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Abstract:
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In a trial of superiority over an active drug, do we need to re-establish assay sensitivity or effectiveness of the active comparator? Can we assume it? Can we use historical information collected in the recent past? If not, do we need to establish it by including placebo arm in the trial? Can we test equivalence or noninferiority when superiority cannot be established? How does one resolve the issues regarding adequate sample size, appropriate analysis population, and clinically meaningful difference delta for declaring equivalence or noninferiority? Gray areas in decisionmaking while testing equivalence or noninferiority lead to the issue of an ambiguity in the present practice of testing superiority.
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