Expect More Trials with mHealth Data

Medidata has done the legwork to allow companies to incorporate data from mobile health wearables into clinical trials.

Marie Thibault

June 18, 2015

4 Min Read
Expect More Trials with mHealth Data

Marie Thibault

Wearables and mobile apps have been infiltrating the traditional medical device industry bit by bit, and clinical trial software company Medidata is helping speed that movement. Medidata is a top provider of software and analytics for clinical trials, with clients that include the biggest pharmaceutical companies as well as medical device and diagnostic companies and academic centers. The company became intrigued by wearables and mobile health long before “mHealth” became a buzz word and has been exploring ways to incorporate the technology into clinical research trials.

Now, Medidata can point to data from its just-completed MOVE-2014 behavioral study that shows mobile health technology affects participant behavior. The eight-week, 20-patient, open-label study found that over 90% of the Type 2 diabetic patients were compliant in wearing activity trackers, more than 50% lost weight, and that qualitative data like sleep, patient observations, and movement could be transmitted safely to the Medidata Clinical Cloud platform, to be incorporated with other trial data in a way that meets regulations.

The trial included use of “a leading consumer-grade activity tracker,” the Medidata Patient Cloud app for patient self-reporting, and smartphones for text updates. The trial was run by Miami Research Associates (MRA). “In the past we have had to rely on subject reports of physical activity during clinical trials, and we know that this method is problematic,” Diane Krieger, MD, director of endocrinology and nutrition at MRA said in the press release. “I was excited to use objective measurements of physical activity during the MOVE-2014 trial to attempt to capture activity in a more rigorous and standardized way,” she said.

Medidata’s experience, including training needed to use such devices, should help the company replicate the incorporation of mobile health technology into client research trials—work they’ve already started for Phase I–IV trials globally. The company has enabled data from a number of wearables to be incorporated into clinical trials, including wearables from Garmin, Vital Connect, ActiGraph, the newly-public Fitbit, and most recently, the Apple ResearchKit. In November 2014, Medidata completed a collaborative method development project with GlaxoSmithKline plc using the Vital Connect HealthPatch MD and the ActiGraph wGT3X-BT monitor.

Back in late April, Kara Dennis, managing director of mHealth at Medidata Solutions, sat down with MD+DI at the company’s sleek, airy headquarters in New York’s SoHo neighborhood. She explained that the decision to run its own study (MOVE-2014) came from customer reactions. “When we decided to sponsor our own study, we’d been talking with a number of customers who were very interested but then just got scared,” Dennis says. Clients were concerned about the complexity and cost of such studies, so Medidata decided to test the waters themselves. “Basically we were like, ‘Let’s just do this. Let’s just work through all of the challenges. It was not always fun,’” Dennis laughs.

Medical device companies are prime candidates for trials using wearable devices and mobile health, Dennis notes, pointing out that Medidata has seen a lot of interest in the concept from device firms. “I think the companies that we’re talking to, they are a little further down the path with putting devices on users. They kind of get that world a little bit more . . . the potential here for working with our medical device customers is really exciting,” she says.

Medidata does a lot more than track data. Dennis explains that the company’s technology allows for secure data gathering and auditing before it is mapped to the other clinical data from the trial. She explains, “Statisticians and data scientists at our sponsors can form a comprehensive picture of what’s happening to the patient. Are they getting better as a result of therapy? Are they getting worse? That’s kind of the foundational question they’re looking to answer, which is—can they tell something of meaning clinically from this mobile health data?”

Medidata president and co-founder Glen de Vries pointed out the MOVE-2014 study’s benefits for future clinical trials. “We’re proud that our efforts are paving the way for life sciences companies to quickly adopt innovation technologies that have the potential to enhance data quality, trial efficiency and patient experiences,” de Vries said in the release.

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Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie


About the Author(s)

Marie Thibault

Marie Thibault is the managing editor for Medical Device and Diagnostic Industry and Qmed. Reach her at [email protected] and on Twitter @MedTechMarie.

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