Planning and Analyzing Clinical Trials with Composite Endpoints
This book addresses the most important aspects of how to plan and evaluate clinical trials with a composite primary endpoint to guarantee a clinically meaningful and valid interpretation of the results. Composite endpoints are often used as primary effica
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Geraldine Rauch Svenja Schüler Meinhard Kieser
Planning and Analyzing Clinical Trials with Composite Endpoints
Springer Series in Pharmaceutical Statistics Editors F. Bretz P. Müller T. Permutt J. Pinheiro
More information about this series at http://www.springer.com/series/15122
Geraldine Rauch • Svenja SchRuler • Meinhard Kieser
Planning and Analyzing Clinical Trials with Composite Endpoints
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Geraldine Rauch Institute of Biometry and Clinical Epidemiology Charité - UniversitRatsmedizin Berlin Berlin, Germany
Svenja SchRuler Institute of Medical Biometry and Informatics University of Heidelberg Heidelberg, Germany
Meinhard Kieser Institute of Medical Biometry and Informatics University of Heidelberg Heidelberg, Germany
ISSN 2366-8695 ISSN 2366-8709 (electronic) Springer Series in Pharmaceutical Statistics ISBN 978-3-319-73769-0 ISBN 978-3-319-73770-6 (eBook) https://doi.org/10.1007/978-3-319-73770-6 Library of Congress Control Number: 2017964233 Mathematics Subject Classification (2010): 62L05, 62P10 © Springer International Publishing AG, part of Springer Nature 2017 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. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Printed on acid-free paper This Springer imprint is published by the registered company Springer International Publishing AG part of Springer Nature. The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
We would like to thank our colleagues from the Institute of Medical Biometry and Informatics, University of Heidelberg, for many discussions on the topic of composite endpoints and for reviewing parts of the text, especially Eva Dölger, Ann-Kathrin Ozga, and Stella Preussler. In addition, we are grateful to Springer Publishers for the decision to publish this book. A special thanks goes to our editor Dr. Eva Hiripi for her continuous encouragement and support for this project.
Preface
Composite endpoints
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