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Session 4: Examples
Session Chair(s)
Andrew Thomson, PHD, MA, MS
Statistician, Methodology Taskforce
European Medicines Agency, Netherlands
Observational data where considered the best available / achievable information in a growing number of situations will be looked at. This session will also present recent examples and experiences for the use of observational data
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)
Erwan Muros-Le Rouzic
Actelion, Switzerland
Epidemiologist
An Example of a Single Arm Pivotal Study in a Rare Disease
Carol Reid, PHD
Roche Products Ltd, United Kingdom
Biostatics Manager
Do Dynamic Borrowing Methods Control the Risk of Using Historical Data?
David Dejardin
F. Hoffmann-La Roche, Switzerland
Biostatistician