Design and analysis of clinical trials : concepts and methodologies /
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Author / Creator: | Chow, Shein-Chung, 1955- |
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Edition: | 2nd ed. |
Imprint: | Hoboken, N.J. : John Wiley, c2004. |
Description: | xiii, 729 p. : ill. ; 26 cm. |
Language: | English |
Series: | Wiley series in probability and statistics. |
Subject: | Clinical trials -- Methodology. Clinical trials -- Statistical methods. Clinical trials -- Methodology. Clinical trials -- Statistical methods. |
Format: | Print Book |
URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/5054034 |
Table of Contents:
- Preface
- Preface to the First Edition
- 1.. Introduction
- 1.1. What are Clinical Trials?
- 1.2. History of Clinical Trials
- 1.3. Regulatory Process and Requirements
- 1.4. Investigational New Drug Application
- 1.5. New Drug Application
- 1.6. Clinical Development and Practice
- 1.7. Aims and Structure of the Book
- 2.. Basic Statistical Concepts
- 2.1. Introduction
- 2.2. Uncertainty and Probability
- 2.3. Bias and Variability
- 2.4. Confounding and Interaction
- 2.5. Descriptive and Inferential Statistics
- 2.6. Hypothesis Testing and p-Values
- 2.7. Clinical Significance and Clinical Equivalence
- 2.8. Reproducibility and Generalizability
- 3.. Basic Design Considerations
- 3.1. Introduction
- 3.2. Goals of Clinical Trials
- 3.3. Target Population and Patient Selection
- 3.4. Selection of Controls
- 3.5. Statistical Considerations
- 3.6. Other Issues
- 3.7. Discussion
- 4.. Randomization and Blinding
- 4.1. Introduction
- 4.2. Randomization Models
- 4.3. Randomization Methods
- 4.4. Implementation of Randomization
- 4.5. Generalization of Controlled Randomized Trials
- 4.6. Blinding
- 4.7. Discussion
- 5.. Designs for Clinical Trials
- 5.1. Introduction
- 5.2. Parallel Group Designs
- 5.3. Cluster Randomized Designs
- 5.4. Crossover Designs
- 5.5. Titration Designs
- 5.6. Enrichment Designs
- 5.7. Group Sequential Designs
- 5.8. Placebo-Challenging Design
- 5.9. Blinded Reader Designs
- 5.10. Discussion
- 6.. Designs for Cancer Clinical Trials
- 6.1. Introduction
- 6.2. General Considerations for Phase I Cancer Clinical Trials
- 6.3. Single-Stage Up-and-Down Phase I Designs
- 6.4. Two-Stage Up-and-Down Phase I Designs
- 6.5. Continual Reassessment Method Phase I Designs
- 6.6. Optimal/Flexible Multiple-Stage Designs
- 6.7. Randomized Phase II Designs
- 6.8. Discussion
- 7.. Classification of Clinical Trials
- 7.1. Introduction
- 7.2. Multicenter Trial
- 7.3. Superiority Trials
- 7.4. Active Control and Equivalence/Noninferiority Trials
- 7.5. Dose-Response Trials
- 7.6. Combination Trials
- 7.7. Bridging Studies
- 7.8. Vaccine Clinical Trials
- 7.9. Discussion
- 8.. Analysis of Continuous Data
- 8.1. Introduction
- 8.2. Estimation
- 8.3. Test Statistics
- 8.4. Analysis of Variance
- 8.5. Analysis of Covariance
- 8.6. Nonparametrics
- 8.7. Repeated Measures
- 8.8. Discussion
- 9.. Analysis of Categorical Data
- 9.1. Introduction
- 9.2. Statistical Inference for One Sample
- 9.3. Inference of Independent Samples
- 9.4. Ordered Categorical Data
- 9.5. Combining Categorical Data
- 9.6. Model-Based Methods
- 9.7. Repeated Categorical Data
- 9.8. Discussion
- 10.. Censored Data and Interim Analysis
- 10.1. Introduction
- 10.2. Estimation of the Survival Function
- 10.3. Comparison between Survival Functions
- 10.4. Cox's Proportional Hazard Model
- 10.5. Calendar Time and Information Time
- 10.6. Group Sequential Methods
- 10.7. Discussion
- 11.. Sample Size Determination
- 11.1. Introduction
- 11.2. Basic Concept
- 11.3. Two Samples
- 11.4. Multiple Samples
- 11.5. Censored Data
- 11.6. Dose-Response Studies
- 11.7. Crossover Designs
- 11.8. Equivalence and Noninferiority Trials
- 11.9. Multiple-Stage Design in Cancer Trials
- 11.10. Comparing Variabilities
- 11.11. Discussion
- 12.. Issues in Efficacy Evaluation
- 12.1. Introduction
- 12.2. Baseline Comparison
- 12.3. Intention-to-Treat Principle and Efficacy Analysis
- 12.4. Adjustment for Covariates
- 12.5. Multicenter Trials
- 12.6. Multiplicity
- 12.7. Data Monitoring
- 12.8. Use of Genetic Information for Evaluation of Efficacy
- 12.9. Sample Size Re-estimation
- 12.10. Discussion
- 13.. Safety Assessment
- 13.1. Introduction
- 13.2. Extent of Exposure
- 13.3. Coding of Adverse Events
- 13.4. Analysis of Adverse Events
- 13.5. Analysis of Laboratory Data
- 13.6. Discussion
- 14.. Preparation and Implementation of a Clinical Protocol
- 14.1. Introduction
- 14.2. Structure and Components of a Protocol
- 14.3. Points to Be Considered and Common Pitfalls during Development and Preparation of a Procotol
- 14.4. Common Departures for Implementation of a Protocol
- 14.5. Monitoring, Audit, and Inspection
- 14.6. Quality Assessment of a Clinical Trial
- 14.7. Discussion
- 15.. Clinical Data Management
- 15.1. Introduction
- 15.2. Regulatory Requirements
- 15.3. Development of Case Report Forms
- 15.4. Database Development
- 15.5. Data Entry, Query, and Correction
- 15.6. Data Validation and Quality
- 15.7. Database Lock, Archive, and Transfer
- 15.8. Discussion
- Bibliography
- Appendices
- Index