DOJ Pursues Alleged Trial Data Falsification at Miami Site
The U.S. Department of Justice (DOJ) announced that three members of a Miami-based research center have been charged for allegedly running a years-long scheme to falsify clinical trial data for profit.
According to the DOJ, Miguel Montalvo, Bernardo Garmendia and Ivette Portela have all been charged with conspiracy to commit wire fraud and one substantive count of wire fraud. Montalvo was additionally charged with giving a false statement to an FDA investigator.
The indictment alleges that from Sept. 2015 through March 2018, and possibly longer, the trio extensively fabricated data in a trial being conducted at AMB Research Center, where Montalvo and Garmendia were co-owners. According to the indictment, the three knowingly enrolled participants that failed to meet eligibility criteria, faked participant laboratory results, falsified participant medical records and falsely represented that participants were taking the investigational product when they were not.
Montalvo served as lead study coordinator for the site, Garmendia as a study coordinator and Portela as a pharmacy tech. If convicted, the trio could face up to 20 years in federal prison for the wire fraud charge and an additional 20 years for the conspiracy charge.
Making false statements to the FDA carries a maximum penalty of five years in prison and a maximum fine of $250,000 or double the gain or loss caused by the offense, whichever is greater, according to the DOJ.
According to ClinicalTrials.gov, AMB Research Center was taking part in multiple trials, including an Alzheimer’s agitation trial, a knee/hip osteoarthritis trial and a major depression with psychotic features trial. No website for the company could be located.