Group-sequential clinical trials with multiple co-objectives /

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Bibliographic Details
Imprint:Japan : Springer, 2016.
Description:1 online resource (ix, 113 pages) : illustrations
Series:SpringerBriefs in statistics, JSS research series in statistics, 2191-544X
SpringerBriefs in statistics. JSS research series in statistics.
Subject:Clinical trials -- Statistical methods.
Clinical Trials as Topic -- statistics & numerical data.
MEDICAL -- Pharmacology.
Clinical trials -- Statistical methods.
Electronic books.
Electronic books.
Format: E-Resource Book
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Other authors / contributors:Hamasaki, Toshimitsu, author.
Asakura, Koko, author.
Evans, Scott R., author.
Ochiai, Toshimitsu, author.
Digital file characteristics:text file PDF
Notes:Includes bibliographical references.
Online resource; title from PDF title page (SpringerLink, viewed June 13, 2016).
Summary: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.
Other form:Print version: Hamasaki, Toshimitsu. Group-Sequential Clinical Trials with Multiple Co-Objectives. Tokyo : Springer Japan, ©2016 9784431558989
Standard no.:10.1007/978-4-431-55900-9