Two-stage designs for Phase 2 dose-finding trials.
TLDR
A Bayesian adaptive two-stage design for the efficient estimation of the maximum dose or the minimum effective dose in a dose-finding trial that allocates subjects in stage two according to the posterior distribution of the target dose location.Abstract:
We propose a Bayesian adaptive two-stage design for the efficient estimation of the maximum dose or the minimum effective dose in a dose-finding trial. The new design allocates subjects in stage two according to the posterior distribution of the target dose location. Simulations show that the proposed two-stage design is superior to equal allocation and to a two-stage strategy where only one dose is left in the second stage.read more
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References
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Journal ArticleDOI
Bayesian data analysis.
TL;DR: A fatal flaw of NHST is reviewed and some benefits of Bayesian data analysis are introduced and illustrative examples of multiple comparisons in Bayesian analysis of variance and Bayesian approaches to statistical power are presented.
Journal ArticleDOI
On the likelihood that one unknown probability exceeds another in view of the evidence of two samples
Journal ArticleDOI
Order Restricted Statistical Inference.
Journal ArticleDOI
Combining multiple comparisons and modeling techniques in dose-response studies.
TL;DR: A unified strategy to the analysis of data from dose- response studies is described which combines multiple comparison and modeling techniques and assumes the existence of several candidate parametric models and uses multiple comparison techniques to choose the one most likely to represent the true underlying dose-response curve, while preserving the family-wise error rate.
Journal ArticleDOI
Testing and estimation in flexible group sequential designs with adaptive treatment selection.
Martin Posch,Franz Koenig,Michael Branson,Werner Brannath,Cornelia Dunger-Baldauf,Peter Bauer +5 more
TL;DR: This paper review adaptive treatment selection based on combination tests and propose overall adjusted p-values and simultaneous confidence intervals and point estimation in adaptive trials is considered.
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