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Real World Evidence for Value and Access
Session Chair(s)
Marianne Hamilton Lopez, PHD, MPA
Research Director, Value-Based Payment Reform, Duke-Margolis Center For Health Policy, United States
Increasing availability of real-world data (RWD) and real-world evidence (RWE) has created justifiable excitement for stakeholders. The applications of RWD and RWE seem limitless – from trial optimization, directing R&D spend, and defining risk-sharing arrangements and value. Also, the role of RWD and RWE is becoming increasingly important to drug development and patient safety and has been cited as a significant priority of the FDA. Yet, there is still a lot of work to be done before the use of RWD and RWE is widespread and truly impactful. The session will explore this potential as well as the areas for further exploration, alignment, methods, and infrastructure development. Also, the session will present a study conducted by Tufts Center for the Study of Drug Development that examines current RWE data uses, sources of data, how data is being integrated and operational approaches supporting RWD use.
Learning Objective : Discuss the potential advantages and challenges, as well as return on investment, in using real-world data (RWD) and real world evidence (RWE); Assess the application of RWD and RWE for clinical research, value-based payment arrangements, and post-market safety surveillance; Describe emerging practices and definitions.
Speaker(s)
Mary Jo Lamberti, PHD, MA
Director of Sponsored Research, Research Associate Professor, Tufts Center for the Study of Drug Development, United States
Charles Makin
Global Head, Medical Health Outcomes Group, Biogen, United States
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