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Volumn 30, Issue 26, 2011, Pages 3162-3164

Statistical strategies for the analysis of clinical trials with an experimental treatment, an active control and placebo, and a prespecified fixed non-inferiority margin for the difference in means

Author keywords

[No Author keywords available]

Indexed keywords

INTERMETHOD COMPARISON; LETTER; NULL HYPOTHESIS; POWER ANALYSIS; SAMPLE SIZE; SENSITIVITY ANALYSIS; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE;

EID: 80055086038     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.4299     Document Type: Letter
Times cited : (9)

References (13)
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    • Hida E, Tango T. On the three-arm non-inferiority trial including a placebo with a prespecified margin. Statistics in Medicine. 2011; 30:224-231.
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  • 2
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    • Establishing efficacy of a new experimental treatment in the gold standard design
    • Hauschke D, Pigeot I. Establishing efficacy of a new experimental treatment in the gold standard design. Biometrical Journal. 2005; 47:782-786.
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    • Hauschke, D.1    Pigeot, I.2
  • 3
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    • Discussion on "Establishing efficacy of a new experimental treatment in the gold standard design"
    • Lewis JA. Discussion on "Establishing efficacy of a new experimental treatment in the gold standard design". Biometrical Journal. 2005; 47:787-789.
    • (2005) Biometrical Journal , vol.47 , pp. 787-789
    • Lewis, J.A.1
  • 4
    • 29844441641 scopus 로고    scopus 로고
    • Discussion on "Establishing efficacy of a new experimental treatment in the gold standard design"
    • Röhmel J. Discussion on "Establishing efficacy of a new experimental treatment in the gold standard design". Biometrical Journal. 2005; 47:790-791.
    • (2005) Biometrical Journal , vol.47 , pp. 790-791
    • Röhmel, J.1
  • 5
    • 29844440463 scopus 로고    scopus 로고
    • Discussion on "Establishing efficacy of a new experimental treatment in the gold standard design"
    • Koch A. Discussion on "Establishing efficacy of a new experimental treatment in the gold standard design". Biometrical Journal. 2005; 47:792-793.
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    • 29844435529 scopus 로고    scopus 로고
    • Discussion on "Establishing efficacy of a new experimental treatment in the gold standard design"
    • Mehrotra DV. Discussion on "Establishing efficacy of a new experimental treatment in the gold standard design". Biometrical Journal. 2005; 47:794.
    • (2005) Biometrical Journal , vol.47 , pp. 794
    • Mehrotra, D.V.1
  • 7
    • 29844441007 scopus 로고    scopus 로고
    • Discussion on "Establishing efficacy of a new experimental treatment in the gold standard design"
    • Hung HMJ. Discussion on "Establishing efficacy of a new experimental treatment in the gold standard design". Biometrical Journal. 2005; 47:795-796.
    • (2005) Biometrical Journal , vol.47 , pp. 795-796
    • Hung, H.M.J.1
  • 8
    • 29844451225 scopus 로고    scopus 로고
    • Rejoinder to "Establishing efficacy of a new experimental treatment in the gold standard design"
    • Hauschke D, Pigeot I. Rejoinder to "Establishing efficacy of a new experimental treatment in the gold standard design". Biometrical Journal. 2005; 47:797-798.
    • (2005) Biometrical Journal , vol.47 , pp. 797-798
    • Hauschke, D.1    Pigeot, I.2
  • 9
    • 77956295377 scopus 로고    scopus 로고
    • A group sequential type design for three-arm non-inferiority trials with binary endpoints
    • Li G, Gao S. A group sequential type design for three-arm non-inferiority trials with binary endpoints. Biometrical Journal. 2010; 52:504-518.
    • (2010) Biometrical Journal , vol.52 , pp. 504-518
    • Li, G.1    Gao, S.2
  • 10
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    • A Comparison of multiple testing procedures for the gold standard noninferiority trial
    • Röhmel J, Pigeot I. A Comparison of multiple testing procedures for the gold standard noninferiority trial. Journal of Biopharmaceutical Statistics. 2010; 20:911-926.
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    • Röhmel, J.1    Pigeot, I.2
  • 11
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    • 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.
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  • 12
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    • ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials. Available from: [06 January 2011].
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    • ICH Harmonised Tripartite Guideline. Choice of control group and related issues in clinical trials. Available from: [06 January 2011].
    • ICH Harmonised Tripartite Guideline. Choice of control group and related issues in clinical trials. Available from: [06 January 2011].


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.