某省药物临床试验机构质量管理现状

Current status of quality management of pharmaceutical clinical trial institutions in Anhui province

临床试验是药物研发的一个重要环节,按科学原则进行的临床试验能够直接反映试验药物的安全性与有效性。目前,我国临床试验分为四个阶段(Ⅰ、Ⅱ、Ⅲ、Ⅳ期)。Ⅰ期临床试验大部分在试验机构的一期临床研究室开展,其它阶段则由已通过《药物临床试验质量管理规范》(GCP)认证的医疗机构承担。虽然,我国自GCP实施以来,药物临床试验的总体水平和机构的监管能力都有很大的提升,但是由于我国的药物临床试验起步较晚,各药物临床试验机构的管理水平参差不齐,地区差异性显著。本研究调查了安徽省各个临床试验机构的管理现状,从临床试验项目立项审核、资料管理、管理制度、标准作业程序(Standard Operation Procedure,SOP)、质量控制、药物管理、设备管理、生物样本管理、不良事件(Adverse Event,AE)管理、临床协调员(Clinical research coordinator,CRC)及临床监查员(Clinical Research Associate,CRA)管理、电子系统使用情况等方面,分析目前安徽省药物临床试验机构质量管理现状,为今后安徽省各机构的发展和建设提供一些参考。

Clinical trial is an important part of drug development.Clinical trials conducted according to scientific principles can directly reflect the safety and effectiveness of experimental drugs.At present,China’s clinical trials are divided into four stages(phase I,II,III and IV).Most phase I clinical trials are carried out in the first-phase clinical laboratory of the testing institution,while other stages are carried out by the medical institution that has passed the good clinical practice(GCP)certification.Although the overall level of drug clinical trials and the supervise ability have a lot of ascension since GCP implementation in our country,however,because of drug clinical trials in China starts late,the management level of each drug clinical trial institution is different,and the regional difference is significant.This study investigated the management status quo of the clinical test units in Anhui province,we analyzed the present status of the drug clinical trial institution quality management and the current situation of drug clinical trials of hospitals from the clinical trial project audit,data management,management system,standard operation procedure(SOP),quality control,drug management,equipment management,biological samples,adverse event(AE),clinical research coordinator(CRC)and clinical research associate(CRA)management,use of electronic systems,et al.so as to provide some references for the future development and construction of clinical trial in Anhui.