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- W3025620009 abstract "Single arm trial (SAT) was widely used for new drug application (NDA) of novel anti-cancer drugs in recent years. The listing time was greatly shortened by SAT while comparing with randomized controlled trials (RCT). Thus, the companies intended to get NDA through SAT. To encourage innovation and accelerate the developments of anti-cancer agents, we summarize the background and key issues of SAT, discuss the conditions of accepting SAT for NDA, and systematically elaborate the design and principles of SAT in this review.近年来单臂试验被越来越多地用于抗肿瘤新药的注册申请。与随机对照试验比较，单臂试验显著缩短了药品的上市时间，因此企业均期望以单臂数据支持新药注册。为鼓励创新，加速抗肿瘤药物研发，文章从单臂试验的产生背景、核心问题以及单臂试验支持注册的标准等方面，系统阐述了抗肿瘤药物单臂试验的设计和原则。." @default.
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- W3025620009 date "2018-01-23" @default.
- W3025620009 modified "2023-10-18" @default.
- W3025620009 title "[Considerations for anti-cancer drug application by single arm trials]." @default.
- W3025620009 doi "https://doi.org/10.3760/cma.j.issn.0253-3766.2018.01.011" @default.
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