Design and analysis of clinical trials : concepts and methodologies /

Saved in:
Bibliographic Details
Author / Creator:Chow, Shein-Chung, 1955-
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
Hidden Bibliographic Details
Other authors / contributors:Liu, Jen-pei, 1952-
ISBN:0471249858
Notes:Previous ed.: 1998.
Includes bibliographical references (p. 649-682) and index.
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