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Session 3: Methods/Strength of Evidence - Part 2
Session Chair(s)
Hans Ulrich Burger, PhD
Senior Director of Biostatistics
F. Hoffmann-La Roche Ltd., Switzerland
The totality of evidence into account in a systematic way for decision making at all stages of drug development will be discussed as well as innovative approaches to combine data from randomised trials and observational data.
Learning Objective : Participants will be able to will be able to compare and contrast new late-phase clinical trial designs. As a result, they will be able to design and formulate their Phase IIIb/IV clinical development plan more effectively.
Speaker(s)
Recently Developed Designs of Late-Phase Clinical Trials
Jonathan Alsop, PhD
Numerus, United Kingdom
Director
Embedding Randomized Controlled Trials into Medical Practice
Mario Ouwens, PhD
Astrazeneca, Sweden
Statistical science director
Christoph Gerlinger, MSc
Bayer Pharma AG, Germany
Senior Director, Statistics
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