Group Sequential and Confirmatory Adaptive Designs in Clinical Trials
This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed
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Gernot Wassmer Werner Brannath
Group Sequential and Confirmatory Adaptive Designs in Clinical Trials
Springer Series in Pharmaceutical Statistics Editors F. Bretz P. MRuller T. Permutt J. Pinheiro
More information about this series at http://www.springer.com/series/15122
Gernot Wassmer • Werner Brannath
Group Sequential and Confirmatory Adaptive Designs in Clinical Trials
123
Gernot Wassmer University of Cologne Cologne, Germany
Werner Brannath University of Bremen Bremen, Germany
ISSN 2366-8695 ISSN 2366-8709 (electronic) Springer Series in Pharmaceutical Statistics ISBN 978-3-319-32560-6 ISBN 978-3-319-32562-0 (eBook) DOI 10.1007/978-3-319-32562-0 Library of Congress Control Number: 2016945375 © Springer International Publishing Switzerland 2016 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper This Springer imprint is published by Springer Nature The registered company is Springer International Publishing AG Switzerland
Preface
During the last two decades, there was an intensive discussion of a statistical methodology for clinical trials that generalized the use and conduct of interim analyses. Using a specific methodology, under control of the Type I error rate, it was made possible to redesign the trial for the forthcoming stages in relevant details including sample size, considered treatment arms, subgroups of patients, and others. The use of such multi-stage adaptive designs was introduced in an article by Peter Bauer entitled “Multi-stage testing with adaptive designs.” It appeared 1989 in the German journal Biometrie und Informatik in Medizin und Biologie. Especially the publication by Bauer and Köhne 1994 in Biometrics raised many controversial discussions. In the meantime, the underlying concept is regarded as a relevant and important generalization of the “classical” group sequential design methodology. It has even found its way into a reflection paper entitled “Methodological Issues in Confirmatory Clinical Trials Planned
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