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Session 2: Statistical, Regulatory, and Operational Considerations for the Use of Digital Health Technologies and Endpoints in Clinical Trials
Session Chair(s)
Jonathan Haddad, MPH
HIV Disease Area Head, Clinical Statistics
GlaxoSmithKline, United States
Scott Komo, DrPH
Lead Mathematical Statistician, Office of Translational Sciences, CDER
FDA, United States
This session will briefly review the digital health technology landscape as it pertains to clinical trials. Examples of where digital health technology data/endpoints are incorporated in clinical trials and the statistical, regulatory, and operational considerations will be presented. Representatives from Working Groups in this space will discuss key challenges and next steps to realize greater integration of digital data (the future).
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand the potential uses of digital health technologies in drug development
- Gain awareness of key statistical and regulatory challenges with developing and analyzing digital health technology endpoint in clinical trials
- Gain of awareness of key logistical and operational challenges in using digital health technologies in clinical trials
Speaker(s)
Missing Data and Other Statistical Considerations for Wearable Activity Monitors in Clinical Trials
Andrew Potter, PhD
FDA, United States
Mathematical Statistician, OB, OTS, CDER
Digital Health Technology Tools in Clinical Trials: Challenges and Opportunities
Luis Garcia-Gancedo, PhD
GSK, United Kingdom
Director, Digital Biomarkers
Considerations for Operationalizing Digital Health Technologies
Tyler Reynolds
PA Consulting, United States
Digital Health Consultant
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