Principles of Anticancer Drug Development
A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.
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Principles of Anticancer Drug Development Edited by
Manuel Hidalgo, MD, PhD Universidad CEU San Pablo, Spain
S. Gail Eckhardt, MD University of Colorado at Denver, USA
Elizabeth Garrett-Mayer, PhD Medical University of South Carolina, South Carolina, USA
Neil J. Clendeninn, MD, PhD CANAID, Inc., Hanalei, USA
Editors Manuel Hidalgo, MD, PhD Department of Oncology School of Medicine CEU San Pablo University Madrid, Spain and Centro Integral Oncológico Clara Campal (CIOCC) Madrid, Spain and Gastrointestinal Clinical Research Unit Centro Integral Investigaciones Oncológicas (CNIO) C/ Melchor Fernández Almagro 3 Madrid, Spain [email protected]
S. Gail Eckhardt, MD Professor and Division Head, Medical Oncology Stapp Harlow Chair in Cancer Research University of Colorado at Denver Aurora, CO 80045 USA [email protected] Elizabeth Garrett-Mayer, PhD Hollings Cancer Center Medical University of South Carolina Charleston, SC 29425 USA [email protected] Neil J. Clendeninn, MD, PhD CANAID, Inc Drug Development Consultant 96714 Hanalei USA [email protected]
ISBN 978-1-4419-7357-3 e-ISBN 978-1-4419-7358-0 DOI 10.1007/978-1-4419-7358-0 Springer New York Dordrecht Heidelberg London © Springer Science+Business Media, LLC 2011 All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer Science+Business Media, LLC, 233 Spring Street, New York, NY 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in connection with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden. The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject to proprietary rights. While the advice and information in this book are believed to be true and accurate at the date of going to press, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)
Blurb A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.
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Preface The development of cancer drugs, from the preclinical studies to final randomized clinical trial is a science per se. The process involves multiples distinct steps and requires the participation of multiple individuals with unique expertise such as toxicologist, pharmacologists, pathologists, statisticians, clinicians and ethics and regulatory experts. In addition, it involves several different organizations suc
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