The project, which took place at GSK’s Human Performance Lab, demonstrated that mHealth technologies have the power to comprehensively collect large volumes of reliable and secure data that can provide real-time, continuous insight into the well-being of patients.
The companies said that the FDA-compliant data and the general effort to involve 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 think there is expansive opportunity to apply mHealth technologies across clinical trials,” Kara Dennis, VP at Medidata Solutions, told Outsourcing-Pharma.com.
“Nearly all therapeutic areas could benefit from a more sophisticated understanding of subject phenotypic data, and mobile devices offer the opportunity to gather objective phenotypic insight directly from subjects.”
But she noted that industry is facing challenges in integrating technologies in a way that is operationally manageable, regulatory compliant, and engaging to patients and in a way that allows for the roll out of mHealth more broadly in clinical trials.
Glen de Vries, Medidata’s president, added: “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.”
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 data and activity levels. Participants also used Medidata’s mobile 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.
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 over the coming months. But the likelihood that sponsors will pick up on the use of mHealth quickly is still to be decided.
Matt Noble, senior director of product management at Medidata, told us: “The level of awareness of mHealth is remarkable, and many sponsors are interested in determining how devices and apps can improve clinical research. The first step towards widespread adoption will depend on the availability of a reliable, scalable, and regulatory compliant infrastructure that can support data generated by these devices as part of the clinical record, which we believe we’ve created in our work with GSK and other sponsors.”
And the speed at which mHealth will be added to clinical studies “also depends on how quickly the industry moves towards developing endpoints and biomarkers from this data, and in validating the data against markers of disease and disease trajectory. This is a significant big data challenge and opportunity,” Noble said.