Textbook of Clinical Trials
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Textbook of Clinical Trials Textbook of Clinical Trials. Edited by D. Machin, S. Day and S. Green 2004 John Wiley & Sons, Ltd ISBN: 0-471-98787-5 Textbook of Clinical Trials Edited by David Machin Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore and UK Children’s Cancer Study Group, University of Leicester, UK. Simon Day Medicines and Healthcare products Regulatory Agency, London, UK Sylvan Green Arizona Cancer Centre, Tucson, Arizona, USA Section Editors Brian Everitt Institute of Psychiatry, London, UK Stephen George Department of Biostatistics and Informatics, Duke University Medical Centre, Durham, NC, USA Copyright 2004 John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex PO19 8SQ, England Telephone (+44) 1243 779777 Email (for orders and customer service enquiries): [email protected] Visit our Home Page on www.wileyeurope.com or www.wiley.com All Rights Reserved. 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If professional advice or other expert assistance is required, the services of a competent professional should be sought. Other Wiley Editorial Offices John Wiley & Sons Inc., 111 River Street, Hoboken, NJ 07030, USA Jossey-Bass, 989 Market Street, San Francisco, CA 94103-1741, USA Wiley-VCH Verlag GmbH, Boschstr. 12, D-69469 Weinheim, Germany John Wiley & Sons Australia 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, Etobicoke, Ontario, Canada M9W 1L1 Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books. Library of Congress Cataloging-in-Publication Data Textbook of clinical trials / edited by David Machin ... [et al.]. p. cm. Includes bibliographical references and index. ISBN 0-471-98787-5 (alk. paper) 1. Clinical trials. I. Machin, David. R853.C55T49 2004 610.724–dc22 2003065147 British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library ISBN 0-471-98787-5 Typeset in 10/12pt Times by Laserwords Private Limited, Chennai, India Printed and bound in Great Britain by Antony Rowe Ltd, Chippenham, Wiltshire 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. Contents Contributors ...................................................... vii Preface .......................................................... xi INTRODUCTION ................................................. 1 1 Brief History of Clinical Trials ..................................... 3 S. Day and F. Ederer 2 General Issues .................................................. 11 David Machin 3 Clinical Trials in Paediatrics ....................................... 45 Johan P.E. Karlberg 4 Clinical Trials Involving Older People ................................ 55 Carol Jagger and Antony J. Arthur 5 Complementary Medicine ......................................... 63 P.C. Leung CANCER 85 6 Breast Cancer .................................................. 87 Donald A. Berry, Terry L. Smith and Aman U. Buzdar 7 Childhood Cancer ............................................... 101 Sharon B. Murphy and Jonathan J. Shuster 8 Gastrointestinal Cancers .......................................... 117 Dan Sargent, Rich Goldberg and Paul Limburg 9 Haematologic Cancers ............................................ 141 Charles A. Schiffer and Stephen L. George vi CONTENTS 10 Melanoma ..................................................... 149 P.-Y. Liu and Vernon K. Sondak 11 Respiratory Cancers ............................................. 159 Kyungmann Kim CARDIOVASCULAR .............................................. 173 12 Cardiovascular ................................................. 175 Lawrence Friedman and Eleanor Schron DENTISTRY AND MAXILLO-FACIAL ............................... 191 13 Dentistry and Maxillo-facial ....................................... 193 May C.M. Wong, Colman McGrath and Edward C.M. Lo DERMATOLOGY ................................................. 209 14 Dermatology ................................................... 211 Luigi Naldi and Cosetta Minelli PSYCHIATRY .................................................... 