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
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