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Clinical Trials
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Learn rigorous statistical methods to ensure valid clinical trials This Second Edition of the critically hailed Clinical Trials builds on the text's reputation as 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, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides commonsense solutions. The author bases the revisions and updates on his own classroom experience, as well as feedback from students, instructors, and medical and statistical professionals involved in clinical trials. The Second Edition greatly expands its coverage, ranging from statistical principles to controversial topics, including alternative medicine and ethics. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First Edition will discover completely new chapters, including: Contexts for clinical trials Statistical perspectives Translational clinical trials Dose-finding and dose-ranging designs Each chapter is accompanied by a summary to reinforce the key points. Revised discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge, and updated references are provided to direct readers to the most recent literature. This text distinguishes itself with its accessible and broad coverage of statistical design methods--the crucial building blocks of clinical trials and medical research. Readers learn to conduct clinical trials that produce valid qualitative results backed by rigorous statistical methods.
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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.

Reviews

"...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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