David Machin - Randomised Clinical Trials

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Randomi
sed Clinical Trials: Design, Practice and Reporting
This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book: 
Provides comprehensive coverage of randomised clinical trials, ranging from basic to advanced Features several new chapters, updated case studies and examples, and references to changes in regulations Explains basic randomised trials, including the parallel two-group controlled trial with a single outcome measure Covers paired trial designs and trials with more than two interventions Includes a chapter on miscellaneous topics such as adaptive designs, large simple trials, Bayesian methods for very small trials, alpha-spending functions and the predictive probability test  is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.

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Randomised Clinical Trials

Design, Practice and Reporting

Second Edition

David Machin

Leicester Cancer Research Centre

University of Leicester, Leicester, UK

Medical Statistics Group, School of Health and Related Research

University of Sheffield, Sheffield, UK

Peter M. Fayers

Institute of Applied Health

University of Aberdeen, Scotland, UK

Bee Choo Tai

Saw Swee Hock School of Public Health

National University of Singapore and National University Health System Singapore

Singapore, Singapore

This edition first published 2021 2021 John Wiley Sons Ltd Edition - фото 2

This edition first published 2021, © 2021 John Wiley & Sons Ltd

Edition History John Wiley & Sons, Ltd (1e, 2010)

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by law. Advice on how to obtain permission to reuse material from this title is available at http://www.wiley.com/go/permissions.

The right of David Machin, Peter M. Fayers, and Bee Choo Tai to be identified as the authors of this work has been asserted in accordance with law.

Registered Office(s) John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, USA John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK

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Limit of Liability/Disclaimer of Warranty The contents of this work are intended to further general scientific research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting scientific method, diagnosis, or treatment by physicians for any particular patient. In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. While the publisher and authors have used their best efforts in preparing this work, they make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials or promotional statements for this work. The fact that an organization, website, or product is referred to in this work as a citation and/or potential source of further information does not mean that the publisher and authors endorse the information or services the organization, website, or product may provide or recommendations it may make. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.

Library of Congress Cataloging‐in‐Publication Data

Names: Machin, David, 1939- author. | Fayers, Peter M., author. | Tai, Bee Choo, author.

Title: Randomized clinical trials : design, practice and reporting / David Machin, Peter M. Fayers, Bee Choo Tai.

Description: Second edition. | Hoboken, NJ : Wiley-Blackwell, 2021. | Includes bibliographical references and index.

Identifiers: LCCN 2020044539 (print) | LCCN 2020044540 (ebook) | ISBN 9781119524649 (paperback) | ISBN 9781119524656 (adobe pdf) | ISBN 9781119524670 (epub)

Subjects: MESH: Randomized Controlled Trials as Topic–methods | Biomedical Research–methods | Research Design | Data Interpretation, Statistical

Classification: LCC R853.C55 (print) | LCC R853.C55 (ebook) | NLM W 20.55.C5 | DDC 610.72/4–dc23

LC record available at https://lccn.loc.gov/2020044539LC ebook record available at https://lccn.loc.gov/2020044540

Cover Design: Wiley

Cover Image: © Kenishirotie/Shutterstock

To

Lorna Christine Machin

Tessa and Emma Fayers

Isaac Xu‐En and Kheng‐Chuan Koh

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