Randomised Clinical Trials. David Machin
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 16.5 Trial size 16.6 Analysis