The FDA approved its first fully remote clinical trial in 2012, but that attempt, by Pfizer and Exco InTouch, ended up folding and plans for a mulligan never came to fruition. Now Sanofi is backing another attempt at a fully remote trial, this time in Europe. Scotland-based eClinicalHealth will run the trial, called the VERKKO trial.
"This whole mechanism of doing studies in this manner is being investigated -- the feasibility," Kai Langel, the founder and director of patient solutions at eClinicalHealth told MobiHealthNews. "We’ll be [looking at] metrics like how many hours the patients spend in this trial. This will be compared with the traditional mechanisms. We have a sister study that was done in a manual manner and we have some data about that. So we can compare, not exactly one-to-one but we can get an idea of how much more efficient this will be than the traditional method."
Unlike the Pfizer trial, the intervention in this new trial isn't an older drug that had already been tested years before. The European study's intervention is a newer technology: a smart, wireless glucometer from Mendor that coaches patients on checking their glucose after learning from previous readings and schedules. Mendor's glucometer isn't smartphone-connected; instead, it has embedded cellular-connectivity and uploads user data directly to the cloud. Investigators can see all the data from the users, and the trial will produce outcomes and compliance data for Mendor.
While Sanofi doesn't have a drug or a device under investigation, it is providing a good deal of the funding, Langel said, because it's interested in using eClinicalHealth's online platform in its own clinical trials in the future. Called Clinpal, the technology supports fully online clinical trials from recruitment to data capture, and notably includes electronic informed consent.
Langel said his company started out pitching the online clinical trial as a cost-saving measure, but has discovered pharmaceutical companies are much more interested in saving time.
"They’re not really interested in the [upfront costs]," he said. "They say this is a blockbuster drug and we want to get it into the market as soon as we can, and if we have to put in a couple of extra million that’s absolutely fine. We were kind of taken aback because our key selling point was just taken out of the ring. In the pre-approval phase, the key is speed. We can recruit patients faster, we can retain patients better, and we can run through the trial faster. When you get to the post-approval phase, when the drug’s already in the market and you want to see how it’s performing, then it becomes about the cost and scalability."
eClinicalHealth is also working with healthcare communications agency Langland to drive recruitment via social media. Langel says the trial has already recruited 29 participants out of the hoped-for 60. Interestingly, he said, the average age of the patients, recruited primarily via Facebook, is 60.
"We expected a much younger population, but I guess that’s the thing with Facebook," he said. "It’s now used by much older people than it used to be. That was an interesting surprise for us."