메뉴 건너뛰기




Volumn 27, Issue 4, 2007, Pages 284-288

Evaluating "superiority", "equivalence" and "non-inferiority" in clinical trials

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

EID: 34948876462     PISSN: 02564947     EISSN: 13199226     Source Type: Journal    
DOI: 10.5144/0256-4947.2007.284     Document Type: Review
Times cited : (6)

References (13)
  • 1
    • 0041639486 scopus 로고    scopus 로고
    • Active-control clinical trials to establish equivalence or noninferiority: Methodological and statistical concepts linked to quality
    • Gomberg-Maitland M, Frison L, Halperin JL Active-control clinical trials to establish equivalence or noninferiority: Methodological and statistical concepts linked to quality. Am Hearth J. 2003; 146:398-403.
    • (2003) Am Hearth J , vol.146 , pp. 398-403
    • Gomberg-Maitland, M.1    Frison, L.2    Halperin, J.L.3
  • 2
    • 0034687072 scopus 로고    scopus 로고
    • Placebo-controlled trials and active-control trials in the evaluation of new treatments
    • Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Annals of International Medicine. 2000;133(6):455-63.
    • (2000) Annals of International Medicine , vol.133 , Issue.6 , pp. 455-463
    • Temple, R.1    Ellenberg, S.S.2
  • 3
    • 0035159999 scopus 로고    scopus 로고
    • Active-control equivalence trials and antihypertensive agents
    • McAlister FA, Sackett DL. Active-control equivalence trials and antihypertensive agents. Am J. Med. 2001;111:553-8.
    • (2001) Am J. Med , vol.111 , pp. 553-558
    • McAlister, F.A.1    Sackett, D.L.2
  • 4
    • 11144293004 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products CPMP, London, February 26. CPMP/ EWP/2158/99 draft
    • Committee for Proprietary Medicinal Products (CPMP): Points to Consider on the Choice of Non-inferiority Magrin: London, 2004 February 26. CPMP/ EWP/2158/99 draft.
    • (2004) Points to Consider on the Choice of Non-inferiority Magrin
  • 6
    • 0032694404 scopus 로고    scopus 로고
    • Design issues in non-inferiority/equivalence trials
    • Irving KH, Toshihiko M. Design issues in non-inferiority/equivalence trials. Drug Information Journal. 1999; 33:1205-18.
    • (1999) Drug Information Journal , vol.33 , pp. 1205-1218
    • Irving, K.H.1    Toshihiko, M.2
  • 7
    • 1042302883 scopus 로고    scopus 로고
    • Research methods in psychiatry
    • Streiner DL. Research methods in psychiatry, Can J Psychiatry. 2003;48:756-61.
    • (2003) Can J Psychiatry , vol.48 , pp. 756-761
    • Streiner, D.L.1
  • 8
    • 34948849841 scopus 로고    scopus 로고
    • Huson L. Statistical assessment of superiority, equivalence and non-inferiority in clinical trials. OR Focus. 2001;12(5):31-4.
    • Huson L. Statistical assessment of superiority, equivalence and non-inferiority in clinical trials. OR Focus. 2001;12(5):31-4.
  • 9
    • 0036405072 scopus 로고    scopus 로고
    • Relationship between sample size and the definition of equivalence in non-inferiority drug studies
    • Miller JA., Burke V. Relationship between sample size and the definition of equivalence in non-inferiority drug studies. J of Clinical Pharmacy & Therapeutics. 2002;27(5):329-33.
    • (2002) J of Clinical Pharmacy & Therapeutics , vol.27 , Issue.5 , pp. 329-333
    • Miller, J.A.1    Burke, V.2
  • 10
    • 0034687076 scopus 로고    scopus 로고
    • Placebo-controlled trials and active-control trials in the evaluation of new treatments
    • Ellenberg SS, Temple R. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Annals of International Medicine. 2000;133(6):464-70.
    • (2000) Annals of International Medicine , vol.133 , Issue.6 , pp. 464-470
    • Ellenberg, S.S.1    Temple, R.2
  • 11
    • 33644972213 scopus 로고    scopus 로고
    • Planned equivalence or non-inferiority trials versus unplanned noninferiority claims: Are they equal?
    • Chung B, Zee Y. Planned equivalence or non-inferiority trials versus unplanned noninferiority claims: Are they equal? Journal of Clinical Oncology. 2006;24(7):1026-1028.
    • (2006) Journal of Clinical Oncology , vol.24 , Issue.7 , pp. 1026-1028
    • Chung, B.1    Zee, Y.2
  • 12
    • 34948868395 scopus 로고    scopus 로고
    • ICH Topic E9 Statistical Principles for Clinical Trials. Step 4, Consensus Guideline, 5 February 1998. The European Agency for The Evaluation of Medicinal Products Human Medicines Evaluation Unit. London, 1998 March 18. CPMP/ICH/363/96.
    • ICH Topic E9 Statistical Principles for Clinical Trials. Step 4, Consensus Guideline, 5 February 1998. The European Agency for The Evaluation of Medicinal Products Human Medicines Evaluation Unit. London, 1998 March 18. CPMP/ICH/363/96.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.