Adaptive sample size calculations in group sequential trials

被引:407
作者
Lehmacher, W [1 ]
Wassmer, G [1 ]
机构
[1] Univ Cologne, Inst Med Stat Informat & Epidemiol, D-50931 Cologne, Germany
关键词
adaptive interim analysis; clinical trials; group sequential tests; sample size;
D O I
10.1111/j.0006-341X.1999.01286.x
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
A method for group sequential trials that is based on the inverse normal method for combining the results of the separate stages is proposed. Without exaggerating the Type I error rate, this method enables data-driven sample size reassessments during the course of the study. It uses the stopping boundaries of the classical group sequential tests. Furthermore, exact test procedures may be derived for a wide range of applications. The procedure is compared with the classical designs in terms of power and expected sample size.
引用
收藏
页码:1286 / 1290
页数:5
相关论文
共 22 条
[1]   On the power of Fisher's combination test for two stage sampling in the presence of nuisance parameters [J].
Banik, N ;
Kohne, K ;
Bauer, P .
BIOMETRICAL JOURNAL, 1996, 38 (01) :25-37
[2]   EVALUATION OF EXPERIMENTS WITH ADAPTIVE INTERIM ANALYSES [J].
BAUER, P ;
KOHNE, K .
BIOMETRICS, 1994, 50 (04) :1029-1041
[3]  
Bauer P., 1989, BIOMETRIE INFORMATIK, V20, P130
[4]  
DEMETS DL, 1982, BIOMETRIKA, V69, P661
[5]  
DEMETS DL, 1980, BIOMETRIKA, V67, P651
[6]  
Fluhr JW, 1998, ARZNEIMITTEL-FORSCH, V48, P188
[7]  
Gould AL, 1998, STAT MED, V17, P89, DOI 10.1002/(SICI)1097-0258(19980115)17:1<89::AID-SIM730>3.3.CO
[8]  
2-4
[9]  
Hedges LV., 2014, Statistical Methods for Meta -Analysis
[10]  
JENNISON C, 1989, J R STAT SOC B, V51, P305