Randomized clinical trials: design, practice, and reporting

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 trials arise; 1.8 Ethical considerations; 1.9 Regulatory requirements; 1.10 Focus; 1.11 Further reading. -- 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. -- 3 The Trial Protocol: 3.1 Introduction; 3.2 Protocol - abstract; 3.3 Protocol - background; 3.4 Protocol - research objectives; 3.5 Protocol - design; 3.6 Protocol - intervention details; 3.7 Protocol - eligibility; 3.8 Protocol - randomization; 3.9 Protocol - assessment and data collection; 3.10 Protocol - statistical considerations; 3.11 Protocol - ethical issues; 3.12 Protocol - organizational structure; 3.13 Protocol - publication policy; 3.14 Protocol - trial forms; 3.15 Protocol - appendices; 3.16 Regulatory requirements; 3.17 Guidelines; 3.18 Protocols. -- 4 Measurement and Data Capture: 4.1 Introduction; 4.2 Measures and endpoints; 4.3 Making the observations; 4.4 Baseline measures; 4.5 Types of measures; 4.6 Data recording; 4.7 Technical notes; 4.8 Guidelines. -- 5 Randomization: 5.1 Introduction; 5.2 Rationale; 5.3 Mechanics; 5.4 Application; 5.5 Carrying out randomization; 5.6 Documentation; 5.7 Unacceptable methods; 5.8 Software; 5.9 Guidelines. -- 6 Trial Initiation: 6.1 Introduction; 6.2 Trial organization; 6.3 Data collection and processing; 6.4 Data monitoring; 6.5 Ethical and regulatory requirements; 6.6 Launching the trial; 6.7 Trial registries; 6.8 Guidelines. -- 7 Trial Conduct: 7.1 Introduction; 7.2 Regular feedback; 7.3 Publicity; 7.4 Data monitoring committees; 7.5 Protocol modifications; 7.6 Preparing the publication(s); 7.7 The next trial?; 7.8 Protocols. -- 8 Basics of Analysis. 8.1 Introduction; 8.2 Confidence intervals; 8.3 Statistical tests; 8.4 Examples of analysis; 8.5 Other issues; 8.6 Practice; 8.7 Technical details. -- 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 Other methods and software; 9.8 Guideline. -- 10 Reporting: 10.1 Introduction; 10.2 Publication guidelines; 10.3 Responsibilities; 10.4 Background; 10.5 Methods; 10.6 Findings; 10.7 When things go wrong; 10.8 Conclusions; 10.9 Guidelines. -- 11 Adaptations of the Basic Design: 11.1 Introduction; 11.2 Repeated measures; 11.3 Cluster-randomized trials; 11.4 Non-inferiority trials; 11.5 Guidelines. -- 12 Paired Designs: 12.1 Cross-over trials; 12.2 Split-mouth designs; 12.3 Paired organs. -- 13 More Than Two Interventions: 13.1 Introduction; 13.2 Unstructured comparisons; 13.3 Comparisons with placebo (or standard); 13.4 Dose response designs; 13.5 Factorial trials. -- 14 Further Topics: 14.1 Introduction; 14.2 Adaptive approaches; 14.3 Large simple trials; 14.4 Bayesian methods; 14.5 Zelen randomized-consent designs; 14.6 Systematic overviews; 14.7 Conclusion.

Using examples and case studies from industry, academia and research literature, provides a detailed overview of the key issues involved in designing, conducting, analysing and reporting randomized clinical trials. It examines the methodology for conducting Phase III clinical trials, developing the protocols, the practice for capturing, measuring, and analysing the resulting clinical data and their subsequent reporting. Are the principal method for determining the relative efficacy and safety of alternative treatments, interventions or medical devices. They are conducted by groups comprising one or more of pharmaceutical and allied health-care organisations, academic institutions, and charity supported research groups. In many cases such trials provide the key evidence necessary for the regulatory approval of a new product for future patient use. Provides comprehensive coverage of such trials, ranging from elementary to advanced level. Is an authoritative guide for clinicians, nurses, data managers and medical statisticians involved in clinical trials research and for health care professionals directly involved in patient care in a clinical trial context. [editor].