Study coordinator pleads guilty to trial data falsification
Duniel Tejeda, a former project manager and study coordinator with Tellus Clinical Research in Miami, has entered a guilty plea in response to charges that he was part of a conspiracy intended to falsify data in a number of clinical trials.
As part of his plea agreement, Tejeda (who faces a maximum sentence of 20 years) conceded to working with others on falsification of medical records in trials involving a range of conditions, including opioid dependency, irritable bowel syndrome, and diabetic nephropathy. The offenses Tejeda admitted to included falsifying data to make it appear as though patients had been participating in the studies when they actually were not subjects in the trials at all.
Acting assistant attorney general Brian Boynton, with the Justice Department’s Civil Division, said, “The defendant’s conduct put profits before public health. 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.”
“The public relies on the accuracy and honesty of clinical trial data,” said US attorney Juan Antonio Gonzalez for the Southern District of Florida. “Falsifying clinical data not only violates the public’s trust, but it also endangers the safety of consumers; those who unlawfully profit by compromising the public’s health in this way commit serious crimes and will be prosecuted.”
Assistant commissioner for criminal investigations Catherine Hermsen of the US Food and Drug Administration's (FDA) Office of Criminal Investigations, said the agency’s evaluation of the fitness of new therapies depends upon accurate, reliable clinical trial data.
“Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review,” she said. “We will continue to monitor, investigate and bring to justice those whose actions may subvert the FDA approval process and endanger the public health.”
The court scheduled a sentencing hearing for January 20, 2022. A federal district court judge will determine any sentence after considering the US Sentencing Guidelines and other statutory factors.
The FDA's Office of Criminal Investigations is investigating the case. Trial attorneys Lauren Elfner and Joshua Rothman of the Justice Department’s Consumer Protection Branch are the prosecutors of record.