Mark D. Rothmann, Brian L. Wiens, Ivan S. F. Chan

Design and Analysis of Non-Inferiority Trials (eBook, PDF)

• Format: PDF

Produktbeschreibung

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.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 454
• Erscheinungstermin: 19. April 2016
• Englisch
• ISBN-13: 9781584888055
• Artikelnr.: 38327722

Autorenporträt

Dr. Mark Rothmann earned his Ph. D. in Statistics at the University of Iowa. He taught several years as a professor and has worked at the U. S. Food and Drug Administration. He has done research in many areas involving the design and analysis of clinical trials.

Dr. Brian L. Wiens, received his MS in statistics from Colorado State University and his Ph.D. in statistics from Temple University. He has worked at several pharmaceutical, biotechnology and medical device companies since 1991. He has published research in several areas of design and analysis of clinical trials. Dr. Wiens is a Fellow of the American Statistical Association.

Dr. Ivan S.F. Chan received his M.S. in Statistics from The Chinese University of Hong Kong and his Ph.D. in Biostatistics from University of Minnesota. He has worked at Merck Research Laboratories since 1995 and is currently Senior Director and Franchise Head for vaccines, leading the statistical support for all vaccine clinical research programs at Merck. Dr. Chan has published research in many areas of statistics including exact inference, analysis of non-inferiority trials, and methodologies for clinical trials.

Inhaltsangabe

What Is a Non
Inferiority Trial? Non
Inferiority Trial. Considerations. Strength of Evidence and Reproducibility. Evaluating the Active Control Effect. Across
Trials Analysis Methods. Three
Arm Non
Inferiority Trials. Multiple Comparisons. Missing Data and Analysis Sets. Safety Studies. Additional Topics. Inference on Proportions. Inferences on Means and Medians. Inference on Time
to
Event End Points. Appendix: Statistical Concepts. Index.