Stirling, Scotland, 16 June 2016 — eClinicalHealth Limited, a technology and consulting company dedicated to providing innovative clinical trial solutions, is proud to announce the final results and success of the VERKKO remote online Phase IV clinical trial for diabetes.
The objectives of VERKKO, developed in collaboration with Sanofi, Langland and Mendor, were to study the use of a patient-centric online clinical trial platform integrated with Mendor’s 3G-enabled wireless blood glucose meter in a completely remote clinical trial setting.
Sixty patients — all recruited through Facebook — participated in the study that had no site visits. Patients self-registered their interest in the Clinpal system, 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 smart, wireless glucose meter with their personal Clinpal account. Actively guided by the Mendor Smart glucose meter, patients completed an innovative 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 VERKKO results exceeded expectations in many areas:
- Seventy-four individuals registered interest, 60 of whom were enrolled in the study, an 81 percent conversion ratio, which is much better than typical online patient recruitment results.
- The average age of patients was 56 years old; several participants were 70 years and older, which demonstrates that such technology is suitable also for an elderly population.
- Patient satisfaction in study participation was very 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.
- Patients also were invited to comment about the study. Patient responses showed a high degree of enthusiasm and provided many good suggestions for improvements in future studies.
Improvements observed in relation to the comparator study:
- Fifty-one patients received their Mendor Smart meters and started the profiling protocol, with 46 completing the profiling process, a 9 percent drop-out rate, which was the same as in the comparator study. This is a good result considering that patient engagement was based on the online Clinpal system.
- Compliance improved 18 percent, meaning that patients required fewer total readings to complete the profiling protocol. This is significant in terms of patient convenience.
- Patients completed the glucose profiling 22 percent faster, signifying another convenience for patients that can also help get studies completed faster.
- The study site estimated having spent 66 percent less time in study coordination activities. The entire study was mainly managed between a single investigator and a study nurse.
The approach used in VERKKO is ideal especially for late-phase trials that often involve large patient populations and require a more efficient approach. However, online patient recruitment and engagement can benefit studies of any phase.
“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.