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14:30
15 mins
Digital Biomarkers in Early Phase Clinical Trials Using a Remote Monitoring System: a Method Description
Ghobad Maleki, Robert-Jan Doll, Ernst-Jan Bos, Geert Jan Groeneveld, Adam Cohen
Session: Behavior & Monitoring
Session starts: Thursday 24 January, 13:30
Presentation starts: 14:30
Room: Lecture room 535


Ghobad Maleki (Centre for Human Drug Research)
Robert-Jan Doll (Centre for Human Drug Research)
Ernst-Jan Bos (Centre for Human Drug Research)
Geert Jan Groeneveld (Centre for Human Drug Research)
Adam Cohen (Centre for Human Drug Research)


Abstract:
The pharmacological treatment of mood disorders with available drugs is (partially) ineffective. Therefore, more effective antidepressant drugs are needed. However, a lack of objective biomarkers and reliance on subjective psychometric questionnaires to quantify drug effects hampers the development of novel drugs. Smartphone-based remote monitoring technologies may act as an addition to questionnaires in demonstrating pharmacodynamic (PD) effects in clinical trials. The Centre for Human Drug Research developed a platform allowing the measurement of social and physical activity based on smartphone and wearable sensors (REMOSTM). Here we describe this system in detail and provide an overview of future validation projects. REMOS is a platform which allows the remote monitoring of healthy subjects and patients, secure data storage, and data management. It includes an Android application for unobtrusive collection of data coming from the smartphone and connected wearable devices (e.g., Withings). The collected data contains data recorded by the smartphone sensors (location, IMU, microphone, and ambient light), as well as phone usage logs (e.g., app usage, call duration, and number of texts). All parameters and sample frequencies are configurable per study-protocol, allowing multiple simultaneous trials. A dashboard enables researchers to monitor the connections and potential data-loss. After validating the system according to GAMP5 procedures, REMOS will be included in upcoming trials to demonstrate the feasibility and validity. This will be done in two parts: (1) characterization and differentiation between healthy subjects and patients, and (2) studying the sensitivity to pharmacological interventions on physical and social behavior.