title: Group-Sequential Strategies in Clinical Trials with Multiple Co-Primary Outcomes.
abstract: We discuss the decision-making frameworks for clinical trials with multiple co-primary endpoints in a group-sequential setting. The decision-making frameworks can account for flexibilities such as a varying number of analyses, equally or unequally spaced increments of information and fixed or adaptive Type I error allocation among endpoints. The frameworks can provide efficiency, i.e., potentially fewer trial participants, than the fixed sample size designs. We investigate the operating characteristics of the decision-making frameworks and provide guidance on constructing efficient group-sequential strategies in clinical trials with multiple co-primary endpoints.
authors.affiliation: Office of Biostatistics and Data Management, National Cerebral and Cardiovascular Center, Japan ; Department of Innovative Clinical Trials and Data Science, Osaka University Graduate School of Medicine, Japan.
authors.forename: Toshimitsu
authors.initials: T
authors.lastname: Hamasaki
authors.affiliation: Office of Biostatistics and Data Management, National Cerebral and Cardiovascular Center, Japan ; Department of Innovative Clinical Trials and Data Science, Osaka University Graduate School of Medicine, Japan.
authors.forename: Koko
authors.initials: K
authors.lastname: Asakura
authors.affiliation: Department of Biostatistics and the Center for Biostatistics in AIDS Research, Harvard School of Public Health, USA.
authors.forename: Scott R
authors.initials: SR
authors.lastname: Evans
authors.affiliation: Department of Mathematical Sciences, Hirosaki University Graduate School of Science and Technology, Japan.
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Sugimoto
authors.affiliation: Department of Biostatistics, Kyoto University School of Public Health, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Sozu
keywords: Adaptive Type I error allocation; Average sample number; Hierarchical testing procedure; Maximum sample size; equally or unequally spaced increments of information
references.citation: J Biopharm Stat. 2011 Jul;21(4):650-68
references.pmid: 21516562
references.citation: Pharm Stat. 2013 Jan-Feb;12(1):28-34
references.pmid: 23081932
references.citation: Biometrics. 1979 Sep;35(3):549-56
references.pmid: 497341
references.citation: Biometrics. 1999 Sep;55(3):853-7
references.pmid: 11315017
references.citation: Stat Med. 2014 Jul 30;33(17):2897-913
references.pmid: 24676799
references.citation: Stat Med. 2010 Jan 30;29(2):219-28
references.pmid: 19827011
references.citation: Stat Med. 2010 Sep 20;29(21):2169-79
references.pmid: 20687162
references.citation: Stat Med. 2010 Aug 30;29(19):2055-66
references.pmid: 20683896
references.citation: Biostatistics. 2013 Jul;14(3):409-21
references.pmid: 23307913
references.citation: Pharm Stat. 2012 Mar-Apr;11(2):118-28
references.pmid: 22415870
references.citation: Biom J. 2012 Sep;54(5):716-29
references.pmid: 22829198
references.citation: Clin Trials. 2005;2(5):387-93
references.pmid: 16317808
references.citation: J Biopharm Stat. 2007;17(6):1201-10
references.pmid: 18027226
references.citation: Biometrics. 2010 Dec;66(4):1174-84
references.pmid: 20337631
references.citation: J Biopharm Stat. 2004 May;14(2):359-73
references.pmid: 15206533
references.citation: J Biopharm Stat. 2009;19(1):1-11; discussion 12-41
references.pmid: 19127460
references.citation: Stat Med. 2007 Mar 15;26(6):1181-92
references.pmid: 16927251
references.citation: Pharm Stat. 2007 Jul-Sep;6(3):161-70
references.pmid: 17674404
references.citation: Pharm Stat. 2012 Mar-Apr;11(2):177-85
references.pmid: 22383136