Noninferiority Testing in Clinical Trials - Issues and Challenges (Paperback)

Take Your NI Trial to the Next Level Reflecting 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 testing, the book is easily accessible to both statisticians and nonstatisticians involved in drug development. With over 20 years of experience in this area, the author introduces the basic elements of the NI trials one at a time in a logical order. He discusses issues with estimating the effect size based on historical placebo control trials of the active control. The book covers fundamental concepts related to NI trials, such as assay sensitivity, constancy assumption, discounting, and preservation. It also describes patient populations, three-arm trials, and the equivalence of three or more groups.

General

Imprint:	Crc Press
Country of origin:	United Kingdom
Series:	Chapman & Hall/CRC Biostatistics Series
Release date:	June 2020
First published:	2015
Authors:	Tie-Hua Ng
Dimensions:	234 x 156mm (L x W)
Format:	Paperback
Pages:	208
ISBN-13:	978-0-367-57602-8
Categories:	Books > Science & Mathematics > Mathematics > Probability & statistics Books > Science & Mathematics > Biology, life sciences > General Books > Medicine > General issues > Medical equipment & techniques > Medical research Books > Medicine > General issues > Public health & preventive medicine > Epidemiology & medical statistics Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology Promotions
LSN:	0-367-57602-3
Barcode:	9780367576028

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