药师在药物临床试验中的角色与定位

Role of pharmacists in drug clinical trials

药物临床试验的新政策赋予了医院药师更多的挑战与机遇,药师应该发挥自己的专业优势,促进我国药物临床试验的高质量发展。本文结合本院实际情况,探讨医院药师在药物临床试验中的角色与定位。医院药师在药物临床试验项目启动前参与立项及伦理审查,在临床试验进行中参与药品管理、质量控制以及信息化改造,在试验结束后参与药品清点回收以及文件保管等各项工作。这些工作提高了药物临床试验的质量,保障了受试者的用药安全。

New national policies for clinical trials present hospital pharmacists more challenges and opportunities.Pharmacists should give full play to their professional advantages to promote the highquality development of drug clinical trials in China.This article explored the role of hospital pharmacists in clinical trials based on the practice in our hospital.Clinical pharmacists parcitipated the censorship of the establishment and ethics of clinical trial projects before initiation,drug management and project quality control during the trials,and checking and recovery of drugs or document management after the trials.These work improved the quality of drug clinical trials and ensured the medication safety of subjects in the clinical trials.