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Opening Remarks and Session 6: Sand in Your Shoes? The Nitty-Gritty in Generating Regulatory-Grade RWE Using Emerging Data Sources and New Platforms: Global Perspectives
Session Chair(s)
Rachele Hendricks-Sturrup, DrSc, MA, MSc
Research Director, Real-World Evidence
Duke-Robert J. Margolis, MD, Center for Health Policy, United States
The number of real-world data (RWD) sources available to generate real world evidence (RWE) has been increasing rapidly in recent years. The increasing availability and ease of access to data has been accompanied by numerous guidance documents and position papers among regulators, health technology assessment (HTA) bodies, and others that provide principled approaches to assessing fit-for-purpose RWD. While these documents and papers have enabled innovation in practice, they are accompanied by complexities that warrant the need for both pragmatism and close partnership and alignment of expectations among RWE developers and end-users.
Learning Objective : - Describe early signs of alignment on RWE standards, considerations, and definitions among regulators globally, including ongoing developments
- Describe the need for current guidance documents to be applied pragmatically to balance data innovation with scientific rigor
- escribe environmental, system, and study-specific challenges to leveraging RWE and solutions that balance RWD limitations with opportunities to improve population and patient health
Speaker(s)
Speaker
Lina Titievsky, PhD, MPH
GlaxoSmithKline, United States
Senior Director and Head of Hepatology Epidemiology
Speaker
Christian Hampp, PhD, FISPE
Regeneron, United States
Senior Director, Pharmacoepidemiology
Speaker
Jeffrey Brown, PhD
TriNetX, United States
Chief Scientific Officer
Speaker
Mina Tadrous, PharmD, PhD, MS
University of Toronto, Canada
Assistant Professor