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Abstract:
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Non-inferiority trials designed to demonstrate the efficacy of an investigational drug and non-inferiority trials designed to rule out excess harm have fundamental differences. For example, non-inferiority studies for efficacy always have an active control, and have a margin that is based on the magnitude of efficacy of the control agent observed in historical trials, while non-inferiority trials for safety often have a placebo control, and have a margin that is based primarily on clinical considerations. In addition, non-inferiority trials for efficacy involve an indirect comparison to placebo, which leads to concerns regarding the constancy assumption, while non-inferiority trials for safety have no such assumption. In this roundtable we will discuss and contrast the important issues with both types of trials.
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