Posted originally on TrialSite News by Staff on January 27, 2022

A project manager for Tellus Clinical Research, a Miami, Florida-based medical study firm, was sentenced to 30 months in federal prison with restitution fines of $2.1 million for falsifying clinical trial results.

Clinical Trials for Opioid Dependency, Irritable Bowl Syndrome Faked

United States District Judge Robert N. Scola Jr. of the Southern District of Florida found that Duniel Tejeda, 35, of Clewiston, Florida, committed conspiracy to falsify medical data associated with clinical research on opioid dependency, irritable bowel syndrome, and diabetic nephropathy. Tejeda’s misdeeds included inserting fake data from non-existent trial subjects.

Tellus Clinical Research has been under investigation for at least a year and ran studies since 2014.

“Clinical trials help ensure that new drugs are safe and effective for the public,” said Acting Assistant U.S. Attorney General Brian M. Boynton. “Falsifying clinical trial data undermines a critical component of the drug approval process.”Subscribe to the Trialsitenews “Clinical Trials” ChannelNo spam – we promise

Clinical Trial Scams Undermine Drug Safety, Place Public at Risk

Clinical trial fraud is a potentially lucrative scam with serious consequences for patients, contract research organizations, and clinical trial sponsors.

“Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review,” said Catherine A. Hermsen, an assistant commissioner for the FDA Office of Criminal Investigations. “We will continue to monitor, investigate and bring to justice those whose actions may subvert the FDA approval process and endanger the public health.”

Ghost Trial Participants, Fake Data

Instead of honestly recruiting patients with the diagnoses needed to participate in Tellus’ clinical trial program, Tejeda and other defendants enrolled people without applicable diagnoses and falsely claimed to have fulfilled study protocol and demanded payments from the clinical trial sponsors. 

Defendants enrolled friends and family members to fake participation numbers. Clinical notes and medical records were also faked.