Entirely remote online clinical trial has 'significant benefits'
According to Kai Langel, Director, Patient Solutions, eClinicalHealth, there are significant benefits in conducting a remote trial.
The VERKKO remote online Phase IV clinical trial for diabetes was developed in collaboration with Sanofi, Langland and Mendor. The study integrated eClinicalHealth’s online clinical trial platform with Mendor’s 3G-enabled wireless blood glucose meter in a completely remote clinical trial setting.
“Patient engagement was strong, and patient feedback is very useful and important,” Langel told Outsourcing-Pharma.com. “Patients also found the remote trial much more convenient, and they appreciated being able to establish their own schedule.”
In fact, when the researchers asked patients to report the hours they spent participating in the VERKKO remote trial, the majority commented they spent about the same time that it would have taken them to travel to and conduct a single study visit.
“The feedback from the study investigator was also very encouraging and the site's performance and efficiency gains were also very positive,” added Langel.
The study was conducted with a single site, which reported that the remote trial required two-thirds less management time than a traditional study.
“Designing studies with some elements of remote conduct and remote patient participation is extremely scalable in terms of flexibility and costs, especially in the real-world observatory setting where studies often involve thousands of patients,” added Langel.
“The time to study startup is less and overall costs are more affordable when compared to traditionally conducted studies.”
According to Langel, the team established a well-planned, collaborative approach among all parties, which allowed them to limit the difficult aspects of the trial.
However, she explained that confirming a patient’s identity is always a challenge remotely. Anticipating this challenge, Langel said it was dealt with successfully – as the Clinpal platform provides a mechanism for compliant electronic signatures.
“In using Clinpal for VERKKO, we considered a low risk study design; in the end, our identification process relied on the participants having to prove their identification in the post office when they picked up their study supplies — a process that was accepted by the ethics committee,” she explained.
Currently, the company is in discussion with other sponsors about more such trials and launching variations of pilot studies.
“Remote, online trials offer a lot of promise for conducting trials in a more efficient and patient-friendly manner; however, not every study is suitable for this process,” added Langel.
Specifically, he said that late-phase and observatory studies, or real-world evidence studies, are particularly suitable as they offer the greatest potential costs savings and are often the lower risk.
However, there are several aspects of a remote trial that can be applied to any trial, such as online recruitment, electronic informed consent, remote patient engagement and management and data capture.
“The site-patient relationship continues to be important and we want to support a strong collaboration at the site level,” said Langel. “Technology represents the biggest opportunity to move the industry forward at the moment.”