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Animal Ethics Biosafety Human Research Ethics Research Integrity

(US) Clinical Researchers Sentenced in Connection with Scheme to Falsify Drug Trial Data – The Office of the Attorney General blog (August 2021)

Posted by Dr Gary Allen in Research Integrity on November 27, 2021
Keywords: Clinical trial, Data management, Institutional responsibilities, International, Medical research, Research integrity, Research Misconduct

The Linked Original Item was Posted On November 11, 2021

A women's hand in jail, gripped on bars from inside a cell

A federal judge sentenced a Florida nurse practitioner and a Florida woman to prison terms today in connection with their participation in a conspiracy to falsify data related to clinical drug trials.

A shocking Research Misconduct/data falsification in clinical trials story from the US.  The prison term and restitution fine handed down by the court reflects the consequences of corrupting the body of evidence that is used to determine if a medical treatment is efficacious and safe.

U.S. District Judge Jose E. Martinez of the Southern District of Florida sentenced Eduardo Navarro, 52, of Miami, to 46 months in prison, and Nayade Varona, 50, of Port St. Lucie, to 30 months in prison. The court also ordered the defendants to pay $2,134,503 in restitution. According to court documents, Navarro and Varona worked at a clinical research site called Tellus Clinical Research (Tellus). Navarro, a nurse practitioner, was a sub-investigator at Tellus, and Varona was an assistant study coordinator. As part of their plea agreements, Navarro and Varona 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, in truth, they were not.

“By falsifying clinical trial data, the defendants undermined a crucial component of the drug approval process,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The Justice Department will continue to work with its partners at the Food and Drug Administration to investigate and prosecute anyone who engages in this conduct.”

Clinical Researchers Sentenced in Connection with Scheme to Falsify Drug Trial Data
A federal judge sentenced a Florida nurse practitioner and a Florida woman to prison terms today in connection with their participation in a conspiracy to falsify data related to clinical drug trials.

Related Reading

(US) Miami doctor pleads guilty to falsifying clinical trial data for asthma medication – Miami Herald (Jay Weaver | January 2021)

Continued post-retraction citation of a fraudulent clinical trial report, 11 years after it was retracted for falsifying data (Papers: Jodi Schneider, et al | October 2020)

(Taiwan) Researcher formerly of OSU and Taiwan’s Academia Sinica gets 10-year ban – Retraction Watch (Adam Marcus | February 2020)

How Universities Cover Up Scientific Fraud – Areo (Justin T Pickett | February 2020)

Fraud In A Leading UK Scientist’s Lab – BuzzFeed News (Peter Aldhous | July 2019)

(US) Mount Sinai multiple sclerosis researcher admits to misconduct – Retraction Watch (Ivan Oransky | May 2018)

Why do researchers commit misconduct? A new preprint offers some clues – Retraction Watch (Ivan Oransky | April 2017)

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