Fundamentals of Clinical Trials
This is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the thir
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Lawrence M. Friedman • Curt D. Furberg David L. DeMets
Fundamentals of Clinical Trials Fourth Edition
Lawrence M. Friedman Bethesda, MD USA [email protected]
Curt D. Furberg Wake Forest University School of Medicine Winston-Salem, NC USA [email protected]
David L. DeMets Department of Biostatistics & Medical Informatics University of Wisconsin Madison, WI USA [email protected]
ISBN 978-1-4419-1585-6 e-ISBN 978-1-4419-1586-3 DOI 10.1007/978-1-4419-1586-3 Springer New York Dordrecht Heidelberg London Library of Congress Control Number: 2010933512 © Springer Science + Business Media, LLC 2010 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. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)
Preface
The clinical trial is “the most definitive tool for evaluation of the applicability of clinical research.” It represents “a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments” [1]. It has been called on many occasions, “the gold standard” against which all other clinical research is measured. Although many clinical trials are of high quality, a careful reader of the medical literature will notice that a large number have deficiencies in design, conduct, analysis, presentation, and/or interpretation of results. Improvements have occurred over the past few decades, but too many trials are still conducted without adequate attention to its fundamental principles. Certainly, numerous studies could have been upgraded if the authors had had a better understanding of the fundamentals. Since the publication of the first edition of this book, a large number of other texts on clinical trials have appeared, most of which are indicated here [2–21]. Several of them, however, discuss only specific issues involved in clinical trials. Additionally, many are no longer current. The purpose of this fourth edition is to update areas in which major progress has been made since the publication of the third edition. We have revised most chapters considerably and added one on ethical issues. In this book, we hope to assist investigators in improving the quality of clinical trials by discussing fundamental concepts with examples from our experience and the literature. The book is intended both for investigato
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