Ⅰ期临床药物试验室高效二级质量控制系统的构建与思考  

Establishment and Thinking of Effective Level-2 Quality Control System in Phase I Clinical Trial Unit

作　　者：余恒毅 任秀华[1,2] 杜艾桦 刘东[1,2] 王开富[2] 陈倩[1,2] YU Hengyi;REN Xiuhua;DU Aihua;LIU Dong;WANG Kaifu;CHEN Qian(Department of Pharmacy,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Phase I Clinical Trial Unit,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Department of Scientific Research Management,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China)

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,武汉430030 [2]华中科技大学同济医学院附属同济医院Ⅰ期临床试验研究室,武汉430030 [3]华中科技大学同济医学院附属同济医院科研处,武汉430030

出　　处：《医药导报》2020年第9期1312-1314,共3页Herald of Medicine

基　　金：“重大新药创制”科技重大专项(2017ZX09304022)。

摘　　要：为确保Ⅰ期临床药物试验室开展药物临床试验的质量,根据国家《药物临床试验质量管理规范》和《药物临床试验数据现场核查要点》要求,针对药物Ⅰ期临床试验与生物等效性试验的关键环节,构建了Ⅰ期临床药物试验室二级质量控制系统。该质量控制系统对质量控制人员、质量控制形式、质量控制阶段和质量控制内容进行了明确规定,覆盖试验准备、受试者筛选、入组后试验和试验结束等药物试验全过程,保障了我院Ⅰ期临床试验研究室二级质量控制工作的客观性、及时性、专业性和有效性,获得了研究者和申办方的高度认可,在提高药物试验质量、保障受试者权益及安全方面发挥了重要作用。In order to ensure the quality of clinical trials,a sound and effective level-2 quality control(QC) system was established in our phase Ⅰ clinical trial unit,according to the GCP requirements and the key points for on-site verification of drug clinical trial data issued by National Medical Products Administration of China.The QC personnel,QC type,QC stage,and QC content in the level-2 QC system were introduced in this paper,which covered the whole process of clinical trials,including preparation stage,subject screening stage,trail stage and end stage.With the implement of this system,key steps during the process of phase Ⅰ clinical trial and bioequivalence(BE) test were under control objectively,timely,professionally,and effectively,which significantly improved the quality of clinical trials and protected the rights of subjects.

关 键 词：Ⅰ期临床药物试验 生物等效性试验 二级质量控制 

分 类 号：R951[医药卫生—药学]