Step-Down Parametric Procedures for Testing Correlated Endpoints in a Group-Sequential Trial

被引:10
作者
Fu, Yiyong [1 ]
机构
[1] TechData Serv Co LLC, 700 Amer Ave,Suite 102, King Of Prussia, PA 19406 USA
关键词
Closure method; Consonant procedure; Family-wise error rate; Group-sequential; Multiple testing procedure; CLINICAL-TRIALS; MULTIPLE;
D O I
10.1080/19466315.2017.1369898
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Maurer and Bretz developed a class of group-sequential weighted Bonferroni procedures with multiple endpoints. Performed as a step-down consonant shortcut to the group-sequential closed testing procedure, the class of procedures of Maurer and Bretz is simple to use for testing multiple endpoints in classical group-sequential settings. This class uses the correlations of sequential statistics, but does not leverage the correlations between endpoints. Thus, there is room for power improvement by suitably using the between-endpoint correlations in a group-sequential trial while maintaining strong control of the family-wise error rate. To this end, we propose a Holm-type step-down exact parametric procedure for situations in which between-endpoint correlations are known a priori or estimable. An adaptive strategy is suggested for situations in which such correlations are unknown. In addition, we briefly discuss a natural group-sequential extension of the partially parametric Seneta-Chen procedure.
引用
收藏
页码:18 / 25
页数:8
相关论文
共 19 条
[1]   Graphical approaches for multiple comparison procedures using weighted Bonferroni, Simes, or parametric tests [J].
Bretz, Frank ;
Posch, Martin ;
Glimm, Ekkehard ;
Klinglmueller, Florian ;
Maurer, Willi ;
Rohmeyer, Kornelius .
BIOMETRICAL JOURNAL, 2011, 53 (06) :894-913
[2]   STEP-DOWN MULTIPLE TESTS FOR COMPARING TREATMENTS WITH A CONTROL IN UNBALANCED ONE-WAY LAYOUTS [J].
DUNNETT, CW ;
TAMHANE, AC .
STATISTICS IN MEDICINE, 1991, 10 (06) :939-947
[3]  
Hjalmarson Å, 1999, LANCET, V353, P2001
[4]  
HOLM S, 1979, SCAND J STAT, V6, P65
[5]   Statistical considerations for testing multiple endpoints in group sequential or adaptive clinical trials [J].
Hung, H. M. James ;
Wang, Sue-Jane ;
O'Neill, Robert .
JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2007, 17 (06) :1201-1210
[6]   A flexible fixed-sequence testing method for hierarchically ordered correlated multiple endpoints in clinical trials [J].
Huque, Mohammad F. ;
Alosh, Mohamed .
JOURNAL OF STATISTICAL PLANNING AND INFERENCE, 2008, 138 (02) :321-335
[7]   GROUP SEQUENTIAL DESIGNS USING A FAMILY OF TYPE-I ERROR-PROBABILITY SPENDING FUNCTIONS [J].
HWANG, IK ;
SHIH, WJ ;
DECANI, JS .
STATISTICS IN MEDICINE, 1990, 9 (12) :1439-1445
[8]  
Jennison C., 1999, GROUP SEQUENTIAL MET
[9]   DISCRETE SEQUENTIAL BOUNDARIES FOR CLINICAL-TRIALS [J].
LAN, KKG ;
DEMETS, DL .
BIOMETRIKA, 1983, 70 (03) :659-663
[10]  
MARCUS R, 1976, BIOMETRIKA, V63, P655, DOI 10.2307/2335748