FDA Debars Two for Falsifying Clinical Trial Data

Posted 12 September 2012 | By Alexander Gaffney, RAC 

Federal regulators have debarred two researchers formerly employed by Kansas-based Lee Research Institute for falsifying data obtained from a clinical trial conducted on behalf of Schering-Plough, now a subsidiary of Merck & Co.

The researchers, Lisa Jean Sharp and Wayne Spencer, were both convicted in march 2012 of felony counts of failing to prepare and maintain records required under the Federal Food, Drug and Cosmetic Act (FD&C Act) with the intent to defraud and mislead investigators.

In July 2009, Schering-Plough contracted with Sharp and Spencer's employer, Lee Research Institute, to conduct research on an immunotherapy product it was developing. The study-a phase 2, interventional, randomized, double-blind, controlled safety assessment-was supposed to be conducted exclusively in patients over the age of 50, FDA said. Both Sharp and Spencer were charged with tracking data generated by the study and recording findings.

By January 2010, however, things were not going as planned. Sharp and Spencer worked to falsify the birth dates of two study participants to make them appear to be older than the requisite age of 50, had falsified additional exclusion criteria for the subjects, and further falsified records indicating they had been subject to a physical examination, recounted FDA in its Federal Register posting.

The duo's actions were later discovered in June 2012, at which time Lee Research Institute severed their employment ties to the company. They then turned over their findings to FDA, which later pursued legal actions against Sharp and Spencer.

In March 2012, both researchers pleaded guilty to charges of violating the FD&C Act in the US District Court of Kansas and were found guilty. The two were spared prison sentences, but were ordered to repay Lee Research the cost of the trial.

FDA said neither had taken it up on an opportunity to contest debarment proceedings brought by the agency against the two, and was thus moving to formally debar them from offering services to any company or person with an approved or pending drug product application.

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