Extensive data falsification at a clinical research site in Florida has led to a number of research coordinators receiving prison sentences in recent months.
In July, Analay Rico of Fort Lauderdale and Daylen Diaz of Miami who both worked at Tellus Clinical Research, Miami, admitted that they had defrauded clients paying for work evaluating treatments of opioid dependency, irritable bowel syndrome and diabetic nephropathy treatments. Under plea agreements, Rico and Diaz admitted – among other things – to falsifying data from fictional trial participants, according to the Department of Justice.
Three other Tellus employees also admitted to taking part in the data falsification scheme, creating the impression that certain trials had active participants and were handed prison sentences ranging from 30 to 46 months and orders to pay in the region of $4.2 million in restitution.
The trial of a further three participants was due to commence in late September.
“The public relies on the accuracy of clinical trial data,” said Florida US Attorney Juan Antonio Gonzalez. “Falsifying clinical data endangers the safety of consumers and violates the public’s trust. It is a serious crime that we will continue to vigorously prosecute.”
The FDA’s criminal enforcement arm – OCI – is investigating the case.
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