Cancer Drugs Approved Based on Surrogate Endpoint: A Retrospective Observational Study in the United States and China

Compared to the United States, RR-supported approvals in China are characterized by higher RR values and a stricter RA pathway. Regulatory authorities in both countries may need to consider both the quantity and quality during cancer drug development based on surrogate endpoints.

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Publication Details

Journal
Cancer Medicine
Published
2025-04-01
DOI
https://doi.org/10.1002/cam4.70864
Citations
1
Primary Topic
Statistical Methods in Clinical Trials
Type
article
Field-Weighted Citation Impact
2.63

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article

Cancer Drugs Approved Based on Surrogate Endpoint: A Retrospective Observational Study in the United States and China

Jingru Zhong, Yafang Huang, Ting Zhu
1 citations
Cancer Medicine
Statistical Methods in Clinical Trials
2.63
article

Cancer Drugs Approved Based on Surrogate Endpoint: A Retrospective Observational Study in the United States and China

Jingru Zhong, Yafang Huang, Ting Zhu
article en
1 citations

Abstract

Compared to the United States, RR-supported approvals in China are characterized by higher RR values and a stricter RA pathway. Regulatory authorities in both countries may need to consider both the quantity and quality during cancer drug development based on surrogate endpoints.

Cancer MedicineVol. 14(8)
Capital Medical University (CN)
National Natural Science Foundation of China
Good health and well-being
Openalex Percentile: Top 13%
Statistical Methods in Clinical Trials
2.63
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