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Joint Initiative Evaluates Impact of mHealth and Cloud-Based Technologies on Patient Engagement, Data Quality and Operational Efficiencies in Clinical Trials
Medidata (NASDAQ:MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the completion of a method development project conducted in partnership with GlaxoSmithKline plc (GSK) 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.
“Working with GSK on this initiative has 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,” said Glen de Vries, Medidata’s president. “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.”
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.
“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,” said Dr. Nersi Nazari, Vital Connect’s chairman and chief executive officer. "The availability of continuous, clinical-grade health data provides important opportunities to analyze results in real time to quickly identify potential safety concerns and adjust a trial based on preliminary evidence."
Medidata’s data science team is working with GSK to leverage the data from the project and turn it into actionable insight that can be used to conduct faster and more patient-centric clinical research. In addition, Medidata intends to use the technology infrastructure developed for this initiative as a model to enable new Phase I–IV mHealth clinical trials, which the company will be supporting for clients over the coming months.
“When it comes to mHealth, there is one aspect everyone agrees on: the technology is here now,” de Vries added. “Breakthroughs in mHealth adoption can come from clear demonstrations of using mobile devices in a compliant, effective and safe way. We believe these breakthroughs over time will help to alleviate any concerns about regulatory compliance and data quality, much like the early days of the Internet and electronic data capture.”