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
相关论文
共 50 条
  • [41] Glomerular filtration rate in patients with atrial fibrillation on warfarin treatment: A subgroup analysis from the AURICULA registry in Sweden
    Jonsson, Karl M.
    Wieloch, Mattias
    Sterner, Gunnar
    Nyman, Ulf
    Elmstahl, Solve
    Engstrom, Gunnar
    Svensson, Peter J.
    THROMBOSIS RESEARCH, 2011, 128 (04) : 341 - 345
  • [42] AN ERROR RATE ANALYSIS OF EXPERIMENTAL-DATA TESTING NASH REFINEMENTS
    HARLESS, DW
    CAMERER, CF
    EUROPEAN ECONOMIC REVIEW, 1995, 39 (3-4) : 649 - 660
  • [43] CASSER: A Closed-Form Analysis Framework for Statistical Soft Error Rate
    Chang, Austin C. -C.
    Huang, Ryan H. -M.
    Wen, Charles H. -P.
    IEEE TRANSACTIONS ON VERY LARGE SCALE INTEGRATION (VLSI) SYSTEMS, 2013, 21 (10) : 1837 - 1848
  • [44] STATISTICAL ANALYSIS OF THE WORD ERROR RATE MEASUREMENT IN ANALOG-TO-DIGITAL CONVERTERS
    Catelani, Marcantonio
    Zanobini, Andrea
    Ciani, Lorenzo
    XIX IMEKO WORLD CONGRESS: FUNDAMENTAL AND APPLIED METROLOGY, PROCEEDINGS, 2009, : 694 - 697
  • [46] Asian Subgroup Analysis of a Phase II Study Evaluating Lorlatinib Efficacy in Previously Treated ALK-Positive Advanced NSCLC
    Soo, R.
    Lin, C.
    Kim, D.
    Seto, T.
    Tan, E.
    Hayashi, H.
    Abbattista, A.
    Martini, J.
    Wong, C. H.
    Toffalorio, F.
    Solomon, B.
    JOURNAL OF THORACIC ONCOLOGY, 2021, 16 (03) : S660 - S660
  • [47] Immune subgroup analysis for non-small cell lung cancer may be a good choice for evaluating therapeutic efficacy and prognosis
    Tian, Yuan
    Wang, Jingnan
    Wen, Qing
    Su, Guohai
    Sun, Yuping
    AGING-US, 2021, 13 (09): : 12691 - 12709
  • [48] Evaluating effect of teriflunomide on cortical atrophy in a subgroup analysis of patients defined by baseline MRI activity in the Phase 3 TOPIC study
    Zivadinov, R.
    Dwyer, M. G.
    Carl, E.
    Thangavelu, K.
    Cavalier, S.
    Bergsland, N.
    EUROPEAN JOURNAL OF NEUROLOGY, 2017, 24 : 580 - 580
  • [49] Account for Clinical Heterogeneity in Assessment of Catheter-based Renal Denervation among Resistant Hypertension Patients: Subgroup Meta-analysis
    Chen, Xiao-Han
    Kim, Sehee
    Zeng, Xiao-Xi
    Chen, Zhi-Bing
    Cull, Tian-Lei
    Hu, Zhang-Xue
    Li, Yi
    Fu, Ping
    CHINESE MEDICAL JOURNAL, 2017, 130 (13) : 1586 - +
  • [50] Account for Clinical Heterogeneity in Assessment of Catheter-based Renal Denervation among Resistant Hypertension Patients: Subgroup Meta-analysis
    Chen Xiao-Han
    Kim Sehee
    Zeng Xiao-Xi
    Chen Zhi-Bing
    Cui Tian-Lei
    Hu Zhang-Xue
    Li Yi
    Fu Ping
    中华医学杂志英文版, 2017, 130 (13) : 1586 - 1594