FDA Issued Permanent Debarment for Falsifying and Fabricating Clinical Trial Data

07/11/2023

In June 2023, the U.S. Food and Drug Administration (FDA) issued a permanent debarment as required under the FD&C Act due to the grounds that the individual was convicted of a felony. The individual worked as a coordinator at a clinical site on studies over a variety of therapeutic areas. Their delegated tasks included administering procedures and maintaining case histories of the study participants.

The coordinator fabricated and falsified case histories to make it appear that there were participants who met eligibility criteria, gave informed consent, received the investigational product (IP), completed study visits, and received payments. The study participants were actually 1) co-conspirators who did not meet inclusion/exclusion criteria for enrollment and did not receive any IP or were 2) individuals who the coordinator and their co-conspirators either fabricated or enrolled in the study records without the individual’s knowledge, and the co-conspirators provided fabricated information to the eDiary system about their experience with the IP. More than one clinical trial at the site was impacted.

The FDA was notified about the suspicion of fabricated and fraudulent data at the site and conducted an inspection. The coordinator contacted individuals to lie to the field investigators about their involvement in the clinical trials. The felony conviction is related to the conspiracy to falsify clinical trial data.

Falsifying study data is not only illegal, but it also provides an inaccurate assessment of the safety and efficacy of the investigational product. Accurate and high quality data are necessary for the sponsor to decide whether to move forward with additional clinical trials or for the FDA to approve an investigational product. Inaccurate data could needlessly harm consumers who use the drug, biologic, or device without an adequate safety profile and inaccurate labeling. Site staff falsifying clinical trial data for the purpose of profit also costs the sponsor in money and time lost as well as reputation harmed. FDA’s Office of Criminal Investigations is responsible for investigating cases like these. Adequate monitoring of sites and appropriate oversight of CROs can help identify risks before they become issues.

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- The Clinical Pathways Team

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