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Session 4: Incorporating Mobile Technologies into Real World Evidence Studies
Session Chair(s)
Jacqueline A. Corrigan-Curay, JD, MD
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)
FDA, United States
Marni Hall, PhD, MPH
Vice President and General Manager, Global Regulatory Science and Strategy
IQVIA, United States
This session will explore the use of mobile technologies in generating RWE by examining the types of data that can be captured, e.g. patient reported data versus sensor data and trials designs used. Design features of the FDA MyStudies mobile app design and platform will be presented. Opportunities for integrating data from mobile technologies with other RWD sources, such as sensors, will be examined. Regulatory considerations for incorporating mobile technologies into clinical trials and how mobile technologies can facilitate decentralized trial designs and adherence will be discussed.
Learning Objective : At the conclusion of this session, participants should be able to:- Define at least two different uses for mobile technology in RWE studies
- Describe regulatory considerations for use of mobile technology data in RWE studies
- Discuss at least one regulatory consideration for trial designs using mobile technology
Speaker(s)
Incorporating Mobile Technologies into Real World Evidence Studies
David Martin, MD, MPH
Moderna, United States
Vice President, Global Head RWE
Speaker
Christopher Ceppi
Science 37, United States
Chief Product Manager
Creating a Path for Decentralized Clinical Trials
Pamela Tenaerts, MD, MBA
Medable, United States
Chief Scientific Officer
Practical Experience
Norman Stockbridge, MD, PhD
FDA, United States
Director, Division of Cardiology and Nephrology, OND, CDER
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