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FDA Perspectives on Modernization of Clinical Trials: Real World Evidence, Decentralized Clinical Trials, and Digital Health Technologies
Session Chair(s)
Elizabeth Kunkoski, MS
Health Science Policy Analyst, OMP, CDER
FDA, United States
This forum will discuss FDA efforts to modernize clinical trials through real world evidence (RWE), decentralized clinical trials and the inclusion of digital health technologies. FDA experts will provide their perspectives on best practices for implementation.
Learning Objective : Design modern clinical trials to collect real-world data in real-world evidence settings; Discuss key principles of decentralized clinical trials and key aspects for their implementation; Discuss how to plan for the inclusion of digital health technologies for remote data acquisition in modern clinical trials.
Speaker(s)
Panelist
Leonard Sacks, MD
FDA, United States
Director, Clinical Methodologies,Office of Medical Policy, CDER
Panelist
Isaac R Rodriguez-Chavez, MHS, PhD, MS
Independant Consultancy, United States
Independant Consultant
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