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Real World Evidence Conference

How Real World Evidence can be used for regulatory purposes

Session 4: Incorporating Mobile Technologies into Real World Evidence Studies

Session Chair(s)

Jacqueline A. Corrigan-Curay, JD, MD

Jacqueline A. Corrigan-Curay, JD, MD

  • Director, Office of Medical Policy, CDER
  • FDA, United States
Marni Hall, PhD, MPH

Marni Hall, PhD, MPH

  • Vice President, Clinical Evidence
  • 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)

David Martin, MD, MPH

Incorporating Mobile Technologies into Real World Evidence Studies

David Martin, MD, MPH

  • Vice President, Pharmacovigilance
  • Moderna, United States
Christopher Ceppi

Speaker

Christopher Ceppi

  • Chief Product Officer
  • Science 37, United States
Pamela Tenaerts, MD, MBA

Creating a Path for Decentralized Clinical Trials

Pamela Tenaerts, MD, MBA

  • Executive Director
  • Clinical Trials Transformation Initiative (CTTI), United States
Norman Stockbridge, MD, PhD

Practical Experience

Norman Stockbridge, MD, PhD

  • Director, Division of Cardiovascular and Renal Products, OND, CDER
  • FDA, United States

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