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Group-Sequential Clinical Trials with Multiple Co-Objectives (Paperback, 1st ed. 2016)
Loot Price: R1,356
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Group-Sequential Clinical Trials with Multiple Co-Objectives (Paperback, 1st ed. 2016)
Series: SpringerBriefs in Statistics
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This book focuses on group sequential methods for clinical trials
with co-primary endpoints based on the decision-making frameworks
for: (1) rejecting the null hypothesis (stopping for efficacy), (2)
rejecting the alternative hypothesis (stopping for futility), and
(3) rejecting the null or alternative hypothesis (stopping for
either futility or efficacy), where the trial is designed to
evaluate whether the intervention is superior to the control on all
endpoints. For assessing futility, there are two fundamental
approaches, i.e., the decision to stop for futility based on the
conditional probability of rejecting the null hypothesis, and the
other based on stopping boundaries using group sequential methods.
In this book, the latter approach is discussed. The book also
briefly deals with the group sequential methods for clinical trials
designed to evaluate whether the intervention is superior to the
control on at least one endpoint. In addition, the book describes
sample size recalculation and the resulting effect on power and
type I error rate. The book also describes group sequential
strategies for three-arm clinical trials to demonstrate the
non-inferiority of experimental intervention to actively control
and to assess the assay sensitivity to placebo control.
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