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. 2012 Sep;35(9):522-3.
doi: 10.1002/clc.22040. Epub 2012 Jul 16.

Increasing proportion of clinical trials using noninferiority end points

Affiliations

Increasing proportion of clinical trials using noninferiority end points

Venkatesh L Murthy et al. Clin Cardiol. 2012 Sep.

Abstract

This study was funded in part by grants from the National Institutes of Health (T32 HL094301‐01A1 and T32 HL007604‐27).

Dr. Bhatt discloses the following relationships ‐ Advisory Board: Medscape Cardiology; Board of Directors: Boston VA Research Institute, Society of Chest Pain Centers; Chair: American Heart Association Get With The Guidelines Science Subcommittee; Honoraria: American College of Cardiology (Editor, Clinical Trials, Cardiosource), Duke Clinical Research Institute (clinical trial steering committees), Slack Publications (Chief Medical Editor, Cardiology Today Intervention), WebMD (CME steering committees); Research Grants: Amarin, AstraZeneca, Bristol‐Myers Squibb, Eisai, Ethicon, Medtronic, Sanofi Aventis, The Medicines Company; Unfunded Research: FlowCo, PLx Pharma, Takeda. Drs. Murthy and Desai have received consulting fees from Novo Nordisk.

The authors have no other funding, financial relationships, or conflicts of interest to disclose.

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Figures

Figure 1
Figure 1
Number of noninferiority studies reported in PubMed by year. Entries were identified by searching for the terms “non‐inferior,” “non‐inferiority,” “noninferior,” or “noninferiority.” Entries were filtered to include only those classified as clinical trials or randomized controlled trials. Data were fit with a linear model using year as the continuous predictor variable.

References

    1. 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. - PubMed
    1. 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. - PubMed
    1. 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/GuidanceComplianceRegulatoryInformati... Accessed October 3, 2011.
    1. Le Henanff A, Giraudeau B, Baron G, et al. Quality of reporting of noninferiority and equivalence randomized trials. JAMA. 2006;295:1147–1151. - PubMed
    1. Piaggio G, Elbourne DR, Altman DG, et al; the CONSORT Group. Reporting of noninferiority and equivalence randomized trials. JAMA. 2006;295:1152–1160. - PubMed

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