Donna Dorozinsky, a Director of the Association of Clinical Pharmacology Units (ACPU), told Outsourcing-Pharma.com her organisation’s members –CROs and other groups performing Phase I research – have seen “significant reduction” in dual enrolment since they began using screening services.
It is forbidden for subjects to take part in more than one clinical trial at a time, but some individuals fraudulently sign up for several, either to receive payments or to obtain free medicine.
The results can be dangerous for the participants who may experience drug interactions and can skew trial data by registering false adverse effects. Some dual enrollers will register in trials sponsored by different companies, while others will travel back and forth between multiple sites of the same trial, often thousands of miles away in another state, Dorozinsky told us.
Specialist companies provide screening tech for CROs to prevent the problem, including Clinical RSVP, which takes fingerprints, and Verified Clinical Trials, which uses personal identifying information.
But the two methods are not compatible and CROs must choose which to use. “The challenge is that the two companies don’t talk to each other,” said Dorozinsky, allowing the potential for some cases of dual enrolment to slip through the cracks.
Mitchell Efros, President and CEO, Verified Clinical Trials, told us his company checks would-be subjects’ government-issued photo ID against an online trial database.
The system checks their enrolment status elsewhere, and provides safety alerts if the person has previously been exposed to a compound with a long half-life and will need to wait before joining another study.
The information is de-identified and anonymous, meaning the research site is not told any specifics of the subject’s other trials or their sponsors.
When we asked why the company does not use more rigorous biometric data, Efros told us it is a question he has debated, but settled for a method with a shorter set-up time.
“The problem with biometrics is you need to send a scanner or a device to all the sites, and that wouldn’t work well for Pfizer or Lilly or Novartis – they may have 300 sites.”
The database registry helps stop participants “telling the coordinator what they want to hear” about their symptoms to get into a trial, and then enrolling at different sites, Efron said. Some “toss their medicine away and collect their visit compensation” and there are online forums dedicated to coaching subjects on what to say to be accepted, he said.
With no verification company having full market share, we asked Verified Clinical Trials about the chances of dual enrollers slipping through the cracks between their different detection methods.
The fact that participants are aware these checks take place is in itself a deterrent, Efron replied. Clinical RSVP did not respond to our request for comment before publication.
Any system – “ours or theirs” is better than none, Efron told us, given that the number of fraudulent applications can reach up to 10%, especially for “subjective” studies into CNS, pain, depression and abuse liability and for early phase trials.