Activity Trackers Adapted for Clinical Trial Data

Vivofit2 device (Garmin Ltd.)

9 February 2015. Medidata Solutions, a company providing cloud-based services for clinical trials, is teaming with Garmin Ltd., a provider of mobile GPS systems, to capture data from Garmin’s activity trackers worn by patients in clinical trials. Financial terms of the collaboration were not disclosed.

The deal involves integrating data from Garmin’s Vivofit activity trackers into Medidata’s Clinical Cloud service, an online system for design, planning, management, and reporting clinical trials. The Vivofit, worn on the wrist, captures number of steps taken and calories burned by the wearer, as well as his or her sleep and heart rate, and displays the data on the device in real time.

The device, which has a one-year battery life, can also connect to online services, which will enable the Clinical Cloud to collect the data automatically from trial patients. The company says it plans to upload Vivofit data every 15 minutes, where the data are stored and analyzed with traditional clinical trial measures for health status and response to therapies.

Medidata, based in New York City, says its system is built with data collection by mobile devices in mind. According to the company, its Patient Cloud, part of the overall Clinical Cloud system, can harness mobile data which reduces data collection errors from using paper forms and increase patient compliance in less complex studies. As a result, many trials can recruit fewer participants and reduce the time needed for data analysis and reporting.

In November 2014, Medidata and drug maker GlaxoSmithKline completed an evaluation of mobile health devices in clinical trials. The results, say the companies, show mobile technologies can securely capture large volumes of data with mobile devices and provide real-time insights into the health of trial participants. The data collected in the assessment were audited and found compliant with FDA regulations. In addition, the use of mobile data can reduce burdens on trial participants by streamlining routine procedures and reducing visits to trial sites.

Medidata says it is working with life sciences enterprises to test the use of Vívofit in clinical trials.

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