Study Coordinator, Jessica Palacio Charged in Scheme to Falsify Clinical Trial Data
(STL.News) A federal grand jury in Miami, Florida, returned an indictment today charging a Florida woman with conspiring to falsify clinical trial data regarding an asthma medication.
According to court documents, Jessica Palacio, 34, of Miami, worked as a study coordinator at a clinical trial firm in Miami called Unlimited Medical Research. Unlimited Medical Research was one of many companies hi red 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 a Food and Drug Administration (FDA) regulatory investigator about her conduct, she made a false statement to that investigator.
“Falsifying clinical trial data risks the health and safety of those who might later rely upon the drugs being tested,” said Deputy Assistant Attorney General Arun G.