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Using Mobile Sensors in Clinical Trials and Evidentiary Considerations for Electronic Submissions
Session Chair(s)
Bill Byrom, PHD
Vice President, Product Intelligence and Positioning; Principal, eCOA Science, Signant Health , United Kingdom
We will review the current work of the Study Endpoint Community wearables group. Specifically three areas: how to select a clinical endpoint derived from mobile sensor data; how to select a fit for purpose device and how to provide evidence to support its use; considerations regarding the positioning of endpoints derived from mobile sensor data alongside other clinical endpoints in the endpoint hierarchy.
Learning Objective : Identify the format and content of an evidence dossier to support clinical endpoints derived from wearable devices in regulatory drug submissions; Outline key considerations in the practical implementation of wearables to measure intervention effects in clinical trials; Discuss endpoint hierarchy considerations when including new objective sensor-based clinical endpoints.
Speaker(s)
Practical Considerations for the Implementation of Mobile Sensors for Measurement in Clinical Trials
Chief Executive Officer, Digital Medicine Society (DiMe), United States
Developing an Evidence Dossier to Support the Use of Mobile Sensors to Collect Clinical Endpoints in Regulatory Submissions
Vice President, Product Intelligence and Positioning; Principal, eCOA Science, Signant Health , United Kingdom
Endpoint Hierarchy Considerations When Including New Objective Sensor-Based Clinical Endpoints
Director, Patient-Reported Outcomes, AstraZeneca, United States
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