" /> Confirmatory Trial - CISMeF





Preferred Label : Confirmatory Trial;

NCIt definition : A type of phase 3 clinical trial in which the previously characterized actions of a therapeutic intervention, in an earlier phase trial, are verified.;

Alternative definition : CDISC-GLOSS: Phase 3 trial with results that confirm the preliminary evidence accumulated in earlier phases that a drug is safe and effective for use for the intended indication and recipient population. [After ICH E8] See also non-confirmatory trial result, pragmatic trial. Compare to exploratory trial.;

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11/05/2025


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