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Volumn 35, Issue 9, 2012, Pages 522-523

Increasing proportion of clinical trials using noninferiority end points

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; TENECTEPLASE;

EID: 84866234985     PISSN: 01609289     EISSN: 19328737     Source Type: Journal    
DOI: 10.1002/clc.22040     Document Type: Note
Times cited : (11)

References (8)
  • 1
    • 0034930111 scopus 로고    scopus 로고
    • The general concepts of an equivalence trial, applied to ASSENT-2, a large-scale mortality study comparing two fibrinolytic agents in acute myocardial infarction
    • Lesaffre E, Bluhmki E, Wang-Clow F, et al. The general concepts of an equivalence trial, applied to ASSENT-2, a large-scale mortality study comparing two fibrinolytic agents in acute myocardial infarction. Eur Heart J. 2001; 22: 898-902.
    • (2001) Eur Heart J. , vol.22 , pp. 898-902
    • Lesaffre, E.1    Bluhmki, E.2    Wang-Clow, F.3
  • 2
    • 0033612881 scopus 로고    scopus 로고
    • Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: The ASSENT-2 double-blind randomised trial
    • Van De Werf F, Adgey J, Ardissino D, et al. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial. Lancet. 1999; 354: 716-722.
    • (1999) Lancet. , vol.354 , pp. 716-722
    • Van De Werf, F.1    Adgey, J.2    Ardissino, D.3
  • 3
    • 84877095385 scopus 로고    scopus 로고
    • International Conference on Harmonisation-Efficacy US Department of Health and Human Services, US Food and Drug Administration Accessed October 3, 2011
    • International Conference on Harmonisation-Efficacy. Guidance for industry: E9 statistical principles for clinical trials. US Department of Health and Human Services, US Food and Drug Administration; 1998. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073137.pdf. Accessed October 3, 2011.
    • (1998) Guidance for Industry: E9 Statistical Principles for Clinical Trials
  • 4
    • 33644789375 scopus 로고    scopus 로고
    • Quality of reporting of noninferiority and equivalence randomized trials
    • Le Henanff A, Giraudeau B, Baron G, et al. Quality of reporting of noninferiority and equivalence randomized trials. JAMA. 2006; 295: 1147-1151.
    • (2006) JAMA , vol.295 , pp. 1147-1151
    • Le Henanff, A.1    Giraudeau, B.2    Baron, G.3
  • 5
    • 33644792767 scopus 로고    scopus 로고
    • The CONSORT Group. Reporting of noninferiority and equivalence randomized trials
    • Piaggio G, Elbourne DR, Altman DG, et al. the CONSORT Group. Reporting of noninferiority and equivalence randomized trials. JAMA. 2006; 295: 1152-1160.
    • (2006) JAMA. , vol.295 , pp. 1152-1160
    • Piaggio, G.1    Elbourne, D.R.2    Altman, D.G.3
  • 7
    • 38949173080 scopus 로고    scopus 로고
    • Current issues in non-inferiority trials
    • Fleming TR., Current issues in non-inferiority trials. Stat Med. 2008; 27: 317-332.
    • (2008) Stat Med , vol.27 , pp. 317-332
    • Fleming, T.R.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.