Designs for Clinical Trials Perspectives on Current Issues
Statistical methods for clinical trials have been an area of active research in Biostatistics since the first modern clinical trials were mounted in 1946 by the British Medical Research Council in whooping cough and tuberculosis. Often, the particip
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For further volumes: http://www.springer.com/series/7616
David Harrington Editor
Designs for Clinical Trials Perspectives on Current Issues
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Editor David Harrington Dana-Farber Cancer Institute Boston, MA 02215 USA david [email protected]
ISBN 978-1-4614-0139-1 e-ISBN 978-1-4614-0140-7 DOI 10.1007/978-1-4614-0140-7 Springer New York Dordrecht Heidelberg London Library of Congress Control Number: 2011936525 c Springer Science+Business Media, LLC 2012 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)
Dedicated to the many patients who have participated in clinical trials, with special appreciation to the selfless contribution they have made to progress in the treatment and management of chronic diseases.
Preface
In 1998, R. Smith wrote that “The randomized clinical trial is the most important advance in scientific medicine in the twentieth century.” Smith’s view may surprise some of our clinical colleagues but is entirely defensible. Sequences of randomized trials have led to dramatic advances in chronic diseases such as breast cancer, childhood leukemia, HIV, cardiovascular disease, and many other areas. These and other diseases are biologically complex and, despite decades of research, still understood incompletely, at best. Adequately powered trials have led to the discovery of incremental advances that have cumulatively yielded substantial improvements in survival and disease control. The contributions to this volume examine some issues in clinical trial design that have received attention in recent years. The collection is intended primarily for the statistical practitioner, especially the very busy trialist whose active collaboration in cancer, HIV, cardiology, or other areas of medical research makes it difficult to find the time to stay abreast of advances in trial methodology. The contributors and I share the opinion that while the large majority of trials are well-designed and conducted, newer methods for design and analysis linger too long in the methodology literature before appearing in mainstream use. The principles of design used across the range of trials are necessarily diverse; the goals of a phase I safety study are very different from a careful assessment of patient self-reported quality of life in late phase
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