Seamlessly expanding a randomized phase II trial to phase III

DOI10.1111/J.0006-341X.2002.00823.XMaRDI QIDQ3079028zbMATH OpenWikidataFDO

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

Publication date 1 March 2011

Published in Biometrics (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1111/J.0006-341X.2002.00823.X

zbMATH Keywords

Bayesian sequential designclinical trialsMarkov chain Monte Carlomixture models

Mathematics Subject Classification ID

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

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Cites work

• A Stochastic Model for Censored-Survival Data in the Presence of an Auxiliary Variable
• Comparing the survival of two groups with an intermediate clinical event
• 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
• Discrete Sequential Boundaries for Clinical Trials
• scientific article; zbMATH DE number 3850330 (Why is no real title available?)
• scientific article; zbMATH DE number 1348603 (Why is no real title available?)
• scientific article; zbMATH DE number 3385132 (Why is no real title available?)
• Inference using surrogate outcome data and a validation sample
• Sampling-Based Approaches to Calculating Marginal Densities
• Two-stage selection and testing designs for comparative clinical trials
• Using Auxiliary Variables for Improved Estimates of Survival Time

Cited in

(14)

• A review of phase 2-3 clinical trial designs
• Bayesian two-stage design for phase II clinical trials with switching hypothesis tests
• Bayesian statistics and the efficiency and ethics of clinical trials
• Methodology and application of adaptive and sequential approaches in contemporary clinical trials
• SEAMLESS PHASE II/III CLINICAL TRIALS WITH COVARIATE ADAPTIVE RANDOMIZATION
• A Parallel Phase I/II Clinical Trial Design for Combination Therapies
• Discussion on “A Hybrid Selection and Testing Procedure with Curtailment for Comparative Clinical Trials” by Elena M. Buzaianu and Pinyuen Chen
• Bayesian group sequential enrichment designs based on adaptive regression of response and survival time on baseline biomarkers
• Two-stage randomized clinical trials with a right-censored endpoint: comparison of frequentist and Bayesian adaptive designs
• Multilevel joint frailty model for hierarchically clustered binary and survival data
• Joint modeling of binary response and survival for clustered data in clinical trials
• Design of phase III trials with long-term survival outcomes based on short-term binary results
• Adaptive seamless phase II/III design with sequential estimation-adjusted urn model
• Biomarker driven population enrichment for adaptive oncology trials with time to event endpoints

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