Noninferiority Testing in Clinical Trials

Tie-Hua Ng

• Introduction. Choice of Noninferiority Margin for the Mean Difference. Choice of Noninferiority Margin for the Mean Ratio and Hazard Ratio. Noninferiority Hypotheses with Binary Endpoints. Two Statistical Approaches for Testing the Noninferiority Hypothesis. Switching between Superiority and Noninferiority. Multiple Historical Studies and Meta-Analysis. Three Treatment Groups. Regulatory Guidances. Intention-to-Treat versus Per-Protocol. Thrombolytic Example. Issues and Challenges. Index.

"The author gives interesting examples and discusses all issues critically with respect to existing literature. Furthermore, striking and convincing motivation is given as well as discussions at the ends of most chapters. Many diagrams and graphs clearly illustrate the respective content and statistical issues. The book allows readers from different fields to understand the concept of NI testing as well as issues and challenges related to NI testing."~Biometrics, 2017"This book is intended for statisticians and non-statisticians working in the area of drug development, and it is written to be easily understood by a broad audience without any prior knowledge of non-inferiority testing. It covers important aspects of non-inferiority testing, including onesided and two-sided hypotheses, equivalence/non-inferiority margins, fixed-margin and the synthesis methods, controversial issues with switching between superiority and non-inferiority testing, tests with binary, continuous and time-to-event endpoints, multiple historical studies and meta-analysis, regulatory guidances, and issues and challenges in these tests."~Lili Zhao, University of Michigan