Clinical Trials Design in Operative and Non Operative Invasive Procedures
The aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results. The text provides al
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Kamal M.F. Itani Domenic J. Reda Editors
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Clinical Trials Design in Operative and Non Operative Invasive Procedures
Kamal M.F. Itani Domenic J. Reda •
Editors
Clinical Trials Design in Operative and Non Operative Invasive Procedures
123
Editors Kamal M.F. Itani Department of Surgery, VA Boston Health Care System Boston University and Harvard Medical School West Roxbury, MA USA
ISBN 978-3-319-53876-1 DOI 10.1007/978-3-319-53877-8
Domenic J. Reda Department of Veterans Affairs, Cooperative Studies Program Coordinating Center Hines VA Hospital Hines, IL USA
ISBN 978-3-319-53877-8
(eBook)
Library of Congress Control Number: 2017932081 © Springer International Publishing AG 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 Springer Nature The registered company is Springer International Publishing AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
To Gheed, Fawzi and Karim for their continuous and unwavering support. To VA Boston Health Care system, its patients and staff for being part of my clinical trials. Kamal Itani To the three Mary’s in my life. Domenic Reda
Foreword I
I highly recommend the new text on “Clinical Trials Design in Operative and Non Operative Invasive Procedures” edited by Drs. Itani and Reda. Dr. Itani is a recognized surgical clinical trialist from the Boston VA Medical Center, and Dr. Reda is the Director of the Department of Veterans Affairs Cooperative Studies Program Coordinating Center located in Hines, Illinois. Together they have a wealth of experience in designing, coordinating and conducting clinical trials, which is reflected in the depth and breadth of coverage in this book. The book is an outgrowth of clinical trials courses offered by the American College of Surgeons and the VA Cooperative Studies Program in which
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