基于中心药房的建立提升临床试验管理水平

Improving the management level of clinical trial based on the establishment of drug clinical trial center pharmacy

目的探讨医院药物临床试验机构在建立药物临床试验中心药房过程中的经验与体会。方法通过分析在既往各专业管理药品模式时出现的问题,讨论建立药物临床试验中心药房的必要性和可行性。并对中心药房场地、仪器设备、人员等硬件设施和电子管理系统、标准操作规程等软件设施的规划与建设进行讨论。结果由中心药房统一对试验用药品进行管理后,各科室节省了空间和能源,节省了人力和物力,临床试验质量也得到了提升。结论通过建立药物临床试验中心药房对试验用药品进行统一、规范的管理,是确保受试者用药安全和试验结果科学准确的有力保障。

Objective To discuss our drug clinical trial institution's experience and findings during the process of establishing drug clinical trial central pharmacy.Methods Analyze the previous key issues identified during the drug management under different modes,discuss the necessity and feasibility of establishing drug clinical trial central pharmacy.Meanwhile,discuss the planning and construction of hardware including location site of the central pharmacy,equipment and facilities,staff,as well as software such as electronic management system and standard operation procedures.Results After the adoption of central trial pharmacy,space and energy are saved,manpower and material resources are saved,the quality of clinical trials also improved.Conclusions Standardized and unified management of investigational drugs through establishing drug clinical trial central pharmacy,is the strong guarantee for the drug safety of human subject,as well as the accuracy and scientificity of trial results.