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Session 4 Track 1 & 2: Evaluation of Digital Technologies to Demonstrate Clinical and Analytical Validation
Session Chair(s)
Paul Upham
Head, Smart Devices
Roche / Genentech, United States
A critical aspect in the introduction of digital tools to clinical trials is assuring that you can demonstrate a valid clinical association between the tool’s output and the targeted clinical condition. You’ll learn from experts about how to do that and how to provide analytical validation that your digital tool correctly processes input data to generate accurate, reliable, and precise output data. Finally, learn how to ensure that your output data achieves your intended purpose in your target population in the context of clinical care.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe the basic approach for planning the process of clinical evaluation of a digital tool
- Understand the difference between: valid clinical association, analytical validation, and clinical validation
- Understand how these activities fit in the broader context of the clinical evaluation of digital tools and their use in clinical trials
Speaker(s)
Speaker
Ariel Dowling, PhD
Takeda Pharmaceuticals, United States
Director of Digital Strategy
Speaker
Jessilyn Dunn, PhD
Duke University, United States
Assistant Professor of Biomedical Engineering
Speaker
Thomas Haag
Cardinal Solutions Consuting, LLC, United States
Principal Consultant
Speaker
Thomas Switzer, MEd
Genentech, A Member of the Roche Group, United States
Principal Digital Health Scientist