How do people falsify clinical drug trial data?

On Behalf of | Apr 26, 2022 | Fraud

Medical-related disinformation is already pernicious, but bad actors sometimes enrich themselves by falsifying clinical trial data. In one such case, the project manager of a clinical research firm was in a conspiracy to falsify clinical drug trial data. The manager got sentenced to 30 months, and the investigation uncovered crimes by the clinic owner and another senior employee. The group reportedly investigated the claims of lying to the FDA, mail and wire fraud and money laundering but kept quiet. Companies in California should share any investigation results with local and federal agencies.

What does clinical research do?

Pharmaceutical companies sponsor clinical research trials to gather data for their experimental drugs. Pharmaceutical fraud can corrupt the data for drug effects and consumer safety. The pharmaceutical companies submit their study protocol to the FDA, and the study protocol explains drug doses, who participates and how long they measure the performance. Pharmaceutical companies or sponsors need to agree to the CRO contracts and FDA regulations. Multiple trials are going on at the same time, so sponsors need to reimburse the CRO a set amount per study participant. Some fees and Tellus sponsors pay the participants according to the study protocol.

The research firm gaming the eligibility requirements for studies

Every clinical trial needs patients to meet particular requirements for participation in studies. Instead of honestly recruiting participants with diagnoses for the trial, in the case of the clinical research firm, the defendants falsely claimed that the participants completed the requirements. Sometimes, they would recruit participants without applicable diagnoses. They would lie on the study protocol to gain more payments for participants from the trial sponsors. Defendants enrolled family and friends and even took personal information without consent. The co-conspirators falsified clinical notes by claiming they performed blood tests and medical exams.

Pharmaceutical fraud hurts consumers by compromising clinical trial data. Importantly, fraud may impact the FDA’s decision-making about the safety and effectiveness of drug reviews. A whistleblower could have reported what they found in the investigation to the FDA. If no one speaks up, fraudulent clinical trials can go to market. The department of justice needs whistleblowers to report any pharmaceutical fraud during an investigation.

FindLaw Network
Gary Jay Kaufman
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