This book describes group sequential stopping rules designed to reduce average study length and control Type I and Type II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test
Group-Sequential Clinical Trials with Multiple Co-Objectives
โ 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
No coin nor oath required. For personal study only.
โฆ 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.
โฆ 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
โฆ 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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