The 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 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 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
The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research.
Ultimately, the cancer patients will be benefited. "Clinical trials remain the most important vehicle for improving the care of cancer patients. This text presents the fundamental components and challenges involving clinical investigations.
... S.V., Mantel, N., McPherson, K., Peto, J., and Smith, P.G., Design and analysis of randomized clinical trials requiring prolonged observation of each patient, I. Introduction and design, British Journal of Cancer, 34:585–612, 1976.
Peto R., Pike M. C., Armitage P., Breslow N. E., Cox D. R., Howard S. V., Mantel N., McPherson K., Peto I., and Smith P. G. Design and analysis of randomized clinical trials requiring prolonged observation of each patient.
The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies.
This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology.
"Cancer on Trial"answers these questions by exploring how practitioners established a new style of practice, at the center of which lies the cancer clinical trial."
Implementing a National Cancer Clinical Trials System for the 21st Century is a summary of that workshop.
Breakthrough therapy designation was enacted on July 9, 2012, with the ratification of the Food and Drug Administration Safety and Innovation Act (FDASIA). Section 902 of FDASIA provides the two general criteria for a drug to receive ...
Suitable for cancer clinicians and biostatisticians, this book shows how randomized phase II trials with a prospective control resolve the shortcomings of traditional single-arm phase II trials.