title: Two-stage designs for Phase 2 dose-finding trials.
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.
authors.affiliation: Department of Biostatistics, University of North Carolina, Chapel Hill, NC 27599-7420, USA. aivanova@bios.unc.edu
authors.forename: Anastasia
authors.initials: A
authors.lastname: Ivanova
authors.forename: Changfu
authors.initials: C
authors.lastname: Xiao
authors.forename: Yevgen
authors.initials: Y
authors.lastname: Tymofyeyev
mesh_terms: D001499:Bayes Theorem; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D003198:Computer Simulation; D004305:Dose-Response Relationship, Drug; D006801:Humans; D015233:Models, Statistical; D012107:Research Design