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Group-sequential clinical trials wit...

Hamasaki, Toshimitsu.

Group-sequential clinical trials with multiple co-objectives

Record Type:	Electronic resources : Monograph/item
Title/Author:	Group-sequential clinical trials with multiple co-objectivesby Toshimitsu Hamasaki ... [et al.].
other author:	Hamasaki, Toshimitsu.
Published:	Tokyo :Springer Japan :2016.
Description:	ix, 113 p. :ill., digital ;24 cm.
Contained By:	Springer eBooks
Subject:	Clinical trialsStatistical methods.
Online resource:	http://dx.doi.org/10.1007/978-4-431-55900-9
ISBN:	9784431559009$q(electronic bk.)

Group-sequential clinical trials with multiple co-objectives
Group-sequential clinical trials with multiple co-objectives[electronic resource] /by Toshimitsu Hamasaki ... [et al.]. - Tokyo :Springer Japan :2016. - ix, 113 p. :ill., digital ;24 cm. - SpringerBriefs in statistics,2191-544X. - SpringerBriefs in statistics..

1. Introduction -- 2. Early Stopping for Efficacy in Clinical Trials with multiple co-primary endpoints -- 3. Sample size recalculation based on observed effects at interim -- 4. Early stopping for futility in Clinical Trials with multiple co-primary endpoints -- 5. Early stopping for futility or Efficacy in Clinical Trials with multiple co-primary endpoints -- 6. Clinical Trials with multiple primary endpoints -- 7. Group-sequential designs for three-arm noninferiority clinical trials -- 8. Further development: topics not covered in this book.

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.

ISBN: 9784431559009$q(electronic bk.)

Standard No.: 10.1007/978-4-431-55900-9doiSubjects--Topical Terms:

181899
Clinical trials
--Statistical methods.

LC Class. No.: R853.C55

Dewey Class. No.: 615.50724

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505 0 $a 1. Introduction -- 2. Early Stopping for Efficacy in Clinical Trials with multiple co-primary endpoints -- 3. Sample size recalculation based on observed effects at interim -- 4. Early stopping for futility in Clinical Trials with multiple co-primary endpoints -- 5. Early stopping for futility or Efficacy in Clinical Trials with multiple co-primary endpoints -- 6. Clinical Trials with multiple primary endpoints -- 7. Group-sequential designs for three-arm noninferiority clinical trials -- 8. Further development: topics not covered in this book.
520 $a 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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