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
Autorentext
Allan Hackshaw
Deputy Director of the Cancer Research UK & UCL Cancer Trials
Centre
Senior Lecturer in Epidemiology & Medical Statistics
Zusammenfassung
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
Inhalt
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