Conducted at GSK's Human Performance Lab, the joint project evaluated the capabilities of mHealth tools and 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 project showed mHealth technologies can comprehensively collect large volumes of objective data that is reliable, secure and ready for analysis, providing real-time, continuous insight into patients' well being.
Complete data from the project was audited and is said to be compliant with US Food and Drug Administration (FDA) regulations.
"Complete data from the project was audited and is said to be compliant with US Food and Drug Administration (FDA) regulations."
In addition, the project showed mobile devices can support the long-term goal of lessening the burden on patients participating in studies by streamlining routine procedures and reducing visits to clinical trial sites.
Medidata president Glen de Vries said: "Working with GSK on this initiative provided us with an exciting opportunity to show how technology can be used to enhance patient engagement and accelerate the pace of innovation in drug development.
"We gathered data on an unprecedented scale, collecting more than 18 million data points on activity and vital signs per participant per day.
"This is an extraordinary level of in-life, real-time patient instrumentation for clinical trials, which will create new disciplines and new opportunities for life science companies."
In the project, participants were given 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.
Additionally, participants used Medidata Patient Cloud, a mobile app for patient-reported outcomes, offered as part of Medidata's technology platform.
Patients carried smartphones that captured data from mHealth devices, which pulled this data into the Medidata Clinical Cloud and then mapped it to the clinical record.
During the trial, patients were asked to continue their standard daily routine and checked in with the performance lab only at the start and end of the effort.
Vital Connect chairman Dr Nersi Nazari said: "Seamlessly integrating data from HealthPatch MD into clinical records through the Medidata Clinical Cloud opens up new possibilities to measure biometrics, from heart rate to skin temperature."
