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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
Jennifer Goldsack, MA, MBA, MS
Digital Medicine Society (DiMe), United States
Chief Executive Officer
Developing an Evidence Dossier to Support the Use of Mobile Sensors to Collect Clinical Endpoints in Regulatory Submissions
Bill Byrom, PhD
Signant Health , United Kingdom
Vice President, Product Intelligence and Positioning; Principal, eCOA Science
Endpoint Hierarchy Considerations When Including New Objective Sensor-Based Clinical Endpoints
Emuella Flood
AstraZeneca, United States
Director, Patient-Reported Outcomes
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