Oncology Clinical Trials: Successful Design, Conduct and Analysis

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 contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial.

Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials.

Oncology Clinical Trials features:
A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology
Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives
Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis
Real-life examples from reported clinical trials included throughout
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Contents
Foreword; Preface; Acknowledgments; 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; 15. The Trials and Tribulations of Writing an Investigator Initiated Clinical Study; 16. 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; 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 Evolution Process in Oncology: FDA Perspective; 33. Industry Collaboration in Cancer Clinical Trials; 34. Defining the Roles and Responsibilities of Study Personnel; 35. Writing a Consent Form; 36. How Cooperative Groups Function; 37. Adaptive Design; 38. Where Do We Need to Go with Clinical Trials in Oncology?; Index
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About the Editors
Kevin Kelly, DO
Professor of Medical Oncology, Jefferson Medical College, Philadlephia, PA

Susan Halabi, PhD

Susan Halabi, PhD - Associate Professor, Department of Biostatistics and Bioinformatics, Duke University Medical Center.

Richard Schilsky, MD

Richard L. Schilsky, MD, Profesor of Medicine, University of Chicago, Chairman, Cancer and Leukemia Group B, ASCO President 2008-2009