volume 22, issue 2, P187-200 2002
DOI: 10.1002/sim.1137
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Abstract: To demonstrate in a clinical trial that a new or experimental therapy (et) is 'at least as good as' a standard therapy (st), a statistical test or confidence interval procedure must rule out clinical inferiority with a high probability. The term 'at least as good as' implies equivalent but not necessarily superior efficacy. As it is statistically impossible to demonstrate equivalence (that is, prove the null hypothesis of no difference), Blackwelder proposed a one-sided significance test to reject the null hyp…

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