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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

FDA Perspectives on Modernization of Clinical Trials: Real World Evidence, Decentralized Clinical Trials, and Digital Health Technologies

Session Chair(s)

Elizabeth  Kunkoski, MS

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)

Leonard  Sacks, MD

Panelist

Leonard Sacks, MD

FDA, United States

Director, Clinical Methodologies,Office of Medical Policy, CDER

Isaac R Rodriguez-Chavez, MHS, PhD, MS

Panelist

Isaac R Rodriguez-Chavez, MHS, PhD, MS

Independant Consultancy, United States

Independant Consultant

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