Table of Contents
1 Cover
5 Preface
6
PART I: Basic Considerations
CHAPTER 1: Introduction
1.1 Introduction
1.2 Some completed trials
1.3 Choice of design
1.4 Practical constraints
1.5 Influencing clinical practice
1.6 History
1.7 How do trials arise?
1.8 Ethical considerations
1.9 Regulatory requirements
1.10 Focus
1.11 Further reading
CHAPTER 2: Design Features
2.1 Introduction
2.2 The research question
2.3 Patient selection
2.4 The consent process
2.5 Choice of interventions
2.6 Choice of design
2.7 Assigning the interventions
2.8 Making the assessments
2.9 Analysis and reporting
2.10 Technical details
2.11 Guidelines
2.12 Further reading
CHAPTER 3: The Trial Protocol
3.1 Introduction
3.2 Abstract
3.3 Background
3.4 Research objectives
3.5 Design
3.6 Intervention details
3.7 Eligibility
3.8 Randomisation
3.9 Assessment and data collection
3.10 Statistical considerations
3.11 Ethical issues
3.12 Organisational structure
3.13 Publication policy
3.14 Trial forms
3.15 Appendices
3.16 Regulatory requirements
3.17 Guidelines
3.18 Protocols
CHAPTER 4: Measurement and Data Capture
4.1 Introduction
4.2 Types of measures
4.3 Measures and endpoints
4.4 Making the observations
4.5 Baseline measures
4.6 Data recording
4.7 Technical notes
4.8 Guidelines
CHAPTER 5: Randomisation
5.1 Introduction
5.2 Rationale
5.3 Mechanics
5.4 Application
5.5 Carrying out randomisation
5.6 Documentation
5.7 Unacceptable methods
5.8 Guidelines
CHAPTER 6: Trial Initiation
6.1 Introduction
6.2 Trial organisation
6.3 Data collection and processing
6.4 Internal data monitoring
6.5 Ethical and regulatory requirements
6.6 Launching the trial
6.7 Trial registries
6.8 Guidelines
CHAPTER 7: Trial Conduct and Completion
7.1