A Concise Guide to Clinical Trials

DESCRIPTION

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

TABLE OF CONTENTS

Preface.
1 Fundamental concepts.
2 Types of outcome measures and understanding them.
3 Design and analysis of phase I trials.
4 Design and analysis of phase II trials.
5 Design of phase III trials.
6 Randomisation.
7 Analysis and interpretation of phase III trials.
8 Systematic reviews and meta-analyses.
9 Health-related Quality of Life and Health Economic Evaluation.
10 Setting up, conducting and reporting trials.
11 Regulations and guidelines.
Reading list

AUTHOR INFORMATION

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