Application of Real-World Evidence in the Approval of Antitumor Drugs  

作　　者：Shang Ya’nan Huang Zhe 

机构地区：[1]School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China

出　　处：《Asian Journal of Social Pharmacy》2024年第4期311-318,共8页亚洲社会药学（英文）

摘　　要：Objective To study the information of real-world evidence(RWE)that can make up the deficiency of RCT results,the unfeasibility of some trials and the possible ethical problems,and to promote the approval of RWE for anti-tumor drugs.Methods Literature analysis,policy analysis and comparative analysis were used.Results and Conclusion The studies and application of RWE in the United States,the European Union,and China were reviewed.The approval of anti-tumor drugs supported by RWE was generally used for external control groups in single arm trials,clinical efficacy and safety of adjuvant support drugs,or background analysis.The types of approvals included innovative anti-tumor drugs,supplemented indications of the approved drugs,expanding patient population,and combination medication.This study can provide reference for the approval of anti-tumor drugs using RWE in China.It is recommended to combine traditional RCT with RWE to promote the approval of anti-tumor drugs.

关 键 词：real-world evidence antitumor drugs APPROVAL 

分 类 号：R943[医药卫生—药剂学]