基于国内PD-1/PD-L1抗体药物研发现状探讨临床试验数据公开的重要性  

Discussion about the importance of clinical trial data disclosure in consideration of the current situation of research on PD-1/PD-L1 antibodies in China

作　　者：李欣[1] 李婷[1] 孙菲菲 陶野 蒋鑫 王晨静[1] 曹玉[1] LI Xin;LI Ting;SUN Fei-fei;TAO Ye;JIANG Xin;WANG Chen-jing;CAO Yu(Clinical Trial Center,The Affiliated Hospital of Qingdao University,Qingdao 266003,China)

机构地区：[1]青岛大学附属医院临床试验中心,青岛266003

出　　处：《中国新药杂志》2023年第6期560-566,共7页Chinese Journal of New Drugs

摘　　要：肿瘤新发病例逐年增加,成为药物研发的关注领域。本文通过对国内已上市程序性死亡受体1(PD-1)及程序性死亡配体1(PD-L1)单抗药物临床试验的汇总,结合临床试验注册登记现状,分析数据公开的意义及存在的问题。New cancer cases are increasing year by year,which has become the focus of drug research and development.Based on the summary of clinical trials of programmed cell death-1(PD-1)/programmed death ligand-1(PD-L1)antibody drugs in China,combining with the status of clinical trial registration,this paper analyzes the significance and problems of data disclosure.

关 键 词：临床试验数据公开 程序性死亡受体1 程序性死亡配体1抗体 

分 类 号：R979.1[医药卫生—药品]