Dual enrolment is the practice of participants taking part in multiple clinical trials simultaneously in order to benefit from increased compensation or healthcare.
It is a widely acknowledged that such behaviour can jeopardise both patient safety and the quality of clinical trial results, but a lack of hard data means the extant of the problem - and even if it is a significant issue at all - is a topic of considerable industry debate.
Outsourcing-Pharma.com spoke to the Association of Clinical Research Organisations (ACRO) regarding the occurrence of dual enrolment. VP of Public Affairs, John Lewis said: “We hear occasional, anecdotal reports about dual enrolment, mostly in Phase I trials, and believe it is an extremely rare occurrence.
“CROs work very hard to verify the eligibility of clinical trial participants to both protect the safety of the participants and ensure the integrity of the clinical trial data,” he continued to say. “Our members have built-in processes and use a variety of internal and external technologies to screen clinical trial participants for eligibility.”
ACRO’s views are at odds of those of Rahlyn Gossen, a specialist in patient recruitment, who told us “there is a tendency to underestimate the extent of dual enrolment because it is a mostly invisible problem compared to some of the more visible challenges we face in clinical trials.”
Gossen, who owns digital marketing company Rebar Interactive, continued: “I know of sponsors who, after systematically investigating dual enrolment in the midst of their trial, have been shocked to discover the scale of the problem.”
Unfortunately she could not divulge to us which specific companies had been affected but did say there were a number of companies offering services aimed at addressing this issue.
Response by CROs
Last week the New York-based CRO Clinilabs announced it was launching an initiative in order to tackle the issue, selecting clinical trials database solution company Verified Clinical Trials (VCT) to - according to Dr. Gary Zammit, President and CEO of Clinilabs – combat this “widespread issue” and help ensure subjects meet “inclusion/exclusion criteria.”
Zammit told Outsourcing-Pharma.com: “So far, VCT data shows that 6-11 % of the research subjects who have sought entry into a trial were either in another study, or in a lockout period, or were attempting to screen at a second facility while still in active screening Dual Screening Activity.”
Furthermore, “eleven percent of subjects provide false identity to the research sites to attempt to avoid taxes on research subject stipends.”
This figure supports research done by Kerri Weingard of Accumed Research Associates, who, in 2010, told this publication as many as 12 percent of trial subjects were dual enrolling - or, as she put it, ‘guinea-pigging’ – and 20 percent of those were signing up to over three trials per year.
“Only a few inappropriate patients in a trial can have a huge impact on results,” Zammit continued to explain, and the deal with VCT will work in unison with Clinilabs’ own “in-house database of 70,000 study candidates.” It will enable them to verify subject on the spot whilst adding more confidence in the safety of subjects in trials and an eventual streamlining of the screening process as the programme starts to act as a deterrent.
Further Complications
Patients who fraudulently attend multiple synonymous trials may well be further risking results. Zammit questioned whether people who gave inaccurate information on application were actually “taking the investigational product according to protocol when they are unsupervised at home,” or, indeed, at all?
Furthermore, Gossen discussed another less duplicitous complication that may compromise results. “Patients are increasingly going online to find health information, including information about clinical trials” and online discussions of clinical trials may lead to the “natural curiosity” of patients ‘unblinding’ themselves to the nature of the drug and trial.
“Fortunately, sponsors do have options for uncovering these attempts,” she said, with “sophisticated social media listening tools that proactive sponsors can use to detect potentially problematic online conversations so that they can take early action.”