Clinical Trials – A Methodologic Perspective 2e - Bookswagon
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Clinical Trials – A Methodologic Perspective 2e

Clinical Trials – A Methodologic Perspective 2e


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About the Book

The previous edition of this title has an excellent track record, and its continued comprehensive coverage is unparalleled by the competition. The author, who is renowned throughout the world, has significantly and thoroughly refined and retooled this edition. This updated volume continues its straightforward, authoritative review of basic statistical methods for clinical trials. Even though numerous books have appeared on the subject matter, very few of them, except for this title, emphasize accessible coverage of statistical methods - the crucial building blocks of medical research. The author's hands-on approach, embracing a number of different trial designs and clinical fields, guides readers through the process of planning an experiment, putting together a study cohort, assessing data, and reporting results, and addresses the problems that are likely to confront any such study. Paramount throughout is the effort to strike a common ground between qualitative clinical and rigorous statistical methods. It covers vital design considerations; and emphasizes experimental designs to search for treatment advances. It 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. It includes summaries, revised discussion questions, and updated references in each chapter. It is accompanied by an ftp site, dozens of new, redrawn, and/or updated illustrations, a comprehensive bibliography, and multiple indexes. It incorporates new content, including new chapters on contexts, perspectives, transitional trials, and early developmental drug design.

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.

Review :
"...an excellent reference for both clinicians and statisticians." (Journal of Biopharmaceutical Statistics, May/June 2006)


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Product Details
  • ISBN-13: 9780471740131
  • Publisher: John Wiley and Sons Ltd
  • Publisher Imprint: John Wiley & Sons Inc
  • Language: English
  • Weight: 10 gr
  • ISBN-10: 0471740136
  • Publisher Date: 01 Jul 2005
  • Binding: Other digital
  • No of Pages: 720


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