04274nam 22005895 450 991025407820332120200706082832.04-431-55900-010.1007/978-4-431-55900-9(CKB)3710000000718379(EBL)4537358(DE-He213)978-4-431-55900-9(MiAaPQ)EBC4537358(PPN)194377121(EXLCZ)99371000000071837920160601d2016 u| 0engur|n|---|||||txtrdacontentcrdamediacrrdacarrierGroup-Sequential Clinical Trials with Multiple Co-Objectives /by Toshimitsu Hamasaki, Koko Asakura, Scott R. Evans, Toshimitsu Ochiai1st ed. 2016.Tokyo :Springer Japan :Imprint: Springer,2016.1 online resource (118 p.)JSS Research Series in Statistics,2364-0057Description based upon print version of record.4-431-55898-5 Includes bibliographical references at the end of each chapters.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.JSS Research Series in Statistics,2364-0057Statistics Statistical Theory and Methodshttps://scigraph.springernature.com/ontologies/product-market-codes/S11001Statistics for Life Sciences, Medicine, Health Scienceshttps://scigraph.springernature.com/ontologies/product-market-codes/S17030Statistics for Social Sciences, Humanities, Lawhttps://scigraph.springernature.com/ontologies/product-market-codes/S17040Statistics .Statistical Theory and Methods.Statistics for Life Sciences, Medicine, Health Sciences.Statistics for Social Sciences, Humanities, Law.615.50724Hamasaki Toshimitsuauthttp://id.loc.gov/vocabulary/relators/aut975993Asakura Kokoauthttp://id.loc.gov/vocabulary/relators/autEvans Scott Rauthttp://id.loc.gov/vocabulary/relators/autOchiai Toshimitsuauthttp://id.loc.gov/vocabulary/relators/autMiAaPQMiAaPQMiAaPQBOOK9910254078203321Group-Sequential Clinical Trials with Multiple Co-Objectives2222463UNINA