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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...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, N.J. :
Wiley,
©2013.
|
| Edición: | 3rd ed. |
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 100 | 1 | |a Chow, Shein-Chung, |d 1955- |1 https://id.oclc.org/worldcat/entity/E39PBJbRfVgHHGK9pByJv8TPwC | |
| 245 | 1 | 0 | |a Design and analysis of clinical trials : |b concepts and methodologies / |c Shein-Chung Chow, Jen-Pei Liu. |
| 250 | |a 3rd ed. | ||
| 260 | |a Hoboken, N.J. : |b Wiley, |c ©2013. | ||
| 300 | |a 1 online resource | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 500 | |a Includes index. | ||
| 588 | 0 | |a Print version record and CIP data provided by publisher. | |
| 504 | |a Includes bibliographical references and index. | ||
| 520 | |a 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. | ||
| 505 | 0 | 0 | |g Machine generated contents note: |g pt. I |t PRELIMINARIES -- |g 1. |t Introduction -- |g 1.1. |t What are Clinical Trials? -- |g 1.2. |t History of Clinical Trials -- |g 1.3. |t Regulatory Process and Requirements -- |g 1.4. |t Investigational New Drug Application -- |g 1.5. |t New Drug Application -- |g 1.6. |t Clinical Development and Practice -- |g 1.7. |t AIMS and Structure of the Book -- |g 2. |t Basic Statistical Concepts -- |g 2.1. |t Introduction -- |g 2.2. |t Uncertainty and Probability -- |g 2.3. |t Bias and Variability -- |g 2.4. |t Confounding and Interaction -- |g 2.5. |t Descriptive and Inferential Statistics -- |g 2.6. |t Hypotheses Testing and p-Values -- |g 2.7. |t Clinical Significance and Clinical Equivalence -- |g 2.8. |t Reproducibility and Generalizability -- |g 3. |t Basic Design Considerations -- |g 3.1. |t Introduction -- |g 3.2. |t Goals of Clinical Trials -- |g 3.3. |t Target Population and Patient Selection -- |g 3.4. |t Selection of Controls -- |g 3.5. |t Statistical Considerations -- |g 3.6. |t Other Issues -- |g 3.7. |t Discussion -- |g 4. |t Randomization and Blinding -- |g 4.1. |t Introduction -- |g 4.2. |t Randomization Models -- |g 4.3. |t Randomization Methods -- |g 4.4. |t Implementation of Randomization -- |g 4.5. |t Generalization of Controlled Randomized Trials -- |g 4.6. |t Blinding -- |g 4.7. |t Discussion -- |g pt. II |t DESIGNS AND THEIR CLASSIFICATIONS -- |g 5. |t Designs for Clinical Trials -- |g 5.1. |t Introduction -- |g 5.2. |t Parallel Group Designs -- |g 5.3. |t Clustered Randomized Designs -- |g 5.4. |t Crossover Designs -- |g 5.5. |t Titration Designs -- |g 5.6. |t Enrichment Designs -- |g 5.7. |t Group Sequential Designs -- |g 5.8. |t Placebo-Challenging Designs -- |g 5.9. |t Blinded Reader Designs -- |g 5.10. |t Discussion -- |g 6. |t Designs for Cancer Clinical Trials -- |g 6.1. |t Introduction -- |g 6.2. |t General Considerations for Phase I Cancer Clinical Trials -- |g 6.3. |t Single-Stage Up-and-Down Phase I Designs -- |g 6.4. |t Two-Stage Up-and-Down Phase I Designs -- |g 6.5. |t Continual Reassessment Method Phase I Designs -- |g 6.6. |t Optimal and Flexible Multiple-Stage Designs -- |g 6.7. |t Randomized Phase II Designs -- |g 6.8. |t Discussion -- |g 7. |t Classification of Clinical Trials -- |g 7.1. |t Introduction -- |g 7.2. |t Multicenter Trials -- |g 7.3. |t Superiority Trials -- |g 7.4. |t Active Control and Equivalence/Noninferiority Trials -- |g 7.5. |t Dose-Response Trials -- |g 7.6. |t Combination Trials -- |g 7.7. |t Bridging Studies and Global Trials -- |g 7.8. |t Vaccine Clinical Trials -- |g 7.9. |t QT Studies -- |g 7.10. |t Discussion -- |g pt. III |t ANALYSIS OF CLINICAL DATA -- |g 8. |t Analysis of Continuous Data -- |g 8.1. |t Introduction -- |g 8.2. |t Estimation -- |g 8.3. |t Test Statistics -- |g 8.4. |t Analysis of Variance -- |g 8.5. |t Analysis of Covariance -- |g 8.6. |t Nonparametric Methods -- |g 8.7. |t Repeated Measures -- |g 8.8. |t Discussion -- |g 9. |t Analysis of Categorical Data -- |g 9.1. |t Introduction -- |g 9.2. |t Statistical Inference for One Sample -- |g 9.3. |t Inference of Independent Samples -- |g 9.4. |t Ordered Categorical Data -- |g 9.5. |t Combining Categorical Data -- |g 9.6. |t Model-Based Methods -- |g 9.7. |t Repeated Categorical Data -- |g 9.8. |t Discussion -- |g 10. |t Censored Data and Interim Analysis -- |g 10.1. |t Introduction -- |g 10.2. |t Estimation of the Survival Function -- |g 10.3. |t Comparison Between Survival Functions -- |g 10.4. |t Cox's Proportional Hazard Model -- |g 10.5. |t Calendar Time and Information Time -- |g 10.6. |t Group Sequential Methods -- |g 10.7. |t Discussion -- |g 11. |t Sample Size Determination -- |g 11.1. |t Introduction -- |g 11.2. |t Basic Concept -- |g 11.3. |t Two Samples -- |g 11.4. |t Multiple Samples -- |g 11.5. |t Censored