Bayesian Adaptive Methods for Clinical Trials
by Scott M. Berry; Bradley P. Carlin; J. Jack Lee; Peter MullerFormat: Nonspecific Binding
Pub. Date: 2010-07-19
Publisher(s): Taylor & Francis
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Summary
Driven by modern computing capabilities, there has been a rapid increase of interest in Bayesian methods for the analysis of clinical trial data. This book provides an introduction to Bayesian adaptive methods for the design and analysis of clinical trials. It presents background material on Bayesian inference and covers clinical trials in Phases I, II, and III. The methods are illustrated with many detailed examples and case studies using real data obtained by the authors in their extensive work. The examples are implemented using R and WinBUGS software, which is made available on a supporting website.
Table of Contents
| Statistical Approaches for Clinical Trials | |
| Introduction | |
| Comparisons between Bayesian and frequentist approaches | |
| Adaptivity in clinical trials | |
| Features and use of the Bayesian adaptive approach | |
| Basics of Bayesian Inference | |
| Introduction to Bayes' theorem | |
| Bayesian inference | |
| Bayesian computation | |
| Hierarchical modeling and metaanalysis | |
| Principles of Bayesian clinical trial design | |
| Appendix: R Macros | |
| Phase I Studies | |
| Rule-based designs for determining the MTD | |
| Model-based designs for determining the MTD | |
| Efficacy versus toxicity | |
| Combination therapy | |
| Appendix: R Macros | |
| Phase II Studies | |
| Standard designs | |
| Predictive probability | |
| Sequential stopping | |
| Adaptive randomization and dose allocation | |
| Dose ranging and optimal biologic dosing | |
| Hierarchical models for Phase II designs | |
| Decision theoretic designs | |
| Case studies: BATTLE and ISPY-2 | |
| Appendix: R Macros | |
| Phase III Studies | |
| Introduction to confirmatory studies | |
| Bayesian adaptive confirmatory trials | |
| Arm dropping | |
| Modeling and prediction | |
| Prior distributions and the paradigm clash | |
| Phase III cancer trials | |
| Phase II/III seamless trials | |
| Case study: Ablation device to treat atrial fibrillation | |
| Appendix: R Macros | |
| Special Topics | |
| Incorporating historical data | |
| Equivalence studies | |
| Multiplicity | |
| Subgroup analysis | |
| Appendix: R Macros | |
| References | |
| Author Index | |
| Subject Index | |
| Table of Contents provided by Publisher. All Rights Reserved. |
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