๐”– Scriptorium
โœฆ   LIBER   โœฆ

๐Ÿ“

Group-Sequential Clinical Trials with Multiple Co-Objectives

โœ Scribed by Toshimitsu Hamasaki, Koko Asakura, Scott R. Evans, Toshimitsu Ochiai (auth.)


Publisher
Springer Japan
Year
2016
Tongue
English
Leaves
118
Series
SpringerBriefs in Statistics
Edition
1
Category
Library

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โœฆ Synopsis


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.

โœฆ Table of Contents


Front Matter....Pages i-ix
Introduction....Pages 1-14
Interim Evaluation of Efficacy in Clinical Trials with Two Co-primary Endpoints....Pages 15-39
Sample Size Recalculation in Clinical Trials with Two Co-primary Endpoints....Pages 41-49
Interim Evaluation of Efficacy or Futility in Clinical Trials with Two Co-primary Endpoints....Pages 51-65
Interim Evaluation of Efficacy in Clinical Trials with Two Primary Endpoints....Pages 67-80
Group-Sequential Three-Arm Non-inferiority Clinical Trials....Pages 81-95
Future Developments....Pages 97-102
Back Matter....Pages 103-113

โœฆ Subjects


Statistical Theory and Methods; Statistics for Life Sciences, Medicine, Health Sciences; Statistics for Social Science, Behavorial Science, Education, Public Policy, and Law


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