Medidata Collaborates with GlaxoSmithKline on Mobile Health Initiative to Test Novel Technology for Clinical Trial Optimization
Joint Initiative Evaluates Impact of mHealth and Cloud-Based Technologies on Patient Engagement, Data Quality and Operational Efficiencies in Clinical Trials
The collaborative project, which took place at
“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
“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.”
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