Clinical Researchers Plead Guilty in Connection with Scheme to Falsify Drug Trial Data

On 8 June 2021 the US Department of Justice released update on clinical researchers’ clinical trial data scheme.

A Florida nurse practitioner and a Florida woman pleaded guilty to their participation in a conspiracy to falsify clinical trial data.

According to court documents, Eduardo Navarro, 52, of Miami, and Nayade Varona, 50, of Port St. Lucie, worked at a clinical research site called Tellus Clinical Research. Navarro was a sub-investigator, and Varona was an assistant study coordinator. As part of their plea agreements, Navarro and Varona admitted that they agreed with one another and others to falsify data in medical records in connection with two clinical trials intended to evaluate a treatment for irritable bowel syndrome. Among other things, Navarro and Varona falsified data to make it appear as though subjects were participating in the trials when, in truth, they were not.

Navarro and Varona both pleaded guilty before U.S. District Judge Jose E. Martinez of the Southern District of Florida to conspiracy to defraud the United States and to commit an offense against the United States. Both face a maximum penalty of five years in prison and are scheduled to be sentenced on Aug. 11. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.

The FDA's Office of Criminal Investigations is investigating the case.

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