Medidata Completes Study Exploring Potential for Instrumenting Patients with Mobile Health Tools in a Clinical Trial Setting
NEW YORK, N.Y. – June 15, 2015 –
MOVE-2014 study participants exhibited high compliance with charging and using the mobile devices, which included wearable activity trackers and smartphones. The study also showed that quantifiable, objective data (i.e., movement levels and sleep patterns) from the activity trackers and subjective, patient-reported diary data collected via smartphones could be securely pulled into the
“The successful completion of MOVE-2014 reinforces what we at Medidata have discovered through a number of recent initiatives: mobile health solutions can be used to further clinical research in a reliable, secure and regulatory-compliant way,” said Glen de Vries, Medidata’s president. “Our goal was to show that mHealth tools can be incorporated into the highly structured world of clinical trials to unify in-life, direct-from-patient data with other information traditionally collected by researchers-providing a more holistic view of disease progression and patient response to therapy. We’re proud that our efforts are paving the way for life sciences companies to quickly adopt innovative technologies that have the potential to enhance data quality, trial efficiency and patient experiences.”
Analysis of the data from MOVE-2014 indicated that subjects were more than 90 percent compliant with wearing their activity trackers. Medidata’s data science team also identified a number of correlations in the data that could be tested in larger clinical trials, such as a relationship between activity and pain, and a connection between vigorous activity and weight loss.
Medidata intends to publish more specific information on MOVE-2014, detailing the protocol development and approval process, as well as how the Company deployed the mHealth devices and trained the MRA doctors and nurses who interacted with study participants. The Company is currently using the technology infrastructure developed for this initiative to enable Phase I–IV mHealth clinical trials for clients worldwide.
“In the past we have had to rely on subject reports of physical activity during clinical trials, and we know that this method is problematic,” said Dr. Diane Krieger, director of endocrinology and nutrition at MRA. “I was excited to use objective measurements of physical activity during the MOVE-2014 trial to attempt to capture activity in a more rigorous and standardized way.”
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