EAN: 9784431558989

SPRINGERBRIEFS IN STATISTICS GROUP-SEQUENTIAL...

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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