By Ann Neuer
February 16, 2010 | One of the more intractable problems in clinical research is identifying which subjects are attempting to enroll in more than one study at once or have failed to meet the required waiting period between studies. Independent Data Integrator (IDI), a Florida-based provider of IT solutions, is addressing the longstanding challenge of identifying these so-called dual enrollers head on. With its Clinical Research Subject Verification Program, or clinicalRSVP, a Web-based subject registry, dual enrollers can be easily spotted and stopped from entering a study.
ClinicalRSVP uses fingerprint biometric identification technology and a handful of other pieces of identifying information, such as subject’s initials, date of birth, sex, and last four digits of the social security or tax-ID number. The subject is fingerprinted at the time of screening, after which the fingerprint is scanned, a code is generated and then stored in a database along with the other identifiers. Then, the database is searched for the potential subject and his or her most recent dose history.
Darran Boyer, president and CEO explains that this technology is straightforward and critical as dual enrollment can be dangerous to individuals and can damage the integrity of clinical trial data. Yet, some individuals are motivated by the compensation they receive, particularly in the more generously compensated Phase I clinical trials. “The problem stems from the incentive structure in today’s clinical trial landscape. Some subjects want to maximize their earnings, so they are willing to test or manipulate the system based on how much they want the money,” Boyer says.
Although potential subjects have to sign affidavits, there is little a site can do if a subject intentionally misrepresents the last time he or she was enrolled in a study or was dosed. But clinicalRSVP changes that dynamic. “clinicalRSVP allows investigators to make well-informed enrollment decisions without having to rely on a subject’s full disclosure,” he comments.
Users of clinicalRSVP are required to enter critical date information within eighteen hours of subject dosing. Data are entered at time of initial dose of enrolled subjects and at time of final dose. This requirement enables other clinical RSVP sites to see the dosing history of a potential subject and whether that individual was dosed within the past thirty days, a typical washout period for clinical trials.
To document the value of clinicalRSVP, IDI engaged five investigative sites in South Florida in a pilot study. Lasting from October through December 2009, the sites used clinicalRSVP in sixteen clinical trials, generating a database of 1,400 subjects. The average time spent checking prospective subjects against the database was 20 seconds per subject, and the average time spent per study to report dosing activity of subjects was 22 minutes.
In eight short weeks, the pilot study revealed a surprising number of attempted dual enrollers. Within 15 days of last dose, 18 individuals tried to dual enroll; within 30 days of receiving a dose in another study, the number jumped to 38 individuals; and within 60 days of last dose, 92 tried to screen. All were prevented from enrolling.
According to Boyer, “We weren’t surprised that so many people tried to dual enroll because we had heard the stories, but we weren’t sure how prominently the activity would be detected in the small South Florida pilot considering there was at least one major site that choose not to participate.”
Because of the limited scope of the pilot study, it is possible that many dual enrollers who approached other sites went undetected. To address this issue, Boyer says the best tactic is to encourage as many regional sites as possible to participate in clinicalRSVP, extending the reach of the tool and rendering it more effective. “As to what’s next, our goal is to provide a way to bring sites together in a regional sense. This concept won’t work if only one site in an area enrolls,” says Boyer.