Group-Sequential Clinical Trials with Multiple Co-Objectives

Toshimitsu Hamasaki, Koko Asakura, Scott R. Evans, Toshimitsu Ochiai (Autoren)

Buch | Softcover

113 Seiten

2016 | 1st ed. 2016
Springer Verlag, Japan
978-4-431-55898-9 (ISBN)

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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.

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

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 is a highly stimulating read for anyone who is interested in group-sequential trials, or anybody who wishes to learn about how studies with multiple endpoints can be made more efficient.” (Michael J. Grayling, Technometrics, Vol. 60 (3), 2018)

Erscheinungsdatum	24.05.2016
Reihe/Serie	JSS Research Series in Statistics
Reihe/Serie	SpringerBriefs in Statistics
Zusatzinfo	14 Illustrations, black and white; IX, 113 p. 14 illus.
Verlagsort	Tokyo
Sprache	englisch
Maße	155 x 235 mm
Themenwelt	Mathematik / Informatik ► Mathematik ► Angewandte Mathematik
	Mathematik / Informatik ► Mathematik ► Wahrscheinlichkeit / Kombinatorik
	Studium ► Querschnittsbereiche ► Epidemiologie / Med. Biometrie
	Sozialwissenschaften ► Soziologie ► Empirische Sozialforschung
Schlagworte	Group Sequential Designs • interim analysis • Multiple endpoints • Noninferiority • Sample Size Calculation • Sample Size Recalculation
ISBN-10	4-431-55898-5 / 4431558985
ISBN-13	978-4-431-55898-9 / 9784431558989
Zustand	Neuware