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- W4241645660 abstract "Abstract Noninferiority trials employ a selected active‐control treatment, the effect of which has been established in historical placebo‐controlled trials. The active control serves as a comparator for evaluating the effect of an experimental treatment. A placebo arm may be either present in or absent from the noninferiority trial, depending on whether use of the placebo arm is feasible. In contrast with showing superiority, it is much more challenging to design a “show noninferiority” trial. The notion of noninferiority is extremely difficult to define, and a threshold termed “noninferiority margin” must be determined to define the noninferiority hypothesis for testing. The margin determination depends on many key factors: the objective of the noninferiority trial, critical assumptions pertaining to the ability of a trial to distinguish between an effective and an ineffective treatments, and the applicability of the historical estimate of the active control's effect to the noninferiority trial when the placebo cannot be used, and so forth. This article is intended to pinpoint the factors critically needing consideration for the viability of using a noninferiority trial to evaluate the effect of an experimental treatment." @default.
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- W4241645660 date "2007-12-14" @default.
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- W4241645660 title "Non-Inferiority Trial" @default.
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