"A Chapman & Hall book."

Includes bibliographical references and index.

1. What is a non-inferiority trial? -- 2. Non-inferiority trial considerations -- 3. Strength of evidence and reproducibility -- 4. Evaluating the active control effect -- 5. Across-trials analysis methods -- 6. Three-arm non-inferiority trials -- 7. Multiple comparisons -- 8. Missing data and analysis sets -- 9. Safety studies -- 10. Additional topics -- 11. Inference on proportions -- 12. Inferences on means and medians -- 13. Inference on time-to-event endpoints.

"The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. 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 trial. Using examples from real clinical trials, the book discusses general and regulatory issues and illustrates how they affect analysis. Each chapter begins with a non-technical introduction, so the subject is easily understood by those without prior knowledge of non-inferiority clinical trials. The book also provides detailed mathematical approaches along with their mathematical properties"--Provided by publisher.

Also available in print edition.

Mode of access: World Wide Web.