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. 2013 Feb 19;185(3):222-7.
doi: 10.1503/cmaj.120142. Epub 2012 Aug 20.

The challenges of determining noninferiority margins: a case study of noninferiority randomized controlled trials of novel oral anticoagulants

Grace Wangge  1 , Kit C B Roes, Anthonius de Boer, Arno W Hoes, Mirjam J Knol
Affiliations

The challenges of determining noninferiority margins: a case study of noninferiority randomized controlled trials of novel oral anticoagulants

Grace Wangge et al. CMAJ. .
No abstract available

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Figures

Figure 1:
Figure 1:
Results of noninferiority trials, noninferiority margins of the trials, and preserved-effects reference noninferiority margins using risk difference. The confidence intervals resemble the effects of test drug – active comparator (negative treatment effect is desirable). Point-of-no-difference between test drug and enoxaparin is 0.000. CI = confidence interval, M1 = effect of active control versus placebo, M2 = largest clinically acceptable difference between the test drug and the active control, RD = risk difference. *M2 for 67% preserved effect. †M2 for 50% preserved effect. ‡M1.
Figure 2:
Figure 2:
Results of noninferiority trials, noninferiority margins of the trials, and preserved-effects reference noninferiority margins using relative risk. The confidence intervals resemble the effects of test drug –active comparator (negative treatment effect is desirable). Point-of-no-difference between test drug and enoxaparin is 1.000. CI = confidence interval, M1 = effect of active control versus placebo, M2 = largest clinically acceptable difference between the test drug and the active control, RR = relative risk. *M2 for 67% preserved effect. †M2 for 50% preserved effect. ‡M1.
See this image and copyright information in PMC

References

    1. Wangge G, Klungel OH, Roes KC, et al. Interpretation and inference in noninferiority randomized controlled trials in drug research. Clin Pharmacol Ther 2010. ;88:420–3 - PubMed
    1. Wangge G, Klungel OH, Roes KCB, et al. Room for improvement in conducting and reporting non-inferiority randomized controlled trials on drugs: a systematic review. PLoS ONE 2010;5:e13550. - PMC - PubMed
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    1. ICH Expert Working Group ICH Harmonised Tripartite Guideline: Statistical principles for clinical trials. E9 Geneva: ICH; 1998. Available: www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E... (accessed 2012 June 15). - PubMed
    1. ICH Expert Working Group ICH Harmonised Tripartite Guideline: Choice of control group and related issues in clinical trials. E-10 Geneva: ICH; 2000. Available: www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E... (accessed 2012 June 15).

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