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Shall HTA Depend on Randomised Controlled Trials (RCT) or Real-World Data (RWD) or Both?
Session Chair(s)
Luca Pani, MD
Former, AIFA; Professor, Department of Psychiatry and Behavioral Sciences
University of Miami, United States
Shall HTA Depend on Randomised Controlled Trials (RCT) or Real-World Data (RWD) or Both?
Learning Objective : • To understand how regulatory, payer, healthcare professional and patient stakeholders value and use patient-reported outcome endpoints. • To understand the methods and timings for developing a robust, comprehensive and systematic PRO endpoint strategy that can meet the needs of all stakeholders in a single lifecycle program for a medication
Speaker(s)
Chris Chinn, MSc
Sanofi, United Kingdom
Real World Evidence for Market Access
Applying RCT Standards to RWD: Experiences with Post-Authorisation Efficacy Studies (PAES)
Giovanni Tafuri, PhD, MS
EUnetHTA, Netherlands
Senior Scientific Officer
Conducting HTA Using RWD
François Meyer, MD
French National Authority for Health (HAS), France
Advisor to the President, International Affairs
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