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Virtual Event

18 ago 2020 8:00 a.m. - 19 ago 2020 3:45 p.m.

(US Eastern Standard Time)

Fort Washington, PA 19034

Digital Technology in Clinical Trials

Session 4 Track 1 & 2: Evaluation of Digital Technologies to Demonstrate Clinical and Analytical Validation

Session Chair(s)

Paul  Upham

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)

Ariel  Dowling, PhD

Speaker

Ariel Dowling, PhD

Takeda Pharmaceuticals, United States

Director of Digital Strategy

Jessilyn  Dunn, PhD

Speaker

Jessilyn Dunn, PhD

Duke University, United States

Assistant Professor of Biomedical Engineering

Thomas  Haag

Speaker

Thomas Haag

Cardinal Solutions Consuting, LLC, United States

Principal Consultant

Thomas  Switzer, MEd

Speaker

Thomas Switzer, MEd

Genentech, A Member of the Roche Group, United States

Principal Digital Health Scientist

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