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The challenges of determining noninferiority margins: A case study of noninferiority randomized controlled trials of novel oral anticoagulants
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doi:10.1503/cmaj.120142, Epub ahead of print
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Wangge G, Roes KC, de Boer A, Hoes AW, Knol MJ. The challenges of determining noninferiority margins: a case study of noninferiority randomized controlled trials of novel oral anticoagulants. CMAJ, doi:10.1503/cmaj.120142 (2012) (Epub ahead of print).
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(2012)
CMAJ
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Wangge, G.1
Roes, K.C.2
De Boer, A.3
Hoes, A.W.4
Knol, M.J.5
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49
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84867468040
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Current development in clinical trials: Issues old and new
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doi:10.1002/sim.5405, Epub ahead of print
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Demets DL. Current development in clinical trials: issues old and new. Stat. Med. doi:10.1002/sim.5405 (2012) (Epub ahead of print). • Selection of a noninferiority margin can be impacted by assumptions that can neither be validated nor quantified (as well as by practical considerations). As a starting point the noninferiority margin can be based on the efficacy difference that would affect clinical practice. To avoid misleadingly optimistic claims about the test drug, the comparator must represent the most efficacious standard in use at the initiation of the trial.
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(2012)
Stat. Med.
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Demets, D.L.1
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