CHAPTER 7: Trial Conduct and Completion
7.1 Introduction
7.2 Regular feedback
7.3 Publicity
7.4 Protocol modifications
7.5 Preparing the publication(s)
7.6 The next trial?
7.7 Protocol
CHAPTER 8: Basics for Analysis
8.1 Introduction
8.2 The standard Normal distribution
8.3 Confidence intervals
8.4 Statistical tests
8.5 Examples of analysis
8.6 Regression methods
8.7 Other issues
8.8 Practice
8.9 Technical details
CHAPTER 9: Trial Size
9.1 Introduction
9.2 Significance level and power
9.3 The fundamental equation
9.4 Specific situations
9.5 Practical considerations
9.6 Further topics
9.7 Guideline
9.8 Software
CHAPTER 10: Data and Safety Monitoring
10.1 Introduction
10.2 The DSMB
10.3 Early reviews
10.4 Interim reviews
10.5 Protocols
CHAPTER 11: Reporting
11.1 Introduction
11.2 Publication
11.3 Responsibilities
11.4 Background
11.5 Methods
11.6 Findings
11.7 When things go wrong
11.8 Conclusions
11.9 Guidelines
7 PART II: Adaptions of the Basic Design CHAPTER 12: More Than Two Interventions 12.1 Introduction 12.2 Unstructured comparisons 12.3 Comparisons with placebo (or standard) 12.4 Dose–response designs 12.5 Factorial trials 12.6 Complex structure comparisons CHAPTER 13: Paired and Matched Designs 13.1 Matched‐pair trials 13.2 Cross‐over trials 13.3 Split‐mouth designs 13.4 Guidelines CHAPTER 14: Repeated Measures Design 14.1 Introduction 14.2 Simplified analysis 14.3 Regression models 14.4 Auto‐correlation 14.5 Accounting for auto‐correlation 14.6 The design effect (DE) 14.7 Trial size 14.8 Practicalities 14.9 Reporting 14.10 Matched organs receiving the same intervention CHAPTER 15: Non‐Inferiority and Equivalence Trials 15.1 Introduction 15.2 Non‐inferiority 15.3 Analysis 15.4 Trial size 15.5 Equivalence 15.6 Reporting 15.7 Practical Issues 15.8 Guidelines CHAPTER 16: Cluster Designs 16.1 Design features 16.2 Procedures 16.3 Regression models 16.4 Intra‐class correlation