233 15 Overview ...................................................... 235 B.S. Everitt 16 Alzheimer’s Disease .............................................. 243 Leon J. Thal and Ronald G. Thomas 17 Anxiety Disorders ............................................... 255 M. Katherine Shear and Philip W. Lavori 18 Cognitive Behaviour ............................................. 273 Nicholas Tarrier and Til Wykes 19 Depression ..................................................... 297 Graham Dunn REPRODUCTIVE HEALTH ......................................... 313 20 Contraception .................................................. 315 Gilda Piaggio 21 Gynaecology and Infertility ........................................ 337 Siladitya Bhattacharya and Jill Mollison RESPIRATORY 357 22 Respiratory 359 Anders K¨all´en Index ........................................................... 401 Contributors TONY ARTHUR School of Nursing, Faculty of Medicine and Health Sciences, University of Nottingham, Queens Medical Centre, Nottingham NG7 2UH, UK, Email: [email protected] DONALD BERRY Department of Biostatistics, UTMD Anderson Cancer Centre, 1400 Holcombe Blvd, Box 447, Houston, TX 77030, USA, Email: [email protected] S. BHATTACHARYA Department of Obstetrics and Gynaecology, Aberdeen Maternity Hospital, Cronhill Road, Aberdeen AB25 2ZD, UK, Email: [email protected] ARMAN BUZDAR Department of Breast Medical Oncology, The University of Texas, M.D. Anderson Cancer Centre, Texas, USA SIMON DAY Licensing Division, Medicines and Healthcare products Regulatory Agency, Room 13-205 Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK, Email: [email protected] GRAHAM DUNN Biostatistics Group, School of Epidemiology and Health Sciences, Stopford Building, Oxford Road, Manchester M13 9PT, UK, Email: [email protected], [email protected] FRED EDERER The EMMES Corporation, 401 North Washington Street, Suite 700, Rockville, MD 20850, USA, Email: [email protected] viii CONTRIBUTORS BRIAN EVERITT Box 20, Biostatistics Department, Institute of Psychiatry, Denmark Hill, London SE5 8AF, UK, Email: [email protected] LARRY FRIEDMAN National Heart, Lung, and Blood Institute, Building 31, Room 5A03, Bethesda, MD 20892 2482, USA, Email: [email protected] STEPHEN GEORGE Department of Biostatistics and Bioinformatics, Duke University Medical Centre, Durham, NC 27710, USA, Email: [email protected] RICH GOLDBERG Medical Oncology, Mayo Clinic, 200 1st Street SW, Rochester, MN 55905, USA, Email: [email protected] SYLVAN GREEN Arizona Cancer Centre, 1515 N Campbell Ave, PO Box 245024, Tucson, AZ 85724, USA, Email: [email protected] CAROL JAGGER Trent Institute for HSR, Department of Epidemiology and Public Health, University of Leicester, 22–28 Princess Road West, Leicester LE1 6TP, UK, Email: [email protected] ANDERS KALL¨ EN´ AstraZeneca R&D, Lund, Sweden, Email: [email protected] JOHAN KARLBERG Clinical Trials Centre, Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, PR China, Email: [email protected] KYUNGMANN KIM Department of Biostatistics & Medical Informatics, University of Wisconsin, 600 Highland Avenue, Box 4675, Madison, WI 53792, USA, Email: [email protected] PHILIP LAVORI VACSPCC (151K), 795 Willow Road, Menlo Park, CA 94025 2539, USA, Email: [email protected] P.C. LEUNG Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong, Room 74026, 5th Floor, Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, Email: [email protected] PAUL LIMBURG Gastroenterology and Hepatology, Mayo Clinic, 200 1st Street SW, Rochester, MN 55905, USA, Email: [email protected] CONTRIBUTORS ix P.Y. LIU SWOG Statistical Centre, MP 557, Fred Hutchinson Cancer Research Centre, 1100 Fairview Avenue North, PO Box 19024, Seattle, WA 98109 1024, USA, Email: [email protected] EDWARD LO Dental Public Health, Faculty of Dentistry, The University of Hong Kong, 34 Hospital Road, Hong Kong, Email: [email protected] DAVID MACHIN Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610, Singapore, Email: [email protected], [email protected] COLAMN MCGRATH Dental