Oncology Clinical Trials: Successful Design, Conduct, and Analysis 2nd Edition

Description of Oncology Clinical Trials

The new, updated second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents―including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities.

Now divided into six sections this revamped clinical trials book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials.

Considered by many as the gold standard reference on oncology and cancer clinical trials in the field, the newly updated second edition continues to provide examples of real-life flaws and real-world examples for how to successfully complete clinical trial 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.

Key features new to the updated edition include:

• 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, Department of Medical Oncology and Urology, Sidney Kimmel Medical College at Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, PA.

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

Read more about: William Kevin Kelly, Susan Halabi