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Volumn 88, Issue 3, 2010, Pages 420-423

Interpretation and inference in noninferiority randomized controlled trials in drug research

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG; PLACEBO;

EID: 77955920451     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2010.134     Document Type: Review
Times cited : (24)

References (17)
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    • Hung, H.M.1    Wang, S.J.2    O'Neill, R.3
  • 2
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    • Non-inferiority trials: Design concepts and issues-the encounters of academic consultants in statistics
    • D'Agostino, R.B. sr, Massaro, J.M. & Sullivan, L.M. Non-inferiority trials: design concepts and issues-the encounters of academic consultants in statistics. Stat. Med. 22, 169-186 (2003).
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    • D'Agostino Sr., R.B.1    Massaro, J.M.2    Sullivan, L.M.3
  • 3
    • 36549021534 scopus 로고    scopus 로고
    • Non-inferiority trials are unethical because they disregard patients' interests
    • Garattini, S. & Bertele', V. Non-inferiority trials are unethical because they disregard patients' interests. Lancet 370, 1875-1877 (2007)
    • (2007) Lancet , vol.370 , pp. 1875-1877
    • Garattini, S.1    Bertele, V.2
  • 5
    • 2642576574 scopus 로고    scopus 로고
    • Alternatives for discounting in the analysis of noninferiority trials
    • Snapinn, S.M. Alternatives for discounting in the analysis of noninferiority trials. J. Biopharm. Stat. 14, 263-273 (2004).
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    • Snapinn, S.M.1
  • 6
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    • Challenges and regulatory experiences with non-inferiority trial design without placebo arm
    • Hung, H.M.J., Sue-Jane, W., Robert, O.N. Challenges and regulatory experiences with non-inferiority trial design without placebo arm. Biom. J. 51, 324-334 (2009).
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    • Hung, H.M.J.1    Sue-Jane, W.2    Robert, O.N.3
  • 7
    • 77955917671 scopus 로고    scopus 로고
    • Guideline on the choice of the non-inferiority margin
    • CHMp EMEA/CpMp/EWp/2158/99 (EMEA
    • CHMp. Guideline on the choice of the non-inferiority margin. In EMEa, Vol EMEA/CpMp/EWp/2158/99 (EMEA, 2005).
    • (2005) EMEa
  • 8
    • 0242383409 scopus 로고    scopus 로고
    • Efcacy and safety of oral weekly ibandronate in the treatment of postmenopausal osteoporosis
    • Cooper, C. et al. Efcacy and safety of oral weekly ibandronate in the treatment of postmenopausal osteoporosis. J. Clin. Endocrinol. Metab. 88, 4609-4615 (2003).
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    • Cooper, C.1
  • 9
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    • Stastistical principles for clinical trials\E9
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  • 11
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.