6/15/2021
Photo by Tingey Injury Law Firm on Unsplash
A sub-investigator and an assistant coordinator working at a clinical research site in Florida pleaded guilty to conspiring to falsify clinical trial data. The two stated in their pleas that they conspired with others to make it appear that study participants were enrolled in and participating in two clinical trials when in fact the study data added to the medical records was fabricated and they did not participate in the clinical trials. Sentencing for this case occurs in August.
In another case occurring at the same clinical site as the plea case aforementioned, an investigator and others at the site were indicted on charges of falsifying clinical trial data over several years, including allegedly deliberately enrolling participants who did not meet the eligibility criteria and falsifying data on lab work, medical records, and documents claiming that participants were taking the investigational product when they did not. The investigator also allegedly provided a false statement to the Food and Drug Administration (FDA) regulatory inspector, another offense he is charged in.
In a third case also in Florida but at a different site, a coordinator was indicted on charges of falsifying pediatric clinical trial data. She allegedly falsified records to indicate that the pediatric study participants were going to their study visits, receiving investigational product, and receiving physical exams with the investigator, although the visits allegedly did not happen. When the FDA regulatory investigator questioned the coordinator, she allegedly provided a false statement.
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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Read our related blog, “Washington State Man Facing Prison for Clinical Trial Fraud” HERE.
- The Clinical Pathways Team
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