메뉴 건너뛰기




Volumn 28, Issue 29, 2009, Pages 3643-3656

Nonparametric non-inferiority analyses in the three-arm design with active control and placebo

Author keywords

Fieller confidence interval; Multicentre study; Rank test; Relative effect

Indexed keywords

PLACEBO; THIOCTIC ACID;

EID: 72849146423     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3727     Document Type: Article
Times cited : (14)

References (23)
  • 1
    • 0344005734 scopus 로고    scopus 로고
    • ICH Topic E10 Available from
    • ICH Topic E10. Choice of control group in clinical trials, 2000. Available from: http://www.emea.europa.eu/pdfs/human/ich/036496en.pdf.
    • (2000) Choice of Control Group in Clinical Trials
  • 2
    • 72849113480 scopus 로고    scopus 로고
    • Points to consider on the clinical requirements on modified release products submitted as a line extension of existing marketing authorisations, Available from
    • Points to consider on the clinical requirements on modified release products submitted as a line extension of existing marketing authorisations, 2003. Available from: http://www.emea.europa.eu/pdfs/human/ewp/187503en.pdf.
    • (2003)
  • 3
    • 72849147638 scopus 로고
    • Note for guidance on clinical requirements for locally applied, locally acting products, containing known constitutions, Available from
    • Note for guidance on clinical requirements for locally applied, locally acting products, containing known constitutions, 1995. Available from: http://www.emea.europa.eu/pdfs/human/ewp/023995en.pdf.
    • (1995)
  • 5
    • 29844441008 scopus 로고    scopus 로고
    • Establishing efficacy of a new experimental treatment in the 'gold standard' design
    • DOI: 10.1002/bimj.200510169
    • Hauschke D, Pigeot I. Establishing efficacy of a new experimental treatment in the 'gold standard' design. Biometrical Journal 2005; 47:782-786. DOI: 10.1002/bimj.200510169.
    • (2005) Biometrical Journal , vol.47 , pp. 782-786
    • Hauschke, D.1    Pigeot, I.2
  • 6
    • 0037473218 scopus 로고    scopus 로고
    • Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo
    • DOI 10.1002/sim.1450
    • Pigeot I, Schäfer J, Röhmel J, Hauschke D. Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo. Statistics in Medicine 2003; 22:883-899. DOI: 10:1002/sim.1450. (Pubitemid 36322092)
    • (2003) Statistics in Medicine , vol.22 , Issue.6 , pp. 883-899
    • Pigeot, I.1    Schafer, J.2    Rohmel, J.3    Hauschke, D.4
  • 7
    • 2642585618 scopus 로고    scopus 로고
    • Hypothesis testing in the 'gold standard' design for proving the efficacy of an experimental treatment relative to placebo and a reference
    • DOI:10.1081/BIP-120037182
    • Koch A, Röhmel J. Hypothesis testing in the 'gold standard' design for proving the efficacy of an experimental treatment relative to placebo and a reference. Journal of Biopharmaceutical Statistics 2004; 14:315-325. DOI:10.1081/BIP-120037182.
    • (2004) Journal of Biopharmaceutical Statistics , vol.14 , pp. 315-325
    • Koch, A.1    Röhmel, J.2
  • 8
    • 60249095140 scopus 로고    scopus 로고
    • The assessment of non-inferiority in a gold standard design with censored, exponentially distributed endpoints
    • DOI: 10.1002/sim.3348
    • Mielke M, Munk A, Schacht A. The assessment of non-inferiority in a gold standard design with censored, exponentially distributed endpoints. Statistics in Medicine 2008; 27:5093-5110. DOI: 10.1002/sim.3348.
    • (2008) Statistics in Medicine , vol.27 , pp. 5093-5110
    • Mielke, M.1    Munk, A.2    Schacht, A.3
  • 9
    • 39449129871 scopus 로고    scopus 로고
    • Assessing non-inferiority of a new treatment in a three-arm trial in the presence of heteroscedasticity
    • DOI 10.1002/sim.3052
    • Hasler M, Vonk R, Hothorn LA. Assessing non-inferiority of a new treatment in a three-arm trial in the presence of heteroscedasticity. Statistics in Medicine 2008; 27:490-503. DOI: 10.1002/sim.3052. (Pubitemid 351266337)
    • (2008) Statistics in Medicine , vol.27 , Issue.4 , pp. 490-503
    • Hasler, M.1    Vonk, R.2    Hothorn, L.A.3
  • 11
    • 0345775335 scopus 로고    scopus 로고
    • Nonparametric methods in factorial designs
    • DOI: 10.1007/s003620000039
    • Brunner E, Puri ML. Nonparametric methods in factorial designs. Statistical Papers 2001; 42:1-52. DOI: 10.1007/s003620000039.
    • (2001) Statistical Papers , vol.42 , pp. 1-52
    • Brunner, E.1    Puri, M.L.2
  • 12
