Considerations for anti?cancer drug application by single arm trials

VernacularTitle:单臂试验支持抗肿瘤新药注册的考虑
Author: Ming ZHOU ¹ ; Xiaoyuan CHEN ; Hong ZHANG ; Lin XIA ; Xin TONG ; Liming ZOU ; Ruimin HAO ; Xiao ZHAO ; Yuankai SHI ; Zhimin YANG
Author Information

1. 国家食品药品监督管理总局药品审评中心
Keywords: Single arm trial; Neoplasms; New drug application
From: Chinese Journal of Oncology 2018;40(1):58-62
CountryChina
Language:Chinese
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.