Randomised Clinical Trials. Design, Practice and Reporting

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

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 of randomised 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.

ABOUT THE AUTHOR

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 Fayers, Institute of Applied Health, University of Aberdeen, Scotland, 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.