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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 that provide principled approaches in assessing the fitness of RWD. However, in practice, applying these approaches and recommendations has proven complex and time-consuming, highlighting the need for pragmatism and a close partnership with data owners/providers/aggregators and alignment of expectations across key stakeholders. During this session, panelists will describe their individual experiences in assessing whether a novel data source can be practically used in a timely manner to address a specific research objective(s) and ensure credibility and validity.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the need for current guidance documents to be applied pragmatically to balance data innovation with scientific rigor
- Learn international regulatory and practical perspectives in applying a principled approach to assess RWD’s fit for purpose, insights on cross-jurisdictional issues, and challenges in conducting international studies
Speaker(s)
Speaker
Lina Titievsky
GlaxoSmithKline, United States
Senior Director and Head of Hepatology Epidemiology
Speaker
Rachel Sobel, DrPH, FISPE
Regeneron , United States
Pharmacoepidemiology and Risk Management Center of Excellence
Speaker
Representative Invited
TriNetX, United States
Speaker
Representative Invited
Assistant Professor, Canada