Wednesday, June 22 • 3:15pm - 3:45pm
#360 CH: Considerations for Establishing Meaningful Change for Digital Endpoints Derived From DHT Drug Development Tools

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Component Type: Workshop
Level: Intermediate

The use of digital health technologies (DHTs) in drug development is becoming more commonplace. Establishing meaningful change for digital endpoints is still in its infancy. We will explore the intersection of DHTs and meaningful change.

Learning Objectives

Discuss applying the common approaches to determine if MCID requires additional considerations; Describe insights from published digital endpoint qualification documentation and responses to submissions under review by various regulatory authorities.


Marie Mc Carthy, MBA, MSc


Marie Mc Carthy

Digital Endpoint Lead, Novartis, Ireland
With over 12 years’ experience supporting the use of digital health technologies in drug development studies and clinical research. I have spent these years not only evangelizing the value and benefit of digital endpoints derived from digital health technologies but also supporting... Read More →

Wednesday June 22, 2022 3:15pm - 3:45pm CDT
Room 470 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616