Randomised Clinical Trials: Design, Practice and Reporting provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process.
This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book:
* Provides comprehensive coverage ofrandomised clinical trials, ranging from basic to advanced
* Features several new chapters, updated case studies and examples, and references to changes in regulations
* Explains basic randomised trials, including the parallel two-group controlled trial with a single outcome measure
* Covers paired trial designs and trials with more than two interventions
* Includes a chapter on miscellaneous topics such as adaptive designs, large simple trials, Bayesian methods for very small trials, alpha-spending functions and the predictive probability test
Randomised Clinical Trials is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.
สารบัญ
Preface
Part I Basic considerations
1. Introduction
2. Design Features
3. The Trial Protocol
4. Measurement and Data Capture
5. Randomisation
6. Trial Initiation
7. Trial Conduct and Completion
8. Basics for Analysis
9. Trial Size
10. Data and Safety Monitoring
11. Reporting
Part II Adaptions of the Basic Design
12. More than Two Interventions
13. Paired and Matched Designs
14. Repeated Measures Design
15. Non-Inferiority and Equivalence Trials
16. Cluster Designs
17. Stepped Wedge Designs
Part III Further topics
18. Genomic Targets
19. Feasibility and Pilot Studies
20. Further Topics
Statistical Tables
Glossary
References
Index
เกี่ยวกับผู้แต่ง
David Machin, Leicester Cancer Research Group, University of Leicester, UK; and Medical Statistics Group, School of Health and Related Research, University of Sheffield, UK.
Peter M. Fayers, Institute of Applied Health, University of Aberdeen, UK.
Bee Choo Tai, Saw Swee Hock School of Public Health, National University of Singapore, and National University Health System, Singapore; and Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, Singapore.
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