Pharmaceutical company GlaxoSmithKline is using mobile health tools in a small study -- just six subjects -- that could lead to there more widespread use in clinical trials. The company is working with data startup Medidata and sensor makers Vital Connect and ActiGraph to evaluate the impact of wearable sensors in clinical trial settings.
“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,” Glen de Vries, Medidata’s president, said in a statement. “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."
In the study, conducted at GSK's Human Performance Laboratory, six healthy participants used Vital Connect's HealthPatch MD and ActiGraph's activity monitor to track their vital signs, electrocardiogram (ECG) data and activity levels. They uploaded this data into an app from Medidata, which in turn uploaded it into the lab's clinical record. Patients were asked to go through their normal daily routines, and only checked in with the lab at the beginning and end of the trial.
“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,” Dr. Nersi Nazari, Vital Connect’s chairman and chief executive officer, said in a statement. "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."
Next, Medidata’s data science team will work with GSK to try to turn the data from the study into "actionable insights" to help make clinical trials faster and more patient-centric, Medidata said in a statement. Medidata will also use the data to develop its own mobile-enabled clinical trial platform, which it will be recruiting clients for in the coming months.
In many ways, clinical trials are still the great unrealized promise of mobile health, despite ongoing efforts over the past two years. For its part, GSK has been quietly making a name for itself as a mobile-saavy pharmaceutical company. It scored above average in both number of apps and number of downloads in a recent Research2Guidance report about apps from pharma companies, and it scored second -- albeit a distant second -- in a major IMS report on which pharma companies were the best at social media that came out at the start of the year.