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Oncology Clinical Trials - Successful Design, Conduct, and Analysis (Hardcover, 2nd Revised edition)
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Oncology Clinical Trials - Successful Design, Conduct, and Analysis (Hardcover, 2nd Revised edition)
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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 five 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
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