CRO owner admits to obstructing FDA inspection, falsifying data

A co-owner of a clinical research site, Unlimited Medical Research, pleaded guilty to obstructing a 2017 regulatory inspection in connection with an alleged scheme to fraudulently falsify clinical drug trial data, according to the U.S. Department of Justice.

The Florida-based CRO was one of several companies hired to conduct a clinical trial designed to investigate the safety and efficacy of Advair Diskus, GSK's inhaled asthma medication, in children.

According to court documents, Unlimited Medical Research's co-owner, Olga Torres, falsely portrayed the clinical trial as having been conducted legitimately when confronted by FDA inspectors — despite knowing that certain data associated with the clinical trial had been falsified.

GSK has previously told the media that it excluded the data from the VESTRI trial in all studies and reports.

Three other defendants — Unlimited's founder, Yvelice Villaman Bencosme; study coordinator Lisett Raventos; and employee Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the clinical trial.

The FDA Office of Criminal Investigations is currently investigating the case.