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Regulatory Challenges: Is a Surrogate End Point Instead of Overall Survival Enough for Regulatory Approval of (Neo)Adjuvant Cancer Treatment? The Swissmedic Perspective

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JOURNAL OF CLINICAL ONCOLOGY
卷 41, 期 32, 页码 4973-+

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LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1200/JCO.23.01442

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The Swiss regulator emphasizes the insufficiency of relying solely on surrogate endpoints in (neo)adjuvant trials, highlighting the need for a more comprehensive evaluation.
Surrogate end point only is not enough-the Swiss regulator`s perspective on (neo)adjuvant trials.

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