Oncology Clinical Trials, 2nd Edition

Clinical trials are the engine of progress in the development of new drugs, procedures, and devices for the detection, monitoring, prevention, and treatment of cancer. A well-conceived, carefully designed, and efficiently conducted clinical trial can produce results that change clinical practice, deliver new oncology drugs, interventions, and diagnostics to the marketplace, and expand our understanding of cancer biology. This book presents 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. It provides 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. The book provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. It covers various topics such as 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. The book is organized into six parts containing 49 chapters. The first part provides background and introduction to oncology clinical trials which includes ethical principles guiding clinical research. The next two parts discusses designing and conducting oncology clinical trials such as phase I, II and III trials; confirmatory clinical trials, noninferiority trials, and quality of life studies. The fourth part describes analyzing results of oncology clinical trials. The fifth part talks about special considerations in oncology clinical trials. The final part discusses about cooperative groups, regulatory, and governing bodies involved in oncology clinical trials.