Preface to the First Edition.
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.
22. Misconduct and Fraud in Clinical Research.
Appendix A: Data and Programs.
Appendix B: Notation and Terminology.
Appendix C: Abbreviations.
Appendix D: Nuremberg Code.
Appendix E: Declaration of Helsinki.
Appendix F: NCI Data and Safety Monitoring Policy.
Appendix G: NIH Data and Safety Monitoring Policy.
Appendix H: Royal Statistical Society Code of Conduct.
"…a very good addition to the clinical trials area." (Statistical Methods in Medical Research, October 2006)
"…an excellent reference for both clinicians and statisticians." (Journal of Biopharmaceutical Statistics, May/June 2006)
- Covers vital design considerations
- Emphasizes experimental designs to search for treatment advances
- Focuses on concepts that unify
- Explores areas of controversy such as ethics (now greatly expanded) and offers pragmatic information regarding allegations of fraud or misconduct
- Includes summaries, revised discussion questions, and updated references in each chapter
- Accompanied by an ftp site, dozens of new, redrawn, and/or updated illustrations, a comprehensive bibliography, and multiple indexes
- Incorporates new content, including new chapters on contexts, perspectives, transitional trials, and early developmental drug design
- Now, extensively class-tested