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Key Points Question How often are surrogate end points used to support the approval of anticancer drugs, and are confirmatory studies that use overall survival as an end point conducted… Click to show full abstract
Key Points Question How often are surrogate end points used to support the approval of anticancer drugs, and are confirmatory studies that use overall survival as an end point conducted in Japan? Findings In this cross-sectional study of 299 anticancer drugs, the number of drugs for which overall survival was used to support approval increased from 1 in 2001 to 2005 to 86 in 2006 to 2020; however, 212 approvals were based on surrogate end points. Postmarketing confirmatory studies using overall survival as an end point were not conducted for 175 approvals. Meaning These findings suggest that the Japanese regulatory agencies need to evaluate approval through surrogate end points and ensure the implementation of postmarketing commitment studies.
Journal Title: JAMA Network Open
Year Published: 2023
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