Textbook of Clinical Trials / Edition 2

by David Machin, Simon Day, Sylvan Green

Overview

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.

Product Details

ISBN-13:	9780470010143
Publisher:	Wiley
Publication date:	01/08/2007
Edition description:	Revised Edition
Pages:	784
Sales rank:	651,344
Product dimensions:	7.73(w) x 9.92(h) x 1.92(d)

About the Author

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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Table of Contents

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 McGrath 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

Editorial Reviews

Reviewer: James C. Torner, PhD, MS (University of Iowa College of Public Health)
Description: This unique compilation of chapters highlights considerations for trials in specific areas using a methodological and state-of-the art approach.
Purpose: The purpose is to demonstrate the advances in clinical trials in methodology and contribution to clinical science. These are worthy objectives, but they limit the audience to those looking for a broad overview. However, this second edition has been expanded to cover more topics, providing a more comprehensive volume.
Audience: The book is best for clinical researchers or practitioners. However, it would be useful for biostatisticians and epidemiologists who need a quick summary of clinical trial design and conduct of trials in a given area. It would be hard to use as a textbook, but it would be a good supplement as a reference for clinicians taking a clinical trial design and conduct course.
Features: Chapters cover clinical trial issues and examples for clinical areas such as cancer, stroke, cardiovascular disease, dermatology, infectious diseases, psychiatry, surgery, etc. Each chapter is somewhat different, but covers major issues of design, measures, outcome assessment, and advances. Some have specific interventions that have been tested. Some have posed issues that need further evaluation. The unique feature of the book is the inclusion of a variety of clinical applications. The shortcoming is the brevity of the chapters covering a given topic. The reference list is essential for readers to expand upon the chapter presentations.
Assessment: This book is different than other clinical trial books in that it focuses on clinical applications rather than design, analysis, and conduct methods with few examples. It also covers a wide spectrum of areas rather than focusing on specific clinical or disease entities. It is needed to give the reader an appreciation that one size or one design doesn't fit all areas of application.

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