A Statistical Concept for Conditional Marketing Authorisation Based on the Intermediate and Final Outcomes of a Single Confirmatory Randomised Clinical Trial.

Pharm Stat · 2026 · PMC12911536 · PMID 41701010

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a positive trendno p-value reported

If only the intermediate endpoint is significant at the interim analysis, and there is no detriment in the final endpoint (or a positive trend can be shown), a CMA may be justified and the trial will proceed to the final analysis.

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