Umfang:
Online-Ressource (XIV, 204 p. 28 illus., 6 illus. in color, online resource)
Ausgabe:
1
ISBN:
9781461401407
Serie:
Applied Bioinformatics and Biostatistics in Cancer Research
Inhalt:
This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials
Anmerkung:
Description based upon print version of record
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Designs for Clinical Trials; Preface; Contents; Contributors; 1 Designs for Phase I Trials; 1 Introduction; 2 Algorithm-Based Designs; 2.1 Sequential Stepwise Tests; 2.2 Up-and-Down Designs via Random Walk; 2.3 Algorithm per Toxicity Probability Intervals; 3 Model-Based Designs; 3.1 The Continual Reassessment Method; 3.1.1 The Basic Approach; 3.1.2 Practical Modifications; 3.1.3 Model Specification; 3.2 Escalation with Overdose Control; 3.3 Curve-Free CRM; 4 Example: A Bortezomib Trial in Lymphoma Patients; 4.1 Method Comparison; 4.2 Simulation Results; 5 Theoretical Properties; 5.1 Coherence
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5.2 Consistency6 Further Topics; 6.1 Delayed Toxicities; 6.2 Toxicity Severity Scores; 6.3 Bivariate Designs; 7 Challenge Ahead: Implementation; References; 2 Randomized and Balancing Allocation Schemes for Clinical Trials: Computational Perspectives on Design and Deployment; 1 Conceptual Overview; 1.1 Basic Notions for Idealized Experiments; 1.2 Treatment Allocation Schemes; 1.2.1 Complete Randomization; 1.2.2 Permuted Blocks; 1.2.3 Coin- and urn-Based Allocation Schemes; 1.2.4 Minimization; 1.3 Stratification; 1.4 Inference Procedures: Rerandomization; 1.5 Exceptions to the Ideal Setting
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2 Computational Architectures for Allocation in Clinical Trials2.1 Experiment- and Patient-Level Data Structures; 2.2 Randomization Specification; 2.3 Cohort Simulation: Allocations; 2.4 Summary on Computational Infrastructure; 3 Evaluating Allocation Methods; 3.1 Departures from Target Allocation Ratios; 3.2 Avoiding Accidental Confounding; 3.3 Inference: Permutation vs. Rerandomization; 4 Discussion; References; 3 Sequential Designs for Clinical Trials; 1 Introduction; 2 The Fixed Design; 2.1 Normal Data; 2.2 Efficient Score Test; 2.3 Fixed Information; 3 Classical Group Sequential Design
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3.1 Computational Issues3.2 Maximum Sample Size and Inflation Factor; 4 Information-Based Group Sequential Design; 5 Information-Based Group Sequential Analysis; 6 An Example: CALGB 8433; 7 Discussion; References; 4 Sample Size Reestimation for Confirmatory Clinical Trials; 1 Introduction; 2 Negative Symptoms Schizophrenia Trial; 2.1 Fixed Sample Design; 2.2 Group Sequential Design; 2.2.1 The Problem of Overruns; 2.3 Adaptive Design; 2.3.1 Preserving the Type-1 Error; 2.3.2 Selecting the Criteria for an Adaptive Sample Size Increase; 2.3.3 Operating Characteristics of Adaptive Design
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3 Acute Coronary Syndromes3.1 Group Sequential Design; 3.2 Adaptive Group Sequential Design; 3.3 Operating Characteristics of Adaptive Group Sequential Design; 3.4 Adding a Futility Boundary; 4 Nonsmall Cell Lung Cancer; 5 Concluding Remarks; References; 5 On Stopping a Randomized Clinical Trial for Futility; 1 Introduction; 2 Inclusion of a Futility Boundary in a Protocol; 2.1 Trial and Sponsor Characteristics Favorable to Inclusion; 2.2 Trial and Sponsor Characteristics Less Favorable to Inclusion; 3 Factors Influencing a Decision to Terminate for Futility
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3.1 Reasons to Terminate for Futility
Weitere Ausg.:
ISBN 9781461401391
Weitere Ausg.:
Erscheint auch als Druck-Ausgabe ISBN 978-146-140-139-1
Sprache:
Englisch
DOI:
10.1007/978-1-4614-0140-7
URL:
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