A Concise Guide to Clinical Trials

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

Clinical trials have revolutionized the way disease is preventeddetected and treated, and early death avoided, and they continue tobe an expanding area of research. They are central to the work ofpharmaceutical companies, and there are many academic and publicsector organizations that conduct trials on a wide variety ofinterventions, including drugs, devices, surgical techniques, andchanges in behaviour and lifestyle.A Concise Guide to Clinical Trials provides acomprehensive yet easy-to-read overview of the design, conduct andanalysis of trials. It requires no prior knowledge on the subjectas the important concepts are introduced throughout. There arechapters that distinguish between the different types of trialsand an introduction to systematic reviews, health-related qualityof life and health economic evaluation. The book also covers theethical and legal requirements in setting up a clinical trial dueto an increase in governance responsibilities and regulations.This practical guidebook is ideal for busy clinicians and otherhealth professionals who do not have enough time to attend coursesor search through extensive textbooks. It will help anyone involvedin undertaking clinical research, or those reading about trials.The book is aimed at:* Those wishing to learn about clinical trials for the firsttime, or as a quick reference guide, for example as part of ataught course on clinical trials* Health professionals who wish to conduct their own trials, orparticipate in other people's studies* People who work in pharmaceutical companies, grant fundingorganisations, or regulatory agencies

Preface vForeword vii1 Fundamental concepts 12 Types of outcome measures and understanding them 173 Design and analysis of phase I trials 314 Design and analysis of phase II trials 395 Design of phase III trials 576 Randomisation 777 Analysis and interpretation of phase III trials 918 Systematic reviews and meta-analyses 1299 Health-related quality of life and health economic evaluation 14110 Setting up conducting and reporting trials 15711 Regulations and guidelines 187Reading list 203Statistical formulae for calculating some 95% confidence intervals 205Index 209