ABSTRACT

Take Your NI Trial to the Next LevelReflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI test

chapter 1|22 pages

Introduction

chapter 8|26 pages

Three Treatment Groups

chapter 9|10 pages

Regulatory Guidances

chapter 10|36 pages

Intention-to-Treat versus Per-Protocol

chapter 11|18 pages

Thrombolytic Example

chapter 12|10 pages

Issues and Challenges