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Activity Number: 473
Type: Invited
Date/Time: Wednesday, August 3, 2016 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #318281 View Presentation
Title: Subgroup Analyses in Early-Phase Clinical Trials: Challenges and Opportunities
Author(s): Björn Bornkamp* and Marius Thomas
Companies: Novartis and Novartis
Keywords: subgroup ; resampling ; model averaging
Abstract:

Subgroup analyses in early phase trials are frequently conducted, both in a prospectively planned but also in a post-hoc manner. In particular the latter situation poses challenges for decision makers in their decision whether to proceed a compound to the next phase of development or not. This presentation reviews and compares recent statistical tools in exploratory subgroup analyses to deal with the challenges posed by evaluating multiple models and subgroups, for example in terms of estimates and uncertainty intervals for the treatment effect of a selected subgroup.


Authors who are presenting talks have a * after their name.

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