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 ¹ ; Hong ZHANG ¹ ; Lin XIA ¹ ; Xin TONG ¹ ; Liming ZOU ¹ ; Ruimin HAO ¹ ; Xiao ZHAO ¹ ; Yuankai SHI ² ; Zhimin YANG ¹
Author Information

1. China Food and Drug Administration Center for Drug Evaluation, Beijing 100038, China
2. Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Publication Type:Journal Article
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.