title: A novel Bayesian seamless phase I/II design.
abstract: This paper proposes a novel bayesian phase I/II design featuring using a hybrid mTPI method in phase I for targeting the MTD level and a randomization allocation schema for adaptively assigning patients to desirable doses in phase II. The mechanism of simultaneously escalating dose in phase I and expanding promising doses to phase II is inherited from a design proposed in literature. Extensive simulation studies indicate that our proposed design can vastly save sample size and efficiently assign more patients to optimal dose when compared to two competing designs.
authors.affiliation: Department of Health Statistics, Fourth Military Medical University, Xi'an, China ; School of Statistics, Xi'an University of Finance and Economics, Xi'an, China.
authors.forename: Haitao
authors.initials: H
authors.lastname: Pan
authors.forename: Ping
authors.initials: P
authors.lastname: Huang
authors.forename: Zuoren
authors.initials: Z
authors.lastname: Wang
authors.forename: Ling
authors.initials: L
authors.lastname: Wang
authors.forename: Chanjuan
authors.initials: C
authors.lastname: Li
authors.forename: Jielai
authors.initials: J
authors.lastname: Xia
mesh_terms: D001499:Bayes Theorem; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D020714:Maximum Tolerated Dose; D011336:Probability; D018401:Sample Size
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