GlaxoSmithKline ($GSK) and Medidata ($MDSO) have moved mHealth tools one step closer to the clinical trial mainstream. Having run a pilot project, the partners have concluded that mHealth technologies can deliver reliable, FDA-compliant data and improve the clinical trial experience for patients.
Medidata and GSK ran the pilot at the latter's Human Performance Lab, a site that works to improve strength, stamina and other attributes. Each participant was given two wearable devices, Vital Connect's HealthPatch MD and ActiGraph's wGT3X-BT Monitor. The devices gathered continuous data on vital signs, activity levels and heart rhythms, which were fed into smartphones carried by all of the participants. Medidata's Clinical Cloud collated the data and mapped it to the clinical record.
The partners are pleased with the results. "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 President Glen de Vries said in a statement.
Having validated the ability of the devices to gather reliable data and their potential to free clinical trial participants from the need to visit sites, Medidata has more mHealth projects in the pipeline. The eClinical specialist plans to use the technology developed in the pilot as the basis for other mHealth-enabled clinical trials.
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