A Phase IV clinical trial deemed “successful” by the firm that provided patient outreach technology for it is the type of new trial that will make the job of a clinical researcher coordinator (CRC) more “meaningful,” according to Kai Langel, director of patient research and cofounder of eClinicalHealth Limited. The diabetes trial recruited all of its patients using only Facebook.
Far from being any kind of threat to CRCs, who often are tasked with patient recruitment, this kind of technology will spare them from some of the tedious administrative work that takes away time more productively spent looking at patient data and helping keep trials on-track, Langel says. “CRCs shouldn’t go looking for a new career,” he stresses. “Their jobs won’t go away no matter how good the tool.”
Patients self-registered their interest in the study using the Clinpal system, eClinicalHealth’s online recruitment tool. The coordinating study site then reviewed applications. Selected patients were sent electronic information before electronically signing the informed consent form. Study materials were delivered directly to patients who used a smart, wireless glucose meter as part of the study. Glucose measurements were automatically sent from the device into the Clinpal system, and were then available for real-time review by patients and study site staff.
The study’s lead investigator and CRC “kept an eye” on the trial, Langel says. Patients also had a number to call the CRC with questions. The patient population skewed relatively elderly, Langel says, and most questions had to do with technology issues, such as when a participant didn’t access his or her initial link within the 24-hour key lock period. The CRC had to help guide them to setting up a new link to retrieve that information.
Seventy-four individuals registered interest in the study through Facebook, and 60 were ultimately enrolled, for an 81 percent conversion ratio. That’s a much better result than what is seen in typical online patient recruitment studies, according to eClinicalHealth. In addition, the study site estimated spending about two-thirds less of the investigator and study nurse’s time on recruitment versus the usual situation in a trial that did not use online recruitment.
Sanofi R&D is contributing to the study as part of a program to develop patient-centric clinical trials, according to eClinical Health.
Langel allows that this type of patient recruitment is best suited for trials seeking the most general of populations, such as asthma or diabetes, where the exclusionary criteria do not need to be particularly odious.
Want to learn more about volunteer recruitment and social media? Check out these sessions from the ACRP Online Conference Library:
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