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Group-Sequential Clinical Trials with Multiple Co-Objectives

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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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Series Title

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Call Number

530 HAM g

Publisher

Tokyo : Springer Tokyo., 2015

Collation

IX, 113

Language

English

ISBN/ISSN

978-4-431-55898-9

Classification

530

Content Type

text

Media Type

computer

Carrier Type

online resource

Edition

-

Subject(s)

Statistical Theory and Methods

Specific Detail Info

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Statement of Responsibility

Toshimitsu Hamasaki , Koko Asakura , Scott R. Evans , Toshimitsu Ochiai

Other Information

Cataloger

Khusnun

Source

-

Validator

maya

Digital Object Identifier (DOI)

-

Journal Volume

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Journal Issue

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Subtitle

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