Two data falsifiers sentenced to prison as FDA pledges to crack down on those undermining clinical trials
A federal judge on Wednesday sentenced two Florida-based clinical research site workers to more than two years of prison time each after they fabricated medical records to make it appear as though subjects were participating in clinical trials. And more prosecutions may be on the way as the FDA’s criminal investigations arm promises to haul in anyone else they find faking trial data.
The two sentenced — Eduardo Navarro, a nurse practitioner from Miami, to 46 months in prison, and Nayade Varona, an assistant study coordinator from Port St. Lucie, FL, to 30 months in prison — pled guilty in June and admitted to falsifying data in medical records from two clinical trials run by their company, called Tellus Clinical Research. The trials were intended to evaluate a drug for irritable bowel syndrome, although the US government database of clinical trials did not list either one.
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