Medidata announced the completion of a method development project conducted in partnership with GlaxoSmithKline to evaluate the impact of unifying mobile health (mHealth) devices with cloud-based technologies in a clinical trial setting.
The joint initiative assessed the capabilities of mHealth tools and evaluated how they could be used to enable a new model for clinical trial conduct that aligns site and patient needs with faster study execution and reduced costs.
The collaborative project, which took place at GSK’s Human Performance Lab, demonstrated that mHealth technologies have the power to comprehensively collect large volumes of objective data that is reliable, secure and analysis-ready, and provides real-time, continuous insight into the well being of patients.
All of the data collected was audited and is compliant with FDA regulations.
Additionally, the effort indicated that mobile devices can support the long-term goal of lessening the burden on patients participating in studies by streamlining routine procedures, eliminating unnecessary ones and reducing visits to clinical trial sites.
During the project, Medidata and GSK provided program participants with two wearable devices—Vital Connect’s HealthPatch MD and ActiGraph’s wGT3X-BT Monitor—to continuously measure vital signs, electrocardiogram (ECG) data and activity levels.
In addition, participants used Medidata Patient Cloud, a mobile app for patient-reported outcomes offered as part of Medidata’s industry-leading technology platform.
The participants carried smartphones that captured data from the mHealth devices, pulled this data into the Medidata Clinical Cloud and then mapped it to the clinical record.
Participants were asked to go about their standard daily routine and checked in with the performance lab only at the start and end of the effort.
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