Group-Sequential Clinical Trials with Multiple Co-Objectives - Couverture souple

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

 
9784431558989: Group-Sequential Clinical Trials with Multiple Co-Objectives

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.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

À propos de l?auteur

Toshimitsu Hamasaki, Professor, National Cerebral and Cardiovascular Center, 5-7-1 Fujishirodai, Suita, Osaka 565-8565, Japan
Koko Asakura, Research Assistant, National Cerebral and Cardiovascular Center, 5-7-1 Fujishirodai, Suita, Osaka 565-8565, Japan
Scott Richard Evans, Senior Research Scientist, Harvard School of Public Health, 651 Huntington Avenue, Boston, Massachusetts 02115, USAToshimitsu Ochiai, Biostatistics Department, Shionogi & Co., Ltd., Japan

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Autres éditions populaires du même titre

9784431558996: Group-Sequential Clinical Trials with Multiple Co-Objectives

Edition présentée

ISBN 10 :  4431558993 ISBN 13 :  9784431558996
Editeur : Springer, 2016
Couverture souple