Document Detail

A Bayesian decision-theoretic sequential response-adaptive randomization design.
MedLine Citation:
PMID:  23315678     Owner:  NLM     Status:  MEDLINE    
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 us to incorporate the actual costs of the decisions in practice. The proposed designs allow the clinical trials to stop early for either efficacy or futility. Furthermore, the designs assign more patients to better treatment arms by applying adaptive randomization procedures. We develop an algorithm based on the constrained backward induction and forward simulation to implement the designs. The algorithm overcomes the computational difficulty of the backward induction method, thereby making our approach practicable. The designs result in trials with desirable operating characteristics under the simulated settings. Moreover, the designs are robust with respect to the response rate of the control group.
Fei Jiang; J Jack Lee; Peter Müller
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural     Date:  2013-01-13
Journal Detail:
Title:  Statistics in medicine     Volume:  32     ISSN:  1097-0258     ISO Abbreviation:  Stat Med     Publication Date:  2013 May 
Date Detail:
Created Date:  2013-05-08     Completed Date:  2014-01-02     Revised Date:  2014-06-02    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  1975-94     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 John Wiley & Sons, Ltd.
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MeSH Terms
Bayes Theorem*
Clinical Trials, Phase II as Topic / methods*
Computer Simulation
Decision Making*
Randomized Controlled Trials as Topic / methods*
Sample Size
Treatment Outcome
Grant Support

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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