| Description |
1 online resource |
| Contents |
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 |
| Summary |
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 Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as |
| Notes |
Includes index |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record and CIP data provided by publisher |
| Subject |
Clinical trials -- Methodology
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Clinical trials -- Statistical methods
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Clinical Trials as Topic -- methods
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Research Design
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HEALTH & FITNESS -- Holism.
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HEALTH & FITNESS -- Reference.
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MEDICAL -- Alternative Medicine.
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MEDICAL -- Atlases.
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MEDICAL -- Essays.
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MEDICAL -- Family & General Practice.
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MEDICAL -- Holistic Medicine.
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MEDICAL -- Osteopathy.
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Clinical trials -- Methodology
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Clinical trials -- Statistical methods
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| Form |
Electronic book
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| Author |
Liu, Jen-pei, 1952-
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| LC no. |
2012027524 |
| ISBN |
9781118458143 |
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1118458141 |
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9781118458099 |
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1118458095 |
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9781118458136 |
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1118458133 |
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1118458168 |
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9781118458167 |
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0470887656 |
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9780470887653 |
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9781306133579 |
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1306133572 |
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