Federal prosecutors are alleging that two people formerly with a CRO in Kansas falsified data in an early-stage study done on behalf of Schering-Plough (which merged with Merck in 2009), the Kansas City Business Journal reports.
Physician Wayne Spencer and Lisa Sharp face potential jail sentences and hefty fines for their alleged parts in hiding the fact that study subjects in a trial for an allergy pill weren't qualified to participate, among other allegations, the newspaper reports. Schering had contracted Lee Research Institute in Lenexa, KS, to conduct the study during the first half of last year. The CRO itself has not been indicted in the case.
Lee Research said in a statement that Spencer and Sharp were let go after the alleged misconduct came to its attention last June. Spencer was the principal investigator on the study and Sharp was director of clinical trials at the company.