The collaboration has the potential to enable Medidata clients to enhance clinical trials with use of the new device. A number of the clients requested the use of a new mobile health (mHealth) device to enhance patient engagement, data quality and operational efficiencies in clinical trials.
Kara Dennis, VP of Medidata, told Outsourcing-Pharma.com that Medidata is currently working on a couple of early stage or proof-of-concept trials and exploring the opportunity to gather new types of data and understand the relationship between that data and trial endpoints.
Designed to be worn on a person’s wrist, Garmin’s water-resistant vívofit measures steps taken, distance, calories burned and hours slept. The company selected the vívofit because of the ease of use provided by its year-long battery life, which can improve the convenience and speed associated with capturing direct-from-patient data.
In the short term, Dennis told us, there’s an opportunity to get insight quickly for companies on the value of the data coming from vívofit and over the longer term there will be more exploration as an increasing number of sponsors take on this type of trial.
She added that as far as benefits, patients will be able to access more info on their health status and activities via their phone, while over the longer term, devices like the vívofit could potentially reduce or replace clinical visits and provide physicians with more resourceful data when patients do come in for a visit.
This also isn’t Medidata’s first foray into mobile health technologies. Medidata previously partnered with GlaxoSmithKline to evaluate the use of mobile health devices with cloud-based tech in clinical trials. The GSK trials have now been completed, Dennis told us, and are being evaluated currently for how the data impacted the results of the trial.
And as the industry continues to develop, even the FDA has weighed in with preliminary guidance on wearables, which some in the industry think could slow pharma adoption of wearables in the near-term.
Dennis told us that more regulatory clarity will give life science companies the ability to move forward. “It’ll be an iterative process,” she said, noting that the testing of these devices is still in early stages and companies are just beginning to share data with FDA and receive feedback. “We’re just at the start of the iterative feedback loop with the agencies,” she added.