Oncology Clinical Trials: A Comprehensive Guide to Design, Conduct, and Analysis

The second edition of Oncology Clinical Trials is a thoroughly revised and updated version that provides the latest designs and methods for conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents. This book is divided into six sections and offers expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field.

Key Features of the Second Edition

This edition includes:

• Examples of real-life flaws and real-world examples for how to successfully design, conduct, and analyze quality clinical trials and interpret them.
• Chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives.
• A comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology.
• 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.
• 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.
• Comprehensive coverage of all regulatory aspects in the pursuit of global oncology trials.

Why This Book Matters

Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. This book is essential for oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives who want to design, conduct, and analyze quality clinical trials and interpret them effectively.