CRO Employees Plead Guilty To Falsifying Data

CRO Employees Plead Guilty To Falsifying Data

October 20th, 2011 // 2:58 pm @

A doctor and a clinical research coordinator who worked for a contract research organization hired by the former Schering-Plough have pleaded guilty to conspiring to defraud the drugmaker by falsifying study data. They also pleaded guilty to failing to maintain records as required by the FDA. The clinical trial, by the way, was designed to test a tablet the drugmaker was developing to treat allergies.

The pleas were made by Wayne Spencer, a 73-year-old doctor from Topeka, Kansas, and Lisa Sharp, 48, a registered nurse from nearby Olathe, who was the director of clinical trials for the Lee Research Institute. They could face up to five years in prison and fines up to $250,000 each for the conspiracy charge, and up to three years and a $10,000 fine for failing to maintain records in a clinical trial. Sentencing is scheduled for January, although prosecutors recommended probation (here is the Spencer plea agreement).

As reported previously, the study was to have enrolled patients at least 50 years old who suffer from ragweed-induced allergy symptoms. Employees at the CRO, which is based in Lenexa, Kansas, were not supposed to participate, but two subjects were Lee Research employees and both were younger than 50. And Sharp and Spencer reported all eight of their subjects were qualified, even though false names and birth dates were provided.

The trial took place last year and the feds alleged the pair provided false info about the patients; falsely stated physical exams had been conducted on the two unqualified subjects and signed false statements to the FDA indicating the trial was being conducted in accordance with proper protocol. Schering-Plough, which is now owned by Merck, paid Lee Research more than $30,000 for its work.

Source: Pharmalot


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