메뉴 건너뛰기




Volumn 46, Issue 6, 2012, Pages 647-656

A Statistical Framework for Decision Making in Confirmatory Multipopulation Tailoring Clinical Trials

Author keywords

influence condition; interaction condition; subgroup analysis; tailored therapy; type I error rate

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; PLACEBO;

EID: 84873817347     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/0092861512454116     Document Type: Article
Times cited : (34)

References (22)
  • 2
    • 84873804559 scopus 로고    scopus 로고
    • Herceptin, Accessed July 12, 2012
    • Herceptin. U.S. prescribing information; 1998. http://www.gene.com/gene/products/information/pdf/herceptin-prescribing.pdf. Accessed July 12, 2012.
    • (1998) U.S. prescribing information
  • 3
    • 84873864125 scopus 로고    scopus 로고
    • Xalkori, Accessed July 12, 2012
    • Xalkori. U.S. prescribing information; 2011. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202570s000lbl.pdf. Accessed July 12, 2012.
    • (2011) U.S. prescribing information
  • 4
    • 84873864125 scopus 로고    scopus 로고
    • Zelboraf, Accessed July 12, 2012
    • Zelboraf. U.S. prescribing information; 2011. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429s000lbl.pdf. Accessed July 12, 2012.
    • (2011) U.S. prescribing information
  • 5
    • 84873880959 scopus 로고    scopus 로고
    • Alimta, Accessed July 12, 2012
    • Alimta. U.S. prescribing information; 2004. http://pi.lilly.com/us/alimta-pi.pdf. Accessed July 12, 2012.
    • (2004) U.S. prescribing information
  • 6
    • 70349475409 scopus 로고    scopus 로고
    • SATURN: a double-blind, randomized, phase III study of maintenance erlotinib versus placebo following nonprogression with first-line platinum-based chemotherapy in patients with advanced NSCLC
    • Cappuzzo F,Ciuleanu T,Stelmakh L, et al.SATURN: a double-blind, randomized, phase III study of maintenance erlotinib versus placebo following nonprogression with first-line platinum-based chemotherapy in patients with advanced NSCLC.J Clin Oncol. 2009;27 ((15 S)): 8001.
    • (2009) J Clin Oncol , vol.27 , Issue.15 S , pp. 8001
    • Cappuzzo, F.1    Ciuleanu, T.2    Stelmakh, L.3
  • 7
    • 34648840242 scopus 로고    scopus 로고
    • Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset
    • Wang S,O'Neill R,Hung H.Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset.Pharm Stat. 2007;6:227-244.
    • (2007) Pharm Stat , vol.6 , pp. 227-244
    • Wang, S.1    O'Neill, R.2    Hung, H.3
  • 8
    • 66349125688 scopus 로고    scopus 로고
    • Adaptive patient enrichment designs in therapeutic trials
    • Wang S,Hung H,O'Neill R.Adaptive patient enrichment designs in therapeutic trials.Biom J. 2009;51:358-374.
    • (2009) Biom J , vol.51 , pp. 358-374
    • Wang, S.1    Hung, H.2    O'Neill, R.3
  • 9
    • 34547529442 scopus 로고    scopus 로고
    • A method for testing a prespecified subgroup in clinical trials
    • Song Y,Chi GY.A method for testing a prespecified subgroup in clinical trials.Stat Med. 2007;26:3535-3549.
    • (2007) Stat Med , vol.26 , pp. 3535-3549
    • Song, Y.1    Chi, G.Y.2
  • 10
    • 61749083299 scopus 로고    scopus 로고
    • A flexible strategy for testing subgroups and overall population
    • Alosh M,Huque M.A flexible strategy for testing subgroups and overall population.Stat Med. 2009;28:3-23.
    • (2009) Stat Med , vol.28 , pp. 3-23
    • Alosh, M.1    Huque, M.2
  • 11
    • 79957438038 scopus 로고    scopus 로고
    • On optimal designs of clinical trials with a sensitive subgroup
    • Zhao YD,Dmitrienko A,Tamura R.On optimal designs of clinical trials with a sensitive subgroup.Stat Biopharm Res. 2010;2:72-83.
