Study Coordinator Charged in Scheme to Falsify Clinical Trial Data

On 11 May 2021 a US Department of Justice federal grand jury returned an indictment charging conspiracy to falsify clinical trial data.

According to court documents, Jessica Palacio, 34, of Miami, Florida, worked as a study coordinator at a clinical trial firm in Miami called Unlimited Medical Research. Unlimited Medical Research was one of many companies hired to conduct a clinical trial designed to investigate the safety and efficacy of an asthma medication in children. The indictment alleges that Palacio participated in a scheme to falsify medical records to make it appear as though pediatric subjects made scheduled visits to Unlimited Medical Research, received physical exams from a clinical investigator, and took study drugs as required, when in fact these things had not occurred. The indictment also alleges that when Palacio was confronted by an FDA regulatory investigator about her conduct, she made a false statement to that investigator.

Palacio is charged with conspiracy to commit wire fraud and making a false statement. The defendant is expected to make her initial court appearance later this week in the U.S. District Court for the Southern District of Florida. If convicted, she faces a maximum penalty of 20 years in prison for conspiracy to commit wire fraud, and five years in prison for making a false statement. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.

The FDA’s Office of Criminal Investigations is investigating the case.

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