The trial was to be like any other that the clinical research organization (CRO) would oversee. The six-month study, known as VESTRI, would involve pediatric patients from age four to 11 who would receive one of two medications already approved for asthma, alone or in combination.
After their parents signed informed consent documents, the GlaxoSmithKline (GSK) protocol called for the children to have a screening visit, be randomized into the trial, and receive treatment appropriate to their level of symptoms.
To ensure they were closely monitored, the children were to “visit the clinic after two weeks, two months, four months, and six months,” and on a daily basis, their parents were to call an interactive voice response system “to record data about their asthma symptoms.” They also were to “speak with study staff by telephone at one month, three months, and five months post-randomization.”
As spelled out in court documents reviewed by RRC, that was the way it was supposed to work with Dr. Yvelice Villaman-Bencosme, who called her Pembroke Pines, Florida, pediatric practice Sacred Heart Medical Office PA. Perhaps Villaman-Bencosme had a special affinity for the children who were to be in the study—she herself has asthma that requires medication, Villaman-Bencosme would later testify during a hearing on her guilty plea.
Villaman-Bencosme contracted with the CRO in the fall of 2013, stating she would conduct the study from Unlimited Medical Research LLC, her facility in Miami. Her staff ultimately enrolled 107 patients in the study, for which they were paid $455,214.
But nothing went the way it was supposed to. Villaman-Bencosme is now in prison for 63 months and two of her coworkers are as well, with sentences ranging from 14 to 30 months. A fourth employee pleaded guilty last month and is awaiting sentencing this spring, and a fifth recently pleaded guilty.
Yet the crimes committed by Villaman-Bencosme and her coworkers are not unique—not nationwide nor even in Miami.
In fact, just last month, for part of his role in clinical trial fraud perpetrated by Tellus Clinical Research, also in Miami, Duniel Tejeda was sentenced to serve 30 months in prison and pay $2.1 million in restitution.
A former project manager and study coordinator, he joins two other former Tellus employees—Eduardo Navarro and Nayade Varon—who were sentenced in August 2021 to 46 and 30 months in prison, respectively, in connection with falsified trial data and given the same restitution requirement.
It is not known whether there was any connection between the two research organizations, but the techniques used in the frauds are remarkably similar. The cases show the level of deceptions that may occur—as well as the consequences if they are discovered by the federal government, whose officials recently have said prosecuting clinical trial fraud—wherever it exist—is a priority. The cases also show the need for large sponsors of research, such as universities, to understand—and mitigate—the risks posed by smaller sites.