Oncology Clinical Trials: Successful Design, Conduct, and Analysis, Edition 2
About this ebook
Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology.
NEW TO THIS EDITION:
- Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials
- Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more
- Comprehensively covers all regulatory aspects in the pursuit of global oncology trials
- Digital access to the ebook included
About the author
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.
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.
