Oncology Clinical Trials: Successful Design, Conduct, and Analysis, Second Edition – Oncology Clinical Trials Book for Designing, Conducting and($150.18Value)

Description

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 William Kevin Kelly, DO , is Professor of Medical Oncology and Urology at Thomas Jefferson University. He currently serves as the Chair of the Department of Medical Oncology at Thomas Jefferson University and research advisor to the Cancer Center Director at the Sidney Cancer Comprehensive Cancer Center.  He has also served in many leadership roles in the National Clinical Trials Network and was a member of the FDAs Oncology Drug Advisor Committee.  His expertise is in drug and biomarker development and trial design/implementation in prostate and bladder cancer. He has been instrumental in defining the use of many novel therapies and biomarkers in patients with prostate and bladder cancer for all stages of these diseases.    Susan Halabi, PhD is the James B. Duke Distinguished Professor of Biostatistics and Bioinformatics and Co-Chief of the Division of Biostatistics in the Department of Biostatistics and Bioinformatics at Duke University Medical Center. For more than twenty-five years, she has been a leading authority in the design and analysis of oncology clinical trials. Dr. Halabi develops innovative statistical methods for clinical research, including novel variable selection techniques for biomarkers and high-dimensional data. Dr. Halabi is a past president of the Society for Clinical Trials and a former member of the FDA Oncology Drugs Advisory Committee. She is the recipient of several prestigious awards and is a Fellow of the Society for Clinical Trials, the American Statistical Association, and the American Society for Clinical Oncology.