Clinical Trials, Second Edition provides a straightforward and authoritative presentation of statistical methods for clinical trials.

Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of:

• planning the experiment
• assembling a study cohort
• assessing data
• reporting results

Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides commonsense solutions.

Coverage of the Second Edition ranges from statistical principles to controversial topics, including alternative medicine and ethics. It offers pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct.

Contents

1. Preliminaries
2. Clinical Trails as Research
3. Why Clinical Trials Are Ethical
4. Contexts for Clinical Trials
5. Statistical Perspectives
6. Clinical Trials as Experimental Designs
7. Random Error and Bias
8. Objectives and Outcomes
9. Translational Clinical Trials
10. Dose Finding Designs
11. Sample Size and Power
12. The Study Cohort
13. Treatment Allocation
14. Treatment Effects Monitoring
15. Counting Patients and Events
16. Estimating Clinical Effects
17. Prognostic Factor Analyses
18. Reporting and Authorship
19. Factorial Designs
20. Cross-Over Designs
21. Meta-Analyses
22. Misconduct and Fraud in Clinical Research

Appendices

• Data and Programs
• Notation and Terminology
• Abbreviations
• Nuremberg Code
• Declaration of Helsinki
• NCI Data and Safety Monitoring Policy
• NIH Data and Safety Monitoring Policy
• Royal Statistical Society Code of Conduct

Index

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