Oncology Clinical Trials: Successful Design, Conduct and Analysis

Susan Halabi · William Kevin Kelly

Dec 2009 · Demos Medical Publishing

Ebook

168

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About this ebook

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

About the author

Susan Halabi, PhD is the James B. Duke Distinguished Professor of Biostatistics and Bioinformatics and Co-Chief of the Division of Biostatistics in the Department of Biostatistics and Bioinformatics at Duke University Medical Center. For more than twenty-five years, she has been a leading authority in the design and analysis of oncology clinical trials. Dr. Halabi develops innovative statistical methods for clinical research, including novel variable selection techniques for biomarkers and high-dimensional data. Dr. Halabi is a past president of the Society for Clinical Trials and a former member of the FDA Oncology Drugs Advisory Committee. She is the recipient of several prestigious awards and is a Fellow of the Society for Clinical Trials, the American Statistical Association, and the American Society for Clinical Oncology.

William Kevin Kelly, DO, is Professor of Medical Oncology and Urology at Thomas Jefferson University. He currently serves as the Chair of the Department of Medical Oncology at Thomas Jefferson University and research advisor to the Cancer Center Director at the Sidney Cancer Comprehensive Cancer Center. He has also served in many leadership roles in the National Clinical Trials Network and was a member of the FDAs Oncology Drug Advisor Committee. His expertise is in drug and biomarker development and trial design/implementation in prostate and bladder cancer. He has been instrumental in defining the use of many novel therapies and biomarkers in patients with prostate and bladder cancer for all stages of these diseases.

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

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