A carefully designed and efficiently conducted phase III clinical trial can produce results that can change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. The second edition of “Oncology Clinical Trials: Successful Design, Conduct, and Analysis” was recently published and 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.
The first edition, a bestseller, is considered the gold standard reference on oncology clinical trials in the field; and the second edition continues to provide examples of real-life flaws and real-world trials for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by 137 collaborators from 45 institutions including medical oncologists, biostatisticians, clinical research administrators, and industry and regulatory representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology.
This updated version includes background and expert guidance governing oncology clinical trials and innovative statistical design and analysis permeating the field. Chapter topics range from conducting trials in a safe and effective manner and analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. “The purpose of this book is to train the next generation of clinical trialists in oncology. As with the first edition, this updated volume addresses practical issues that researchers encounter in conducting and designing clinical trials, underscoring the challenges, failures and successes inherent to the process. We are pleased to once again offer all royalties from this book to the American Society of Clinical Oncology to train Young Investigators” said Dr. Halabi.
The book was edited by Professor Susan Halabi, PhD and Wm. Kevin Kelly, DO, Professor, Medical Oncology and Urology and Director, Division of Solid Tumor Oncology -Sidney Kimmel Medical College at Thomas Jefferson University, Associate Director of Clinical Research.