A federal judge sentenced two Florida clinical research workers to prison in connection with their participation in a conspiracy to falsify data related to clinical drug trials.
U.S. District Judge Jose E. Martinez sentenced Eduardo Navarro — a nurse practitioner and sub-investigator at Tellus Clinical Research — to 46 months in prison and Nayade Varona — an assistant study coordinator at Tellus— to 30 months in prison. The court also ordered the defendants to pay $2,134,503 in restitution.
The two defendants admitted that they conspired with others to falsify data in connection with two clinical trials by, among other things, fabricating medical records to make it appear as though subjects were participating in the clinical trials when they were not.
Both the Justice Department and the FDA warned that they will continue to investigate and prosecute anyone who undermines the clinical trial process.
“The agency will aggressively pursue violations that threaten the integrity of clinical trial data in order to protect the public’s access to safe and effective products,” said Assistant Commissioner for Criminal Investigations Catherine Hermsen of the FDA.
