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Noninferiority Testing in Clinical Trials - Issues and Challenges (Hardcover)
Loot Price: R2,397
Discovery Miles 23 970
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Noninferiority Testing in Clinical Trials - Issues and Challenges (Hardcover)
Series: Chapman & Hall/CRC Biostatistics Series
Expected to ship within 12 - 17 working days
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Total price: R2,417
Discovery Miles: 24 170
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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.
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