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Session 2: Methods/Strength of Evidence - Part 1
Session Chair(s)
Sigrid Behr, PhD
Group Head Quantitative Safety & Epidemiology
Novartis Pharma AG, Switzerland
Randomised controlled trials are sometimes not feasible or not sufficient to fully assess the benefits and risks of a new drug. But how can observational data be incorporated in the pre- and post-approval data generation plan? This session will discuss frameworks for the use of observational data and provides guidance on how to enhance the reliability
Learning Objective : • Describe the SMART study design framework • Apply the framework to particular research questions to identify the design/data source that appropriately balances validity, stakeholder perspectives, feasibility and efficiency
Speaker(s)
Threshold Crossing - A Useful Way to Incorporate Historical Data in Pivotal Trials?
Martin Posch, PhD
Medical University of Vienna, Austria
Professor
Aspects of Observational Study Design that Enhance Reliability
Olaf Klungel, MPharm
Utrecht University, Faculty of Science, Netherlands
Professor of Pharmacoepidemiologic Methods
Mark Belger
Eli Lilly UK, United Kingdom
Senior Research Scientist - European Statistics (ACEJ-HTA/HO)
Identifying the Best Approach for Real-World Evidence Generation
Nicolle M. Gatto, PhD, MPH
Aetion, United States
Chief Science Officer
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