LEADER 04274nam 22005895 450 001 9910254078203321 005 20200706082832.0 010 $a4-431-55900-0 024 7 $a10.1007/978-4-431-55900-9 035 $a(CKB)3710000000718379 035 $a(EBL)4537358 035 $a(DE-He213)978-4-431-55900-9 035 $a(MiAaPQ)EBC4537358 035 $a(PPN)194377121 035 $a(EXLCZ)993710000000718379 100 $a20160601d2016 u| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aGroup-Sequential Clinical Trials with Multiple Co-Objectives /$fby Toshimitsu Hamasaki, Koko Asakura, Scott R. Evans, Toshimitsu Ochiai 205 $a1st ed. 2016. 210 1$aTokyo :$cSpringer Japan :$cImprint: Springer,$d2016. 215 $a1 online resource (118 p.) 225 1 $aJSS Research Series in Statistics,$x2364-0057 300 $aDescription based upon print version of record. 311 $a4-431-55898-5 320 $aIncludes bibliographical references at the end of each chapters. 327 $a1. 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. 330 $aThis book focuses on group sequential methods for clinical trials with co-primary endpoints based on the decision-making frameworks for: (1) rejecting the null hypothesis (stopping for efficacy), (2) rejecting the alternative hypothesis (stopping for futility), and (3) rejecting the null or alternative hypothesis (stopping for either futility or efficacy), where the trial is designed to evaluate whether the intervention is superior to the control on all endpoints. For assessing futility, there are two fundamental approaches, i.e., the decision to stop for futility based on the conditional probability of rejecting the null hypothesis, and the other based on stopping boundaries using group sequential methods. In this book, the latter approach is discussed. The book also briefly deals with the group sequential methods for clinical trials designed to evaluate whether the intervention is superior to the control on at least one endpoint. In addition, the book describes sample size recalculation and the resulting effect on power and type I error rate. The book also describes group sequential strategies for three-arm clinical trials to demonstrate the non-inferiority of experimental intervention to actively control and to assess the assay sensitivity to placebo control. 410 0$aJSS Research Series in Statistics,$x2364-0057 606 $aStatistics  606 $aStatistical Theory and Methods$3https://scigraph.springernature.com/ontologies/product-market-codes/S11001 606 $aStatistics for Life Sciences, Medicine, Health Sciences$3https://scigraph.springernature.com/ontologies/product-market-codes/S17030 606 $aStatistics for Social Sciences, Humanities, Law$3https://scigraph.springernature.com/ontologies/product-market-codes/S17040 615 0$aStatistics . 615 14$aStatistical Theory and Methods. 615 24$aStatistics for Life Sciences, Medicine, Health Sciences. 615 24$aStatistics for Social Sciences, Humanities, Law. 676 $a615.50724 700 $aHamasaki$b Toshimitsu$4aut$4http://id.loc.gov/vocabulary/relators/aut$0975993 702 $aAsakura$b Koko$4aut$4http://id.loc.gov/vocabulary/relators/aut 702 $aEvans$b Scott R$4aut$4http://id.loc.gov/vocabulary/relators/aut 702 $aOchiai$b Toshimitsu$4aut$4http://id.loc.gov/vocabulary/relators/aut 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910254078203321 996 $aGroup-Sequential Clinical Trials with Multiple Co-Objectives$92222463 997 $aUNINA