend and holiday work to workers trying to claim overtime, the FDA noted that the reasoning doesn’t explain the falsification of weekday work records. In addition to the inconsistent time and date records, the FDA found that Cetero falsified data from multiple studies for multiple clinical trial sponsors. Cetero agreed with that observation in its May 24, 2010 response letter to the FDA. The FDA said the fabrications cast doubt on the reliability of the remaining lab records.

Cetero said that it has been “transparent and forthcoming” with the FDA inquiry, but over the course of the 18-month investigation, the agency told the company nothing until the July 26 letter. The company said that processes in use today are in full compliance with FDA and industry standards. Cetero has seven sites in North America. The FDA names only the Houston laboratory as a site where data was falsified. Incidentally, Cetero’s most recent press release was the April announcement of a new executive hire: Pharmaceutical industry veteran James Dixon was named Cetero’s senior vice president, quality and compliance.

“Quality, safety and consistency are more important than ever in our industry,” Dixon is quoted as saying in the release. “I am committed to building upon Cetero’s reputation as the leader in early stage clinical research and to further improving on our record of high-quality performance and reliability.”

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