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Considerations for anti-cancer drug application by single arm trials / 中华肿瘤杂志
Chinese Journal of Oncology ; (12): 58-62, 2018.
Article in Chinese | WPRIM | ID: wpr-809804
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.

Full text: Available Index: WPRIM (Western Pacific) Type of study: Controlled clinical trial Language: Chinese Journal: Chinese Journal of Oncology Year: 2018 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Type of study: Controlled clinical trial Language: Chinese Journal: Chinese Journal of Oncology Year: 2018 Type: Article