Breaking New Ground with Remote Trials
Kai Langel, Director, eClinicalHealth outlines the benefits of conducting remote trials. Does this spell the end of the clinic?
Technology was the enabler, explains Kai Langel, who had wanted to carry out a similar trial a few years earlier but could not find a diabetes monitor with the needed usability and patient-friendliness.
Fast-forward to 2015, mix in Mendor’s 3G-enabled, wireless blood glucose meter and some funding from Sanofi R&D as part of its program to develop patient-centric clinical trials, and VERKKO was born.
“We really wanted to push the boundaries,” says Langel, adding that although the trial made provision for an investigative site, the goal was always to execute the trial completely remotely.
It was also a shot in the dark, he admits, as they had no idea how patients or staff would react. The greatest surprise was that there were no major problems. “We were doing something that no one had done before, so we really didn’t know what to expect. It went better than anyone had hoped.”
A key issue was that of identity – determining that the patients were who they said they were. This was overcome by requiring patients to collect their study materials from a local office and show their ID. Concerns about patient retention proved unfounded after a more traditional comparator study with a similar protocol showed similar rates of retention.
“Trials can be automated and with automation comes bigger scale. If you make things a little easier for patients, you get a much larger return.”
Ultimately, the industry wants “low-risk, high return” trials that are convenient for patients to participate in rather than “opening hundreds of trial sites globally and spending billions of dollars,” says Langel.
Siteless trials are ideal for large populations, including obtaining real-world evidence from patients using treatments already on the market. “Trials can be automated and with automation comes bigger scale. If you make things a little easier for patients, you get a much larger return.”
Providing patients with a portal is a powerful tool to maintain high levels of engagement, he says. “Giving patients a portal so they can see where they are in the study, what will happen next, offering reminders. That’s a very low-risk, high-return concept that you can apply to almost any trial. You get more retention and your patients are more engaged because they understand what the study is trying to do. This is something that is pretty easy to deploy.”
Feedback from patients was overwhelmingly positive, while trial staff spent one-third of the time and effort they expended on the comparator trial. “Staff had much less administration to do, and they didn’t have to spend time training patients. We can make sites much more efficient, and make it more convenient for the site so they can do more trials. I see this as an opportunity for sites to do more trials.”