    • 4344641191 scopus 로고    scopus 로고
    • A nonparametric test for proving noninferiority in clinical trials with ordered categorical data
    • DOI: 10.1002/pst.17
    • Munzel U, Hauschke D. A nonparametric test for proving noninferiority in clinical trials with ordered categorical data. Pharmaceutical Statistics 2003; 2:31-37. DOI: 10.1002/pst.17.
    • (2003) Pharmaceutical Statistics , vol.2 , pp. 31-37
    • Munzel, U.1    Hauschke, D.2
  • 13
    • 0030519976 scopus 로고    scopus 로고
    • A new approach to equivalence assessment in standard comparative bioavailability trials by means of the Mann-Whitney statistic
    • Wellek S. A new approach to equivalence assessment in standard comparative bioavailability trials by means of the Mann-Whitney statistic. Biometrical Journal 1996; 38:695-710. DOI: 10.1002/bimj.4710380608. (Pubitemid 126342747)
    • (1996) Biometrical Journal , vol.38 , Issue.6 , pp. 695-710
    • Wellek, S.1
  • 14
    • 33645469139 scopus 로고    scopus 로고
    • Non-parametric assessment of non-inferiority with censored data
    • DOI: 10.1002/sim.2444
    • Freitag G, Lange S, Munk A. Non-parametric assessment of non-inferiority with censored data. Statistics in Medicine 2006; 25:1201-1217. DOI: 10.1002/sim.2444.
    • (2006) Statistics in Medicine , vol.25 , pp. 1201-1217
    • Freitag, G.1    Lange, S.2    Munk, A.3
  • 15
    • 19144363149 scopus 로고    scopus 로고
    • Pairwise non-parametric non-inferiority test in 3 x 3 cross-over trials: Should we adjust for period?
    • DOI 10.1002/sim.2048
    • Duchateau L, Janssen P. Pairwise non-parametric non-inferiority tests in 3 x 3 cross-over trials: should we adjust for period? Statistics in Medicine 2005; 24:1525-1536. DOI: 10.1002/sim.2048. (Pubitemid 40716351)
    • (2005) Statistics in Medicine , vol.24 , Issue.10 , pp. 1525-1536
    • Duchateau, L.1    Janssen, P.2
  • 16
    • 0000063441 scopus 로고
    • A fundamental formula in the statistics of biological assay, and some applications
    • Fieller EC. A fundamental formula in the statistics of biological assay, and some applications. Quarterly Journal of Pharmacy and Pharmacology 1944; 17:117-123.
    • (1944) Quarterly Journal of Pharmacy and Pharmacology , vol.17 , pp. 117-123
    • Fieller, E.C.1
  • 18
    • 0034393195 scopus 로고    scopus 로고
    • The nonparametric Behrens - Fisher problem: Asymptotic theory and a small sample approximation
    • DOI: 10.1002/(SICI)1521-4036(200001)42:1〈17::AIDBIMJ17〉3.0. CO;2-U
    • Brunner E, Munzel U. The nonparametric Behrens - Fisher problem: asymptotic theory and a small sample approximation. Biometrical Journal 2000; 42:17-25. DOI: 10.1002/(SICI)1521-4036(200001)42:1〈17::AIDBIMJ17〉3.0. CO;2-U.
    • (2000) Biometrical Journal , vol.42 , pp. 17-25
    • Brunner, E.1    Munzel, U.2
  • 21
    • 29844456173 scopus 로고    scopus 로고
    • On confidence bounds for the ratio of net differences in the gold standard design with reference, experimental, and placebo treatment
    • DOI 10.1002/bimj.200510178
    • Röhmel J. On confidence bounds for the ratio of net differences in the gold standard design with reference, experimental, and placebo treatment. Biometrical Journal 2005; 47:799-806. DOI: 10.1002/bimj.200510178. (Pubitemid 43037331)
    • (2005) Biometrical Journal , vol.47 , Issue.6 , pp. 799-806
    • Rohmel, J.1
  • 22
    • 0034365567 scopus 로고    scopus 로고
    • Nonparametric tests in the unbalanced multivariate one-way design
    • DOI: 10.1002/1521-4036(200011)42:7〈837::AID-BIMJ837〉3.0.CO;2-S
    • Munzel U, Brunner E. Nonparametric tests in the unbalanced multivariate one-way design. Biometrical Journal 2000; 42:837-854. DOI: 10.1002/1521- 4036(200011)42:7〈837::AID-BIMJ837〉3.0.CO;2-S.
    • (2000) Biometrical Journal , vol.42 , pp. 837-854
    • Munzel, U.1    Brunner, E.2
  • 23
    • 0040968778 scopus 로고    scopus 로고
    • A Unified Approach to Simultaneous Rank Test Procedures in the Unbalanced One-way Layout
    • DOI 10.1002/1521-4036(200109)43:5<553::AID-BIMJ553>3.0.CO;2-N
    • Munzel U, Hothorn L. A unified approach to simultaneous rank test procedures in the unbalanced one-way layout. Biometrical Journal 2001; 43:553-569. DOI: 10.1002/1521-4036(200109)43:5〈553::AID-BIMJ553〉3.0. CO;2-N. (Pubitemid 33333129)
    • (2001) Biometrical Journal , vol.43 , Issue.5 , pp. 553-570
    • Munzel, U.1    Hothorn, L.A.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.