Design and analysis of clinical trials : concepts and methodologies /

Praise for the Second Edition: " ... a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite."--Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trial...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Chow, Shein-Chung, 1955-
Otros Autores: Liu, Jen-pei, 1952-
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : Wiley, ©2013.
Edición:3rd ed.
Temas:
Clinical trials > Methodology.
Clinical trials > Statistical methods.
Clinical Trials as Topic > methods
Research Design
Études cliniques > Méthodologie.
Études cliniques > Méthodes statistiques.
HEALTH & FITNESS > Holism.
HEALTH & FITNESS > Reference.
MEDICAL > Alternative Medicine.
MEDICAL > Atlases.
MEDICAL > Essays.
MEDICAL > Family & General Practice.
MEDICAL > Holistic Medicine.
MEDICAL > Osteopathy.
Clinical trials > Methodology
Clinical trials > Statistical methods
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Machine generated contents note: pt. I PRELIMINARIES
  • 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. Hypotheses 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
  • pt. II DESIGNS AND THEIR CLASSIFICATIONS
  • 5. Designs for Clinical Trials
  • 5.1. Introduction
  • 5.2. Parallel Group Designs
  • 5.3. Clustered Randomized Designs
  • 5.4. Crossover Designs
  • 5.5. Titration Designs
  • 5.6. Enrichment Designs
  • 5.7. Group Sequential Designs
  • 5.8. Placebo-Challenging Designs
  • 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 and Flexible Multiple-Stage Designs
  • 6.7. Randomized Phase II Designs
  • 6.8. Discussion
  • 7. Classification of Clinical Trials
  • 7.1. Introduction
  • 7.2. Multicenter Trials
  • 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 and Global Trials
  • 7.8. Vaccine Clinical Trials
  • 7.9. QT Studies
  • 7.10. Discussion
  • pt. III ANALYSIS OF CLINICAL DATA
  • 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. Nonparametric Methods
  • 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. Multinational Trials
  • 11.11. Comparing Variabilities
  • 11.12. Discussion
  • pt. IV ISSUES IN EVALUATION
  • 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 Reestimation
  • 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. Analysis of QT/QTc Prolongation
  • 13.7. Discussion
  • pt. V RECENT DEVELOPMENT
  • 14. Biomarkers and Targeted Clinical Trials
  • 14.1. Introduction
  • 14.2. Concepts and Strategies
  • 14.3. Biomarker Development and Validation
  • 14.4. Designs of Targeted Clinical Trials
  • 14.5. Analyses of Targeted Clinical Trials
  • 14.6. Discussion
  • 15. Trials for Evaluating Accuracy of Diagnostic Devices
  • 15.1. Introduction
  • 15.2. Study Design
  • 15.3. Measures of Diagnostic Accuracy
  • 15.4. Reporting Results
  • 15.5. Sample Size Estimation
  • 15.6. Discussion
  • 16. Statistical Methods in Translational Medicine
  • 16.1. Introduction
  • 16.2. Biomarker Development
  • 16.3. Bench-to-Bedside
  • 16.4. Animal Model Versus Human Model
  • 16.5. Translation in Study Endpoints
  • 16.6. Bridging Studies
  • 16.7. Discussion
  • 16.8. Appendix
  • 17. Adaptive Clinical Trial Designs
  • 17.1. Introduction
  • 17.2. What Is Adaptive Design?
  • 17.3. Well-Understood and Less Well-Understood Designs
  • 17.4. Clinical/Statistical and Regulatory Perspectives
  • 17.5. Impact of Protocol Amendments
  • 17.6. Challenges in By-Design Adaptations
  • 17.7. Obstacles of Retrospective Adaptations
  • 17.8. Discussion
  • 18. Traditional Chinese Medicine
  • 18.1. Introduction
  • 18.2. Fundamental Differences
  • 18.3. Basic Considerations of TCM Clinical Trials
  • 18.4. Other Issues in TCM Research and Development
  • 18.5. Consortium for Globalization of Traditional Chinese Medicine
  • 18.6. Discussion
  • pt. VI CONDUCT OF CLINICAL TRIALS
  • 19. Preparation and Implementation of a Clinical Protocol
  • 19.1. Introduction
  • 19.2. Structure and Components of a Protocol
  • 19.3. Points to be Considered and Common Pitfalls During Development and Preparation of a Protocol
  • 19.4. Common Departures for Implementation of a Protocol
  • 19.5. Monitoring, Audit, and Inspection
  • 19.6. Quality Assessment of a Clinical Trial
  • 19.7. Discussion
  • 20. Data Management of a Clinical Trial
  • 20.1. Introduction
  • 20.2. Regulatory Requirements
  • 20.3. Development of Case Report Forms
  • 20.4. Database Development
  • 20.5. Data Entry, Query, and Correction
  • 20.6. Data Validation and Quality
  • 20.7. Database Lock, Archive, and Transfer
  • 20.8. Critical Issues.

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