Now published in its Second Edition, the Textbook of Clinical
Trials offers detailed coverage of trial methodology in
diverse areas of medicine in a single comprehensive volume.
Praise for the First Edition:
’… very useful as an introduction to clinical research, or
for those planning specific studies within therapeutic or disease
areas.’ BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2,
February 2005
The book’s main concept is to describe the impact of
clinical trials on the practice of medicine. It separates the
information by therapeutic area because the impact of clinical
trials, the problems encountered, and the numbers of trials in
existence vary tremendously from specialty to specialty. The
sections provide a background to the disease area and general
clinical trial methodology before concentrating on particular
problems experienced in that area. Specific examples are used
throughout to address these issues.
The Textbook of Clinical Trials, Second
Edition:
* Highlights the various ways clinical trials have influenced the
practice of medicine in many therapeutic areas
* Describes the challenges posed by those conducting clinical
trials over a range of medical specialities and allied fields
* Additional therapeutic areas are included in this Second
Edition to fill gaps in the First Edition as the number
and complexity of trials increases in this rapidly developing
area
* Newly covered or updated in the Second Edition: general
surgery, plastic surgery, aesthetic surgery, palliative care,
primary care, anaesthesia and pain, transfusion, wound healing,
maternal and perinatal health, early termination, organ
transplants, ophthalmology, epilepsy, infectious disease,
neuro-oncology, adrenal, thyroid and urological cancers, as well as
a chapter on the Cochrane network
An invaluable resource for pharmaceutical companies, the
Textbook of Clinical Trials, Second Edition appeals
to those working in contract research organizations, medical
departments and in the area of public health and health science
alike.
Innehållsförteckning
List of Contributors ix
Preface to Second Edition xvii
Preface the First Edition xix
Introduction 1
1 The Development of Clinical Trials 3
Simon Day
2 General Statistical Issues 13
David Machin
3 The Cochrane Collaboration 39
Mike Clarke
Cancer 47
4 Breast Cancer 49
Donald A. Berry, Terry L. Smith and Aman U. Buzdar
5 Childhood Cancer 63
Sharon B Murphy and Jonathan J.Shuster
6 Gastrointestinal Cancers 81
Daniel Sargent, Richard Goldberg and Paul Limburg
7 Melanoma 105
Ping-Yu Liu and Vernon K. Sondak
8 Respiratory Cancers 121
Joan H. Schiller and Kyungmann Kim
9 Adrenal Cortical Carcinoma 137
Isha Malik and Petros Perros
10 Thyroid Cancer 143
Vijayaraman Arutchelvam and Petros Perros
11 Urologic Cancers 149
Edith D. Canby-Hagino, Catherine M. Tangen, and Ian M. Thompson
12 Haematologic Cancers: Challenges in Developing New Therapeutic Approaches 167
Charles A. Schiffer and Stephen L. George
Cardiology 177
13 Acute Stroke 179
Philip Bath
14 Cardiovascular Disease 215
Krishna Prasad
Dentistry and Oral Health Care 241
15 Dentistry and Oral Health Care 243
May C.M. Wong, Colman Mc Grath and Edward C.M. Lo
Dermatology 261
16 Dermatology 263
Luigi Naldi and Cosetta Minelli
Infectious Diseases 287
17 HIV Infection 289
Michael D. Hughes
18 Infectious Diseases 303
Ingela Krantz
Ophthalmology 317
19 Ophthalmology 319
Jonathan C.K. Clarke and Peng-Tee Khaw
Psychiatry 333
20 Anxiety Disorders 335
M. Katherine Shear and Philip W. Lavori
21 Cognitive Behaviour Therapy 353
Nicholas Tarrier and Til Wykes
22 Psychotherapy for Depression 377
Graham Dunn
Reproductive Health 395
23 Contraception 397
Gilda Piaggio and Timothy M.M. Farley
24 Gynaecology and Infertility 421
Siladitya Bhattacharya and Jill Mollison
25 Early Pregnancy Termination 443
Beverly Winikoff and Batya Elul
26 Maternal and Perinatal Health 459
José Villar, Allan Donner, Edgardo Abalos and Liana Campódonico
Respiratory 475
27 Respiratory Medicine 477
Anders Källén
Surgery & Anaesthesia 517
28 Anaesthesia and Pain 519
Paul S. Myles and John Rigg
29 General Surgery 543
Dr Olga Jonasson and Domenic Reda
30 Plastic Surgery – Reconstructive Surgery 553
Erik Ang and Woffles Wu
31 Plastic Surgery – Aesthetic Surgery 575
Woffles Wu and Erik Ang
Transplantation 591
32 Renal Transplantation 593
Vathsala Anantharaman
Other Procedures 605
33 Wound Healing 607
Colin Song and Edwin Chan
34 Palliative Care 627
Robert S. Krouse and David Casarett
35 Complementary Medicine 647
Ping-Chung Leung
36 Cluster Randomized Trials in Health Care Research 669
Randall D. Cebul, Neal V. Dawson and Thomas E. Love
37 Nursing 681
Nicola Crichton
Special Populations 699
38 Clinical Trials in Paediatrics 701
Johan P.E. Karlberg
39 Clinical Trials Involving Older People 711
Carol Jagger and Antony J. Arthur
40 Clinical Trials in Rare Diseases 723
Simon Day
Index 735
Om författaren
David Machin, Division of Clinical Trials and
Epidemiological Sciences, National Cancer Centre, Singapore.
Simon Day, Medicines and Healthcare Products Regulatory
Agency, London, UK.
Sylvan Green, Arizona Cancer Center, Tucson, Arizona,
USA.
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