Preface vii 1 Basic Design Considerations 1 2 Further Design Considerations 29 3 Binary Outcomes 41 4 Ordered Categorical Outcomes 55 5 Continuous Outcomes 67 6 Rate Outcomes 81 7 Survival Time Outcomes 97 8 Paired Binary, Ordered Categorical and Continuous Outcomes 115 9 Confidence Intervals 135 10 Repeated Outcome Measures 155 11 Non?]Inferiority and Equivalence 167 12 Cluster Designs 193 13 Stepped Wedge Designs 211 14 More than Two Groups Designs 225 15 Genomic Targets and Dose?]Finding 235 16 Feasibility and Pilot Studies 247 17 Therapeutic Exploratory Trials: Single Arm with Binary Outcomes 265 18 Therapeutic Exploratory Trials: Survival, Dual Endpoints, Randomised and Genomic Targets 281 19 The Correlation Coefficient 303 20 Observer Agreement Studies 315 21 Reference Intervals and Receiver Operating Curves 337 22 Sample Size Software 359 Cumulative References 361 Index