Seamlessly Expanding a Randomized Phase II Trial to Phase III

DOI10.1111/j.0006-341X.2002.00823.xzbMath1210.62168WikidataQ52025987 ScholiaQ52025987MaRDI QIDQ3079028

Donald A. Berry, Peter F. Thall, Lurdes Y. T. Inoue

Publication date: 1 March 2011

Published in: Biometrics (Search for Journal in Brave)

zbMATH Keywords

Markov chain Monte Carloclinical trialsmixture modelsBayesian sequential design

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10) Bayesian inference (62F15) Medical applications (general) (92C50) Sequential statistical design (62L05)

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Cites Work

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• Discrete Sequential Boundaries for Clinical Trials
• Sampling-Based Approaches to Calculating Marginal Densities
• Two-stage selection and testing designs for comparative clinical trials
• Inference using surrogate outcome data and a validation sample
• A Stochastic Model for Censored-Survival Data in the Presence of an Auxiliary Variable
• Using Auxiliary Variables for Improved Estimates of Survival Time
• Decision Theoretic Designs for Phase II Clinical Trials with Multiple Outcomes
• Design and analysis of group sequential tests based on the type I error spending rate function
• Comparing the survival of two groups with an intermediate clinical event