Scotland’s trial tech company eClinicalHealth and partners Sanofi ($SNY), U.K. consultant and ad company Langland and Finnish healthcare tech firm Mendor have posted positive results for their entirely remote online clinical study.
The “VERKKO” remote online Phase IV clinical trial for diabetes was run as a patient-centric, online clinical trial platform integrated with Mendor’s 3G-enabled wireless blood glucose meter in a completely remote clinical trial setting.
In all 60 patients--all of which were recruited through Facebook--participated in the study that had no site visits as patients adopted a type of ‘DIY trial’ with help from recruiters.
Patients self-registered their interest in the Clinpal system (which helps run trials online), after which the coordinating study site reviewed their application.
Patients who were selected reviewed electronic patient information before signing the informed consent form electronically. Study materials were delivered directly to patients who then connected the wireless glucose meter with their personal Clinpal account.
Actively guided by the Mendor Smart glucose meter, patients completed a glucose profiling protocol. Their glucose measurements were automatically transmitted from the device into the Clinpal system where they were available for real-time review by the patients and the study site.
Various performance indicators were compared with those from a previous study that used a similar study protocol--but with a more traditional site-based process.
The study saw 74 individuals register interest, 60 of whom were enrolled in the study--an 81% conversion ratio, which is much better than typical online patient recruitment results, according to the companies’ figures.
The average age of patients was 56 years old; several participants were 70 years and older, which eClinicalHealth says “demonstrates that such technology is suitable also for an elderly population,” a positive for the trial, given the misgivings many have for older patients being able to use online trial systems.
Patient satisfaction in study participation was positive, with a score of 4.52 out of 5, based on a survey done at the end of the trial. Asked to rate their satisfaction of Clinpal’s support for their study-related tasks, patients provided an average rating of 4.47 on a 5-point scale.
51 patients received their Mendor Smart meters and started the profiling protocol, with 46 completing the profiling process--a 9% drop-out rate, which was the same as a comparator study.
The study site estimated having spent 66% less time in study coordination activities--with the entire trial mainly managed between a single investigator and a study nurse, according to a statement.
“We are very pleased with the results that demonstrate that remote trials are not only operationally feasible, but deliver excellent performance and are very well accepted by both the patients as well as the researchers,” said Douglas Bain, eClinicalHealth’s CTO.
“We’re looking forward to transforming the clinical trial process and making this technology available to the industry.”
Sanofi R&D is contributing to the VERKKO study as part of its innovation program to develop patient-centric clinical trials, to assess the efficiency and perceived value from study participants.
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