Cloud-based solutions provider Medidata has announced the completion of a method development project conducted in partnership with GlaxoSmithKline (GSK) to evaluate the impact of unifying mHealth devices with cloud-based technologies in a clinical trial setting.
The joint initiative assessed the capabilities of modern mobile 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 can comprehensively collect large volumes of objective data to provide 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.
“We gathered data on an unprecedented scale — collecting more than 18 million data points on activity and vital signs per participant per day,” said Glen de Vries, Medidata’s president. “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.”
The joint initiative assessed the capabilities of modern mobile tools and evaluated how they could be used to enable a new model for clinical trial conduct.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 the Medidata Patient Cloud app for patient-reported outcomes. 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.
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. Furthermore, 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.