Researcher Sentenced To Probation For Falsifying Clinical Drug Trial
TOPEKA, KAN. – A clinical research coordinator who pleaded guilty to falsifying data in a clinical drug trial has been sentenced to probation and ordered to pay restitution, U.S. Attorney Barry Grissom said today.
Lisa Sharp, 49, Olathe, Kan., was sentenced to one year on supervised release and ordered to pay restitution of more than $36,000. She pleaded guilty to one count of conspiracy and one count of failing to maintain records in a clinical trial. The sentence was the same as her co-defendant Dr. Wayne Spencer received at a hearing earlier this month.
In their pleas, Sharp and Spencer admitted falsifying the results of a clinical drug trail they were paid to perform while they worked for Lee Research Institute. Lee Research Institute was hired by Schering/Plough, a pharmaceutical company, to perform clinical drug trials on a tablet developed for treating allergies. Spencer was the principal investigator for the clinical study and Sharp was the director of clinical trials for Lee Research Institute.
Schering/Plough’s plans for the study called for all test subjects to be 50 years of age or older and to suffer from ragweed-induced allergy symptoms. Schering/Plough required that employees of the clinical trial facility be excluded as test subjects.
Sharp and Spencer reported that eight test subjects were qualified, even though they knew two of the subjects were not qualified. The two subjects were employees at Lee Research Institute, who were using false names and dates of birth to participate in the study. Both were under 50.
Spencer signed multiple documents for the enrolled employees, including forms falsely indicating he had performed physical examinations on the two. Sharp signed multiple documents for the two employees, including documents that falsely stated their dates of birth. She also arranged for the two to have office visits when the Executive Director was at lunch in order to conceal from her that the two employees were participating in the study. As a result of the fraud, Schering/Plough issued checks totaling more than $30,000 to Lee Research Institute in payment for the clinical study.
Grissom commended the Food and Drug Administration and Assistant U.S. Attorney Tanya Treadway for their work on the case.