药物临床试验项目实施过程中常见问题与应对策略  

Common problems and countermeasures in the implementation of drug clinical trial project

作　　者：赵同香[1] 马丽萍[1] 王海英[1] 向平超[1] ZHAO Tongxiang MA Liping WANG Haiying XIANG Pingchao(Drug Clinical Trial Institutes Office, Peking University Shougang Hospital, Beijing 100144, China)

机构地区：[1]北京大学首钢医院药物临床试验机构办公室,北京100144

出　　处：《中国现代医生》2017年第8期146-148,共3页China Modern Doctor

摘　　要：目的回顾和总结药物临床试验过程中的常见问题,为我院后期临床试验项目管理积累经验。方法对我院已结题的27项药物临床试验项目进行项目核查,发现临床试验中常见问题后,对问题进行分类,并针对各类问题提出相应对策。结果我院药物临床试验常见问题主要集中在伦理审查、知情同意、方案实施、数据记录、药物管理和生物样本管理等方面。结论加强药物临床试验过程管理是提高药物临床试验质量的关键。Objective To review and summarize the common problems in the course of drug clinical trial, and to accumulate experience for the late clinical trial project management in our hospital. Methods Project verification was carried out on 27 drug clinical trials which had been finished in our hospital. After the common problems in clinical trials were found, the problems were classified and the corresponding countermeasures for various problems were put forward. Results The common problems of drug clinieal trials in our hospital were mainly focused on ethical review, informed consent, program implementation, data record, drug management and biological sample management. Conclusion Strengthening the management of drug clinical trial process is the key to improve the quality of drug clinieal trials.

关 键 词：药物临床试验 项目核查 过程管理 试验质量 

分 类 号：R95[医药卫生—药学]