ABSTRACT

The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. Using examples from real clinical trials, Design and Analysis of Non-Inferiority Trials brings together this body of research and confronts the issues involved in the design of a non-inferiority tr

chapter 1|14 pages

- What Is a Non-Inferiority Trial?

chapter 2|28 pages

- Non-Inferiority Trial Considerations

chapter 3|14 pages

- Strength of Evidence and Reproducibility

chapter 4|34 pages

- Evaluating the Active Control Effect

chapter 5|58 pages

- Across-Trials Analysis Methods

chapter 6|18 pages

- Three-Arm Non-Inferiority Trials

chapter 7|14 pages

- Multiple Comparisons

chapter 8|26 pages

- Missing Data and Analysis Sets

chapter 9|12 pages

- Safety Studies

chapter 10|32 pages

- Additional Topics

chapter 11|68 pages

- Inference on Proportions

chapter 12|38 pages

- Inferences on Means and Medians

chapter 13|38 pages

- Inference on Time-to-Event Endpoints