Sample Sizes for Clinical Trials

摘要: Introduction Background to Randomized Controlled Trials Types of Clinical Trial Assessing Evidence from Superiority Equivalence Non-Inferiority As-Good-as-or-Better Assessment Bioequivalence Estimation a Given Precision Seven Key Steps Cook up Sample Size Step 1: Deciding on the Objective 2: Endpoint 3: Determining Effect (or Margin) 4: Population Variability 5: Type I Error 6: II 7: Other Factors Sizes for Parallel Group with Normal Data Estimated Assuming Variance Be Known Design Considerations Revisiting Worked Example Sensitivity Analysis Calculations Taking Account Imprecision Used in Interim Analyses and Re-Estimation Cluster Crossover about Studies Precision-Based Binary Inference Effects Assumed Inclusion Baselines or Covariates Estimates Calculations: Bayesian Methods Revisited Choice Limit Ordinal The Quality-of-Life Survival References Appendix