A Statistical Model for Risk-Based Monitoring of Clinical Trials

Risk-based monitoring allows monitors of clinical trial sites to focus their visits on sites with the greatest potential for risk reduction. Here we present a statistical model that recommends sites for the monitor to visit. The model makes use of a pre-v

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Jianchang Lin Bushi Wang Xiaowen Hu Kun Chen Ray Liu Editors

Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics Selected Papers from the 2015 ICSA/ Graybill Applied Statistics Symposium, Colorado State University, Fort Collins

ICSA Book Series in Statistics Series Editors Jiahua Chen Department of Statistics University of British Columbia Vancouver Canada Ding-Geng (Din) Chen University of North Carolina Chapel Hill, NC, USA

More information about this series at http://www.springer.com/series/13402

Jianchang Lin • Bushi Wang • Xiaowen Hu Kun Chen • Ray Liu Editors

Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics Selected Papers from the 2015 ICSA/Graybill Applied Statistics Symposium, Colorado State University, Fort Collins

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Editors Jianchang Lin Global Statistics Takeda Pharmaceuticals Cambridge, MA, USA

Bushi Wang Biostatistics Boehringer Ingelheim Pharmaceuticals Ridgefield, CT, USA

Xiaowen Hu Colorado State University Fort Collins, CO, USA

Kun Chen University of Connecticut Storrs, CT, USA

Ray Liu Global Statistics Takeda Pharmaceuticals Cambridge, MA, USA

ISSN 2199-0980 ICSA Book Series in Statistics ISBN 978-3-319-42567-2 DOI 10.1007/978-3-319-42568-9

ISSN 2199-0999 (electronic) ISBN 978-3-319-42568-9 (eBook)

Library of Congress Control Number: 2016954077 © 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 The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland

Preface

The 2015 Joint 24th International Chinese Statistical Association (ICSA) Applied Statistics Symposium and 13th Graybill Conference was successfully held from June 14 to June 17, 2015, in Fort Collins, Colorado, USA. The conference covers a variety of exciting and