Surrogate Endpoints in Pivotal Clinical Trials for Drug Approval in Japan Compared to the United States.

Clin Transl Sci · 2025 · PMC12605959 · PMID 41221783

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a decreasing trendno p-value reported

There were 65 drugs (6.4%) that used a different SEP than that of the FDA (EP‐nSEP); however, annual trends revealed a decreasing trend of EP‐nSEP use in 2016–2022.

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