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A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials

Allan Hackshaw

ISBN: 978-1-444-35666-3 September 2011 BMJ Books 224 Pages




Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle.

A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations.

This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at:

  • Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials
  • Health professionals who wish to conduct their own trials, or participate in other people’s studies
  • People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies

Preface v

Foreword vii

1 Fundamental concepts 1

2 Types of outcome measures and understanding them 17

3 Design and analysis of phase I trials 31

4 Design and analysis of phase II trials 39

5 Design of phase III trials 57

6 Randomisation 77

7 Analysis and interpretation of phase III trials 91

8 Systematic reviews and meta-analyses 129

9 Health-related quality of life and health economic evaluation 141

10 Setting up conducting and reporting trials 157

11 Regulations and guidelines 187

Reading list 203

Statistical formulae for calculating some 95% confidence intervals 205

Index 209

""This book will be of interest to clinicians who carry out their own trials or become part of multi centre trials. It is an excellent reference guide and provides good background reading material for courses on clinical trials."" (Journal of Tropical Pediatrics, 2011)

""Well illustrated and peppered with illustrative examples for each topic; this is a practical and useful book that achieves its objectives. It is to be recommended."" (ChemMedChem, 2010)