After two Florida-based CRO study coordinators pled guilty to falsifying clinical trial data, the DOJ said Wednesday that those two have been sentenced to more than two years in prison each.
Falsifying clinical trial data and results is not a victimless crime. At one level, it is potentially fraud of a funding body or institution. On another, it can place future patients and the wider community at risk, because of a faulty understanding of a condition or the effectiveness/safety of an experimental intervention. It seems this US court agrees. An additional factor when someone considers falsification is that, if you believe in the promise of an intervention, if you cheat, you might sully the reputation of the intervention far into the future.
Tellus, which has worked with big-name pharma sponsors in the past like Pfizer, Gilead, Takeda, Boehringer Ingelheim and Eli Lilly, initially came under scrutiny for two trials related to opioid dependency, two for irritable bowel syndrome, and one for diabetes.
According to the indictment filed in March 2021, Diaz and Rico entered false information in the case histories of subjects to make it appear as if the subjects were eligible for a trial, or they recruited patients into trials who were not eligible, and obtained personally identifiable information from third parties to enroll patients without their knowledge or consent.
Three others affiliated with Tellus have previously pled guilty and are currently in prison after the scheme was uncovered.