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Two-stage designs for Phase 2 dose-finding trials


Anastasia Ivanova, Department of Biostatistics, CB #7420, The University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7420, U.S.A.



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. Copyright © 2012 John Wiley & Sons, Ltd.