| Document Type
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BL
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| Record Number
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1025621
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| Doc. No
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b779991
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| Title & Author
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Oncology clinical trials /\ [edited by] Wm. Kevin Kelly, Susan Halabi.
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| Publication Statement
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New York :: Demos Medical,, ©2010.
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| Page. NO
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1 online resource (xvii, 377 pages) :: illustrations, map
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| ISBN
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1282552201
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: 1933864389
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: 1935281763
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: 6612552204
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: 9781282552203
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: 9781933864389
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: 9781935281764
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: 9786612552205
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9781933864389
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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Foreword; Preface; Contributors; 1. Introduction: What Is a Clinical Trial?; 2. Historical Perspectives of Oncology Clinical Trials; 3. Ethical Principles Guiding Clinical Research; 4. Preclinical Drug Assessment; 5. Formulating the Question and Objectives; 6. Choice of Endpoints in Cancer Clinical Trials; 7. Design, Testing, and Estimation in Clinical Trials; 8. Design of Phase I Trials; 9. Design of Phase II Trials; 10. Randomization; 11. Design of Phase III Trials; 12. Multiple Treatment Arm Trials; 13. Noninferiority Trials in Oncology; 14. Bayesian Designs in Clinical Trials
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15. The Trials and Tribulations of Writing an Investigator Initiated Clinical Study16. Data Collection; 17. Reporting of Adverse Event; 18. Toxicity Monitoring: Why, What, When?; 19. Interim Analysis of Phase III Trials; 20. Interpretation of Results: Data Analysis and Reporting of Results; 21. Statistical Considerations for Assessing Prognostic Factors in Cancer; 22. Pitfalls in Oncology Clinical Trial Designs and Analysis; 23. Biomarkers and Surrogate Endpoints in Clinical Trials; 24. Use of Genomics in Therapeutic Clinical Trials; 25. Imaging in Clinical Trials
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26. Pharmacokinetic and Pharmacodynamic Monitoring in Clinical Trials: When Is It Needed?27. Practical Design and Analysis Issues of Health Related Quality of Life Studies in International Randomized Controlled Cancer Clinical Trials; 28. Clinical Trials Considerations in Special Populations; 29. A Critical Reader's Guide to Cost-Effectiveness Analysis; 30. Systemic Review and Meta-Analysis; 31. Regulatory Affairs: The Investigator-Initiated Oncology Trial; 32. The Drug Evaluation Process in Oncology: FDA Perspective; 33. Industry Collaboration in Cancer Clinical Trials
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34. Defining the Roles and Responsibilities of Study Personnel35. Writing a Consent Form; 36. How Cooperative Groups Function; 37. Adaptive Clinical Trial Design in Oncology; 38. Where Do We Need to Go with Clinical Trials in Oncology?; Index
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| Abstract
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Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical.
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| Subject
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Cancer-- Research-- Statistical methods.
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Clinical trials.
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Cancer-- Research-- Statistical methods.
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Clinical trials.
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HEALTH FITNESS-- Diseases-- Cancer.
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Neoplasms-- drug therapy.
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| Subject
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Clinical Trials as Topic.
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| Dewey Classification
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362.196/994061
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| LC Classification
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RC267.O53 2010eb
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| NLM classification
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2010 D-288
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QZ 267O578 2010
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| Added Entry
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Halabi, Susan.
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Kelly, Wm. Kevin, (William Kevin)
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