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A Concise Guide to Clinical Trials


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Table of Contents

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

About the Author

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


"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)

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