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
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