Design and Analysis of Non-Inferiority Trials

ISBN: 9781584888048 出版年：2016 页码：451 Rothmann, Mark D Wiens, Brian L Chan, Ivan S F CRC Press

What Is a Non-Inferiority Trial? Definition of Non-Inferiority Reasons for Non-Inferiority Trials Different Types of Comparisons A History of Non-Inferiority Trials References Non-Inferiority Trial Considerations Introduction External Validity and Assay Sensitivity Critical Steps and Issues Sizing a Study Example of Anti-Infectives References Strength of Evidence and Reproducibility Introduction Strength of Evidence Reproducibility References Evaluating the Active Control Effect Introduction Active Control Effect Meta-Analysis Methods Bayesian Meta-Analyses References Across-Trials Analysis Methods Introduction Two Confidence Interval Approaches Synthesis Methods Comparing Analysis Methods and Type I Error Rates A Case in Oncology References Three-Arm Non-Inferiority Trials Introduction Comparisons to Concurrent Controls Bayesian Analyses References Multiple Comparisons Introduction Comparing Multiple Groups to an Active Control Non-Inferiority on Multiple End Points Testing for Both Superiority and Non-Inferiority References Missing Data and Analysis Sets Introduction Missing Data Analysis Sets References Safety Studies Introduction Considerations for Safety Study Cardiovascular Risk in Antidiabetic Therapy References Additional Topics Introduction Interaction Tests Surrogate End Points Adaptive Designs Equivalence Comparisons References Inference on Proportions Introduction Fixed Thresholds on Differences Fixed Thresholds on Ratios Fixed Thresholds on Odds Ratios Bayesian Methods Stratified and Adjusted Analyses Variable Margins Matched-Pair Designs References Inferences on Means and Medians Introduction Fixed Thresholds on Differences of Means Fixed Thresholds on Ratios of Means Analyses Involving Medians Ordinal Data References Inference on Time-to-Event End Points Introduction Censoring Exponential Distributions Nonparametric Inference Based on a Hazard Ratio Analyses Based on Landmarks and Medians Comparisons Over Preset Intervals References Appendix: Statistical Concepts Frequentist Methods Bayesian Methods Comparison of Methods Stratified and Adjusted Analyses References Index