Data -- |g 11.6. |t Dose-Response Studies -- |g 11.7. |t Crossover Designs -- |g 11.8. |t Equivalence and Noninferiority Trials -- |g 11.9. |t Multiple-Stage Design in Cancer Trials -- |g 11.10. |t Multinational Trials -- |g 11.11. |t Comparing Variabilities -- |g 11.12. |t Discussion -- |g pt. IV |t ISSUES IN EVALUATION -- |g 12. |t Issues in Efficacy Evaluation -- |g 12.1. |t Introduction -- |g 12.2. |t Baseline Comparison -- |g 12.3. |t Intention-to-Treat Principle and Efficacy Analysis -- |g 12.4. |t Adjustment for Covariates -- |g 12.5. |t Multicenter Trials -- |g 12.6. |t Multiplicity -- |g 12.7. |t Data Monitoring -- |g 12.8. |t Use of Genetic Information for Evaluation of Efficacy -- |g 12.9. |t Sample Size Reestimation -- |g 12.10. |t Discussion -- |g 13. |t Safety Assessment -- |g 13.1. |t Introduction -- |g 13.2. |t Extent of Exposure -- |g 13.3. |t Coding of Adverse Events -- |g 13.4. |t Analysis of Adverse Events -- |g 13.5. |t Analysis of Laboratory Data -- |g 13.6. |t Analysis of QT/QTc Prolongation -- |g 13.7. |t Discussion -- |g pt. V |t RECENT DEVELOPMENT -- |g 14. |t Biomarkers and Targeted Clinical Trials -- |g 14.1. |t Introduction -- |g 14.2. |t Concepts and Strategies -- |g 14.3. |t Biomarker Development and Validation -- |g 14.4. |t Designs of Targeted Clinical Trials -- |g 14.5. |t Analyses of Targeted Clinical Trials -- |g 14.6. |t Discussion -- |g 15. |t Trials for Evaluating Accuracy of Diagnostic Devices -- |g 15.1. |t Introduction -- |g 15.2. |t Study Design -- |g 15.3. |t Measures of Diagnostic Accuracy -- |g 15.4. |t Reporting Results -- |g 15.5. |t Sample Size Estimation -- |g 15.6. |t Discussion -- |g 16. |t Statistical Methods in Translational Medicine -- |g 16.1. |t Introduction -- |g 16.2. |t Biomarker Development -- |g 16.3. |t Bench-to-Bedside -- |g 16.4. |t Animal Model Versus Human Model -- |g 16.5. |t Translation in Study Endpoints -- |g 16.6. |t Bridging Studies -- |g 16.7. |t Discussion -- |g 16.8. |t Appendix -- |g 17. |t Adaptive Clinical Trial Designs -- |g 17.1. |t Introduction -- |g 17.2. |t What Is Adaptive Design? -- |g 17.3. |t Well-Understood and Less Well-Understood Designs -- |g 17.4. |t Clinical/Statistical and Regulatory Perspectives -- |g 17.5. |t Impact of Protocol Amendments -- |g 17.6. |t Challenges in By-Design Adaptations -- |g 17.7. |t Obstacles of Retrospective Adaptations -- |g 17.8. |t Discussion -- |g 18. |t Traditional Chinese Medicine -- |g 18.1. |t Introduction -- |g 18.2. |t Fundamental Differences -- |g 18.3. |t Basic Considerations of TCM Clinical Trials -- |g 18.4. |t Other Issues in TCM Research and Development -- |g 18.5. |t Consortium for Globalization of Traditional Chinese Medicine -- |g 18.6. |t Discussion -- |g pt. VI |t CONDUCT OF CLINICAL TRIALS -- |g 19. |t Preparation and Implementation of a Clinical Protocol -- |g 19.1. |t Introduction -- |g 19.2. |t Structure and Components of a Protocol -- |g 19.3. |t Points to be Considered and Common Pitfalls During Development and Preparation of a Protocol -- |g 19.4. |t Common Departures for Implementation of a Protocol -- |g 19.5. |t Monitoring, Audit, and Inspection -- |g 19.6. |t Quality Assessment of a Clinical Trial -- |g 19.7. |t Discussion -- |g 20. |t Data Management of a Clinical Trial -- |g 20.1. |t Introduction -- |g 20.2. |t Regulatory Requirements -- |g 20.3. |t Development of Case Report Forms -- |g 20.4. |t Database Development -- |g 20.5. |t Data Entry, Query, and Correction -- |g 20.6. |t Data Validation and Quality -- |g 20.7. |t Database Lock, Archive, and Transfer -- |g 20.8. |t Critical Issues. |
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Clinical trials |x Methodology. | |
| 650 | 0 | |a Clinical trials |x Statistical methods. | |
| 650 | 2 | |a Clinical Trials as Topic |x methods | |
| 650 | 2 | |a Research Design | |
| 650 | 6 | |a Études cliniques |x Méthodologie. | |
| 650 | 6 | |a Études cliniques |x Méthodes statistiques. | |
| 650 | 7 | |a HEALTH & FITNESS |x Holism. |2 bisacsh | |
| 650 | 7 | |a HEALTH & FITNESS |x Reference. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Alternative Medicine. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Atlases. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Essays. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Family & General Practice. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Holistic Medicine. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Osteopathy. |2 bisacsh | |
| 650 | 7 | |a Clinical trials |x Methodology |2 fast | |
| 650 | 7 | |a Clinical trials |x Statistical methods |2 fast | |
| 700 | 1 | |a Liu, Jen-pei, |d 1952- |1 https://id.oclc.org/worldcat/entity/E39PBJgd643vC6Y4JQjTfwTPwC | |
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