STATISTICAL PERSPECTIVES ON SUBGROUP ANALYSIS: TESTING FOR HETEROGENEITY AND EVALUATING ERROR RATE FOR THE COMPLEMENTARY SUBGROUP

被引:11
|
作者
Alosh, Mohamed [1 ]
Huque, Mohammad F. [2 ]
Koch, Gary G. [3 ]
机构
[1] US FDA, Div Biometr 3, Off Biostat, OTS,CDER, Silver Spring, MD 20993 USA
[2] US FDA, OTS, Off Biostat, CDER, Silver Spring, MD 20993 USA
[3] Univ N Carolina, Dept Biostat, Chapel Hill, NC USA
关键词
Complementary subgroup error rate; Supportive assessment; Targeted subgroup; Testing for interaction; QUALITATIVE INTERACTIONS; CLINICAL-TRIALS; POWER;
D O I
10.1080/10543406.2014.971169
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Substantial heterogeneity in treatment effects across subgroups can cause significant findings in the overall population to be driven predominantly by those of a certain subgroup, thus raising concern on whether the treatment should be prescribed for the least benefitted subgroup. Because of its low power, a nonsignificant interaction test can lead to incorrectly prescribing treatment for the overall population. This article investigates the power of the interaction test and its implications. Also, it investigates the probability of prescribing the treatment to a nonbenefitted subgroup on the basis of a nonsignificant interaction test and other recently proposed criteria.
引用
收藏
页码:1161 / 1178
页数:18
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