Textbook of Clinical Trials Wiley (2004)

409 Pages·2005·2.91 MB·English

Textbook of Clinical Trials
TextbookofClinicalTrials. EditedbyD.Machin,S.DayandS.Green
2004JohnWiley&Sons,Ltd ISBN:0-471-98787-5
Textbook of Clinical Trials
Editedby
David Machin
DivisionofClinicalTrialsandEpidemiologicalSciences,
NationalCancerCentre,SingaporeandUKChildren’sCancerStudyGroup,
UniversityofLeicester,UK.
Simon Day
MedicinesandHealthcareproductsRegulatoryAgency,
London,UK
Sylvan Green
ArizonaCancerCentre,Tucson,Arizona,USA
SectionEditors
Brian Everitt
InstituteofPsychiatry,London,UK
Stephen George
DepartmentofBiostatisticsandInformatics,
DukeUniversityMedicalCentre,Durham,NC,USA
Copyright2004 JohnWiley&SonsLtd,TheAtrium,SouthernGate,Chichester,
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ISBN0-471-98787-5(alk.paper)
1.Clinicaltrials.I.Machin,David.
R853.C55T492004
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2003065147
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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 JaggerandAntony 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, RichGoldberg and PaulLimburg
9 Haematologic Cancers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Charles A. Schiffer andStephen L.George
vi CONTENTS
10 Melanoma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
P.-Y.Liu andVernon K.Sondak
11 Respiratory Cancers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
KyungmannKim
CARDIOVASCULAR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
12 Cardiovascular . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
LawrenceFriedmanand Eleanor Schron
DENTISTRY AND MAXILLO-FACIAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
13 Dentistry and Maxillo-facial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
May C.M.Wong, Colman McGrathand EdwardC.M.Lo
DERMATOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
14 Dermatology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211
Luigi Naldi and CosettaMinelli
PSYCHIATRY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233
15 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
B.S. Everitt
16 Alzheimer’s Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
LeonJ. Thaland Ronald G. Thomas
17 Anxiety Disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255
M. Katherine Shear andPhilip W. Lavori
18 Cognitive Behaviour . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273
Nicholas Tarrier and TilWykes
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 Ka¨lle´n
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 KA¨LLE´N 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 Public Health, Faculty of Dentistry, The University of
Hong Kong, 34 Hospital Road, Hong Kong, Email:
[email protected]
COSETTA MINELLI Medical Statistics Group, Department of Epidemiology and
Public Health, University of Leicester, 22–28 Princess Road
West, Leicester LE1 6TP, UK, Email: [email protected]
JILL MOLLISON Department of Public Health, University of Aberdeen,
Polwarth Building, Foresterhill, Aberdeen AB25 2ZD, UK,
Email: [email protected]
SHARON B. MURPHY Children’s Cancer Research Institute, The University of Texas
Health Science Centre at San Antonio, 7703 Floyd Curl Drive,
MC 7784, San Antonio, TX 78229-3900, USA, Email:
[email protected]
LUIGI NALDI Clinica Dermatologica, Ospedali Riuniti, L.go Barozzi 1,
24100 Bergamo, Italy, Email: [email protected]
GILDA PIAGGIO Special Programme of Research, Development and Research
Training in Human Reproduction, Department of Reproductive
Health and Research, World Health Organisation, 1211
Geneva 27, Switzerland, Email: [email protected]
DANIEL SARGENT Mayo Clinic, 200 First Street, SW, Kahler 1A, Rochester, MN
55905, USA, Email: [email protected]
CHARLES SCHIFFER Division of Oncology and Hematology/Oncology, Karmanos
Cancer Institute, Wayne State University School of Medicine,
Detroit, MI 48201, USA.
ELEANOR SCHRON National Heart, Lung, and Blood Institute, Bethesda, MD
20892 2482, USA, Email: [email protected]
x CONTRIBUTORS
KATHERINE SHEAR Panic Anxiety and Traumatic Grief Program, Western
Psychiatric Institute and Clinic, 3811 O’Hara Street,
Pittsburgh, PA 15213, USA, Email: [email protected],
[email protected]
JON SHUSTER PO Box 100212, College of Medicine, University of Florida,
Gainesville, FL 32610 0212, USA, Email:
[email protected]fl.edu
TERRY SMITH UTMD Anderson Cancer Centre, 1400 Holcombe Blvd, Box
447, Houston, TX 77030, USA, Email:
[email protected]
VERNON K. SONDAK University of Michigan Medical Centre, Division of Surgical
Oncology, 1500 E Medical Centre Drive, 3306
Cancer/Geriatrics Ctr Box 0932, Ann Arbor, MI 48109 0932,
USA, Email: [email protected]
NICHOLAS TARRIER University of Manchester, Academic Division of Clinical
Psychology Education & Research Building, Wythenshawe
Hospital, Southmoor Road, Manchester M23 9LT, UK, Email:
[email protected]
LEON THAL Department of Neurosciences, University of California, San
Diego, 9500 Gilman Drive, San Diego, CA 92037, USA,
Email: [email protected]
RONALD THOMAS Department of Family and Preventative Medicine, and
Neurosciences, UCSD 9500 Gilman Drive, La Jolla, CA
92039 0645, USA, Email: [email protected]
MAY C.M. WONG Dental Public Health, Faculty of Dentistry, The University of
Hong Kong, 34 Hospital Road, Hong Kong, Email:
[email protected]
TIL WYKES Department of Psychiatry, De Crespigny Park, London SE5
8AF, UK, Email: [email protected]