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NEW YORK, N.Y. – June 15, 2015 – Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the completion of MOVE-2014, a behavioral study the Company sponsored to test whether mobile health (mHealth) devices and tools could be used to drive better health outcomes in overweight adults with Type-2 Diabetes. The pilot open-label clinical trial is part of Medidata’s ongoing efforts to explore the challenges and opportunities associated with the adoption of mobile sensors, wearables and apps in clinical trials-and, in doing so, to enable a new model for drug development that aligns patient needs with faster study execution and reduced costs.
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 Medidata Clinical Cloud® platform-and seamlessly integrated with other clinical trial information-in a regulatory-compliant manner. Additionally, in assessing the feasibility of using a consumer-grade wearable device to monitor activity among people with Type-2 Diabetes in a real-world setting, MOVE-2014 demonstrated that continuous feedback on exercise and diet regimens could impact patient behavior and, ultimately, health outcomes: more than half of the study participants lost weight.
“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.”
Miami Research Associates (MRA), a multi-specialty clinical research center, conducted MOVE-2014 and studied 20 overweight adults with Type-2 Diabetes over an eight-week period. Trial participants were equipped with three mHealth technologies: a leading consumer-grade activity tracker-which was selected based on its ease of use-Medidata’s ePRO (electronic patient-reported outcomes) app Medidata Patient Cloud® and smartphones via which participants received text message notifications on nutrition and exercise. The text messages were designed to keep patients engaged with relevant updates from their doctors, while Patient Cloud was used to help study participants complete quality-of-life questionnaires. Medidata developed the technology infrastructure used to capture data from the mHealth tools, pull the data into the Medidata Clinical Cloud platform and integrate it with other clinical trial information gathered.
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.”