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GSK tests mHealth trial solutions

Published on 19/11/14 at 01:24pm
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GlaxoSmithKline is experimenting with mobile health (mHealth) devices linked to cloud services in clinical trials as part of a bid to better engage with patients, speed up the process and capture data more effectively.

Working with US firm Medidata, GSK gave people two wearable devices – Vital Connect’s HealthPatch MD and ActiGraph’swGT3X-BT Monitor - to measure vital signs, electrocardiogram (ECG) data and activity levels.

In the research, carried out at GSK’s Human Performance Lab, patients had smartphones which took data from the mHealth devices, pulled it into the Medidata Patient Cloud mobile app and mapped it onto the clinical record.

The idea was to marry up mHealth and cloud services to see whether the combination would align site and patient needs with faster study execution and thereby save money.

Pharmafile caught up with Medidata’s president Glen de Vries at yesterday’s Financial Times pharma and biotech conference, and asked about teaming up with GSK, he said: “This was a phenomenal collaboration and I cannot say enough about how great of an experience our team had working with GSK. It was really collaborative and exciting; it’s always fun when you can do something new.”

Use of mHealth is increasingly prevalent across healthcare, despite concerns over the legitimacy of the data captured – although in this case the firms say the data collected was audited and complies with FDA regulations.

There are broader worries about the security of the cloud as far as patient data is concerned. In September Pharmafile reported that Apple, which unveiled its new Apple Watch this year, warned developers: “Don’t share data you’ve collected using [its] HealthKit.”

However, pharma risks falling behind in mobile mHealth as more innovative industries capitalise on its emerging opportunities, according to GSK’s global digital director Kai Gait and others, speaking on the subject earlier this year.

Medidata is certainly enthusiastic about the possibilities. “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 de Vries.

“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,” he adds.

Turning this mass of data into actionable insight is the next step, and Medidata says it intends to use the technology infrastructure developed with GSK as a model for new Phase I–IV mHealth clinical trials for other clients in the next few months.

Nersi Nazari, Vital Connect’s chairman and chief executive officer, says the trial “opens up new possibilities to measure biometrics, from heart rate to skin temperature”.

“The availability of continuous, clinical-grade health data provides important opportunities to analyse results in real time to quickly identify potential safety concerns and adjust a trial based on preliminary evidence,” he concludes.

Adam Hill

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