药物临床试验质量控制的若干思考及实践

Thinking and practice about quality control of clinical drug trials

目的:探讨当前药物临床试验质量管理中存在的问题及应对策略。方法:分析在药物临床试验质量保证中存在的问题,并结合实际情况提出解决办法。结果:上海中医药大学附属曙光医院结合实际情况采取各种举措,使临床试验质量得到提高。结论:药物临床试验质量的提高需要申办者、研究者及药物临床试验机构各方共同努力。

Objective： To explore the problems that existed in clinical drug trials and their countermeasures. Methods： The problems that existed in the quality control of clinical drug trials were analyzed and solutions to those problems were put forth according to practical conditions. Results： In accordance with the practical conditions,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine took various measures to improve the quality of clinical drug trials. Conclusion： The improvement of the quality of clinical drug trials demands combined efforts by sponsors, researchers and drug clinical trial institutions.