A Bayesian decision-theoretic sequential response-adaptive randomization design.

ABSTRACT: We propose a class of phase II clinical trial designs with sequential stopping and adaptive treatment allocation to evaluate treatment efficacy. Our work is based on two-arm (control and experimental treatment) designs with binary endpoints. Our overall goal is to construct more efficient and ethical randomized phase II trials by reducing the average sample sizes and increasing the percentage of patients assigned to the better treatment arms of the trials. The designs combine the Bayesian decision-theoretic sequential approach with adaptive randomization procedures in order to achieve simultaneous goals of improved efficiency and ethics. The design parameters represent the costs of different decisions, for example, the decisions for stopping or continuing the trials. The parameters enable

SUBMITTER: Jiang F 

PROVIDER: S-EPMC3873748 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature