Clinical Trials : A Methodologic Perspective

Preface. Preface to the First Edition. 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. 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. Bibliography. Author Index. Subject Index.