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Akademický článek

Progress and challenges of confirmatory trials for cancer drugs granted conditional approval in China

Autor: Xingxian Luo, Yang Xu, Xin Du, Xufeng Lv, Si Chen, Yue Yang, Lin Huang, Xiaohong Zhang

Publikováno v: The Lancet Regional Health. Western Pacific, Vol 52, Iss , Pp 101238- (2024)

Externí odkaz: https://doaj.org/article/4e47de022c884c71b4bc8da87f619c8b

Akademický článek

Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022Research in context

Autor: Xingxian Luo, Xin Du, Lin Huang, Qixiang Guo, Xufeng Lv, Cen Wang, Haopeng Liu, Yue Zhou, Xuecai Xue, Zhuangqi Li, Jingwen Liu, Shein-Chung Chow, Yue Yang

Publikováno v: EClinicalMedicine, Vol 63, Iss , Pp 102177- (2023)

Summary: Background: Accelerated approval (AA) of novel anticancer drugs based on surrogacy has attracted considerable concern globally. China National Medical Products Administration (NMPA) also established a similar conditional approval (CA) progra

Externí odkaz: https://doaj.org/article/7835359a841d46439270663cc2de348a

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Assessment of Clinical Trial Evidence and Surrogate Endpoints Strength for The Cancer Drugs Granted Conditional Approval in China

Autor: Xingxian Luo, Xin Du, Lin Huang, Qixiang Guo, Xufeng Lv, Miao Wang, Haopeng Liu, Yue Zhou, Xuecai Xue, Zhuangqi Li, Jingwen Liu, Shein-Chung Chow, Yue Yang

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::834f366ebd2bce695660cc4374cf0a4e
https://doi.org/10.2139/ssrn.4429945

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