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Download Certificate ViewAttendees 14

Pharmaceuticals

Patient-Centric Endpoints and Use of Digital Health Technologies

Wednesday, May 8, 2024
11:45 – 12:45 CEST
Location: A 03 + A 04
Learning Level: Intermediate

Description:
  • This session discusses how to optimize designs of patient-centric clinical studies for drugs, biologics, and medical devices

  • Strategies to choose relevant outcomes to ensure demonstration of relevant treatment effect are proposed

  • Digital health technologies (DHTs) are a crucial — and ever increasing — tool used in patient-centric clinical trials for collection of data, but with innovation comes new questions on how to incorporate DHTs into studies

This session will provide an overview of the US FDA’s DHT Framework and key insights for development and qualification of DHTs for use in clinical trials.

Learning Objectives:

  • Upon completion, participant will gain understanding of US FDA’s DHT Framework and guidance for development and qualification of DHTs for use in clinical trials.
  • It will be demonstrated how study design and choice of relevant outcomes can be selected to ensure positive trial outcomes.