Sanofi-backed virtual trial gets green light in Europe

Mendor Smart device--Courtesy of Mendor

A Sanofi ($SNY)-backed consortium has won clearance to run a virtual diabetes trial in Europe. The regulatory nod reportedly marks the first time European authorities have green-lit a clinical trial with full electronic informed consent.

Pfizer ($PFE) pioneered the virtual clinical trial model in the U.S. in 2012, and others--such as Shire ($SHPG)--have played around with electronic informed consent and other components of the study. The Sanofi-backed trial is a step forward for Europe, though. Sanofi has developed the project with three other organizations to assess the effectiveness of a 3G-enabled wireless blood glucose meter and a web-based patient-investigator communication system. No drug is being tested.

Finnish health tech firm Mendor is providing the remote glucose monitoring device. EClinicalHealth is behind the virtual trial system that will support recruitment, informed consent, communication and the collection of patient-reported outcomes. Healthcare ad agency Langland is responsible for patient recruitment. Langland has enrolled almost half of the 60-participant target, MobiHealthNews reports, with many people finding the study through a Facebook ($FB) campaign.

Pfizer struggled to recruit through social media, but the world has changed since 2012. The average age of the 29 participants enrolled to date in the Sanofi trial is 60 years old, an outcome that has surprised investigators who expected a younger demographic on Facebook. Evidence of the ability to recruit online and lessen the need for patients to visit investigator sites could be valuable to Sanofi, which is partly funding the study. The reasons Big Pharma values such things surprised eClinicalHealth.

"They're not really interested in the [upfront costs]. 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," eClinicalHealth founder Kai Langel told MobiHealthNews. The realization prompted eClinicalHealth to shift its pitch to emphasize its ability to speed patient recruitment and increase retention rates.

- read MobiHealthNews' article
- here's the release