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Clinical Trials


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Table of Contents

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.

About the Author

STEVEN PIANTADOSI, MD, Phd, is Professor of Oncology and Director of Biostatistics at the Johns Hopkins Oncology Center. He also holds appointments in the Departments of Biostatistics and Epidemiology at the Bloomberg School of Public Health at John Hopkins University. Dr. Piantadosi has taught clinical trials for seventeen years and is the author or coauthor of more than 250 scholarly articles.


"?clearly written, practical presentations of the standard topics, and also fascinating discussion you won't find elsewhere?" (Journal of Clinical Research Best Practices, August 2007) "?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)

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