Dictionary For Clinical Trials

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This is a unique and comprehensive book providing clearly written definitions of the clinical trial terms likely to be found in trial protocols, reports, regulatory guidelines and published manuscripts. Definitions, often used in regulatory guidelines have been simplified and are free from jargon. * Defines over 2700 words and short phrases commonly used in clinical trials * Scope includes medical, statistical, epidemiological, ethical, regulatory and data management terminology * Extensively cross-referenced * Illustrated with line figures and graphs Wide ranging and succinct, the Dictionary of Clinial Trials is the essential pocket reference guide for all those working in clinical trials, including clinicians, statisticians and those within the pharmaceutical industry as well as ethics committees and grant-awarding organisations. It has been written by a highly-respected statistician well known in both the academic and pharmaceutical industry fields.

E-Book Content

Dictionary for Clinical Trials Dictionary for Clinical Trials Author: Simon Day Copyright © 1999 John Wiley & Sons Ltd ISBNs: 0-471-98611-9 (Hardback); 0-471-98596-1 (Paperback); 0-470-84256-3 (Electronic) To Nikki, Anya and Huw Dictionary for Clinical Trials Simon Day Medical Department, Leo Pharmaceuticals, Princes Risborough, UK JOHN WILEY & SONS, LTD Chichester · New York · Weinheim · Brisbane · Singapore · Toronto Copyright © 1999 by John Wiley & Sons Ltd, Baffins Lane, Chichester, West Sussex PO19 1UD, England National 01243 779777 International (; 44) 1243 779777 e-mail (for orders and customer service enquiries): [email protected] Visit our Home Page on http://www.wiley.co.uk or http://www.wiley.com 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, scanning or otherwise, except under the terms of the Copyright, Designs and Patents Act 1988 or under the terms of a licence issued by the Copyright Licensing Agency, 90 Tottenham Court Road, London, UK W1P 9HE, without the permission in writing of John Wiley & Sons Ltd, Baffins Lane, Chichester, West Sussex, UK PO19 1UD. Other Wiley Editorial Offices John Wiley & Sons, Inc., 605 Third Avenue, New York, NY 10158-0012, USA WILEY-VCH Verlag GmbH, Pappelallee 3, D-69469 Weinheim, Germany Jacaranda Wiley Ltd, 33 Park Road, Milton, Queensland 4064, Australia John Wiley & Sons (Asia) Pte Ltd, 2 Clementi Loop 02-01, Jin Xing Distripark, Singapore 129809 John Wiley & Sons (Canada) Ltd, 22 Worcester Road, Rexdale, Ontario M9W 1L1, Canada Library of Congress Cataloging-in-Publication Data Day, Simon. Dictionary for clinical trials / Simon Day. p. cm. Includes bibliographical references. ISBN 0-471-98611-9 (cased : alk. paper).—ISBN 0-471-98596-1 (paper : alk. paper) 1. Clinical trials—Dictionaries. I. Title. [DNLM: 1. Clinical Trials dictionaries. QV 13 D275d 1999] R853.C55D39 1999 610 .7 2—dc21 DNLM/DLC for Library of Congress 99—11151 CIP British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library ISBN 0-471-98611-9 (cased) ISBN 0-471-98596-1 (paper) Typeset in 9/10 pt Times from the author’s disks by Vision Typesetting, Manchester in Great Britain by Antony Rowe Ltd., Chippenham, Wiltshire Printed and bound This book is printed on acid-free paper responsibly manufactured from sustainable forestry, in which at least two trees are planted for each one used for paper production iv Preface It is now fifty years since the British Medical Research Council published the results of a trial entitled ‘Streptomycin treatment of pulmonary tuberculosis’ (Br