Clinical Trials
This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and education
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Timothy M. Pawlik Julie A. Sosa Editors
Clinical Trials Second Edition
Success in Academic Surgery Series editors: Lillian Kao McGovern School The University of Texas Health Science Centre Houston, TX USA Herbert Chen Department of Surgery University of Alabama at Birmingham Birmingham, AL USA
More information about this series at http://www.springer.com/series/11216
Timothy M. Pawlik • Julie A. Sosa Editors
Clinical Trials Second Edition
Editors Timothy M. Pawlik Chair, Department of Surgery The Urban Meyer III and Shelley Meyer Chair for Cancer Research The Ohio State University Wexner Medical Columbus, OH USA
Julie A. Sosa Leon Goldman, MD Distinguished Professor of Surgery and Chair Department of Surgery University of California, San Francisco San Francisco, CA USA Professor, Department of Medicine
University of California, San Francisco San Francisco, CA USA
ISSN 2194-7481 ISSN 2194-749X (electronic) Success in Academic Surgery ISBN 978-3-030-35487-9 ISBN 978-3-030-35488-6 (eBook) https://doi.org/10.1007/978-3-030-35488-6 © Springer Nature Switzerland AG 2014, 2020 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, expressed 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. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
Contents
1 The History of Clinical Trials����������������������������������������������������������������� 1 Janice Hu, Justin Barr, and Georgia M. Beasley 2 Ethics (Informed Consent and Conflicts of Interest)���������������������������� 17 Kara K. Rossfeld, Jordan M. Cloyd, Elizabeth Palmer, and Timothy M. Pawlik 3 Generating a Testable Hypothesis and Underlying Principles of Clinical Trials �������������������������������������������������������������������� 33 Cecilia G. Ethun and Shishir K. Maithel 4 Trial Design: Overview of Study
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