    • (2010) Stat Biopharm Res , vol.2 , pp. 72-83
    • Zhao, Y.D.1    Dmitrienko, A.2    Tamura, R.3
  • 12
    • 27744537954 scopus 로고    scopus 로고
    • Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients
    • Freidlin B,Simon R.Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients.Clin Cancer Res. 2005;11:7872-7878.
    • (2005) Clin Cancer Res , vol.11 , pp. 7872-7878
    • Freidlin, B.1    Simon, R.2
  • 13
    • 34447264769 scopus 로고    scopus 로고
    • Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect
    • Jiang W,Freidlin B,Simon R.Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect.J Natl Cancer Inst. 2007;99:1036-1043.
    • (2007) J Natl Cancer Inst , vol.99 , pp. 1036-1043
    • Jiang, W.1    Freidlin, B.2    Simon, R.3
  • 15
    • 15944368765 scopus 로고    scopus 로고
    • A fixed-sequence Bonferroni procedure for testing multiple endpoints
    • Wiens B.A fixed-sequence Bonferroni procedure for testing multiple endpoints.Pharm Stat. 2003;2:211-215.
    • (2003) Pharm Stat , vol.2 , pp. 211-215
    • Wiens, B.1
  • 16
    • 27544506961 scopus 로고    scopus 로고
    • The fallback procedure for evaluating a single family of hypotheses
    • Wiens B,Dmitrienko A.The fallback procedure for evaluating a single family of hypotheses.J Biopharm Stat. 2003;15:929-942.
    • (2003) J Biopharm Stat , vol.15 , pp. 929-942
    • Wiens, B.1    Dmitrienko, A.2
  • 17
    • 35348821173 scopus 로고    scopus 로고
    • A flexible fixed-sequence testing method for hierarchically ordered correlated multiple endpoints in clinical trials
    • Huque MF,Alosh M.A flexible fixed-sequence testing method for hierarchically ordered correlated multiple endpoints in clinical trials.J Stat Plann Inference. 2008;138:321-335.
    • (2008) J Stat Plann Inference , vol.138 , pp. 321-335
    • Huque, M.F.1    Alosh, M.2
  • 18
    • 79957529687 scopus 로고    scopus 로고
    • Chain procedures: a class of flexible closed testing procedures with clinical trial applications
    • Millen BA,Dmitrienko A.Chain procedures: a class of flexible closed testing procedures with clinical trial applications.Stat Biopharm Res. 2011;3:14-30.
    • (2011) Stat Biopharm Res , vol.3 , pp. 14-30
    • Millen, B.A.1    Dmitrienko, A.2
  • 19
    • 60749089513 scopus 로고    scopus 로고
    • A graphical approach to sequentially rejective multiple test procedures
    • Bretz F,Maurer W,Brannath W,Posch M.A graphical approach to sequentially rejective multiple test procedures.Stat Med. 2009;28:586-604.
    • (2009) Stat Med , vol.28 , pp. 586-604
    • Bretz, F.1    Maurer, W.2    Brannath, W.3    Posch, M.4
  • 20
    • 64549084568 scopus 로고    scopus 로고
    • A recycling framework for the construction of Bonferroni-based multiple tests
    • Burman CF,Sonesson C,Guilbaud O.A recycling framework for the construction of Bonferroni-based multiple tests.Stat Med. 2009;28:739-761.
    • (2009) Stat Med , vol.28 , pp. 739-761
    • Burman, C.F.1    Sonesson, C.2    Guilbaud, O.3
  • 21
    • 0022072706 scopus 로고
    • Testing for qualitative interactions between treatment effects and patient subsets
    • Gail M,Simon R.Testing for qualitative interactions between treatment effects and patient subsets.Biometrics. 1985;41:361-372.
    • (1985) Biometrics , vol.41 , pp. 361-372
    • Gail, M.1    Simon, R.2
  • 22
    • 0027198279 scopus 로고
    • A comparison of the power of two tests for qualitative interaction
    • Piantadosi S,Gail MH.A comparison of the power of two tests for qualitative interaction.Stat Med. 1993;12:1239-1248.
    • (1993) Stat Med , vol.12 , pp. 1239-1248
    • Piantadosi, S.1    Gail, M.H.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.