摘要
目的为地市级医院开展药物临床试验工作提供参考。方法介绍我院药物临床试验工作模式和经验,分析地市级医院开展药物临床试验工作存在的主要问题,并对进一步提升地市级医院药物临床试验工作水平提出了思考。结果与结论地市级医院开展药物临床试验工作存在机构配置不全、研究者经验不足,受试者难以接受等问题。地市级医院需严格遵守国家法律法规的要求,健全管理机构,加大软硬件投入,充分利用优势专业和优势资源,借助外部资源,以点带面,才能促进药物临床试验工作的规范开展。
Objective To provide references for municipal hospital to carry out the work of drug clinical trials. Methods The mode and experience of clinical trials in our hospital were introduced, and the main problems to carry out drug clinical trials in municipal hospital were analysed.Suggestions and thinkings were put forward to further enhance the level of drug clinical trials in municipal hospital. Results & Conclusion There were many proplems to carry out the work of drug clinical trials in municipal hospital such as incomplete organization configuration, insufficient experience of researchers, patients difficult acception of subjects. In order to promote the standardization of drug clinical trials, the municipal hospital should strictly abide by the requirements of national laws and regulations, perfect management organization, increase hardware and software investment,make full use of the advantages of professional and dominant resources, utilize external resources, fan out from a point to an area.
作者
易丹
YI Dan(Central Hospital of Zhuzhou, Hunan Zhuzhou 412007, China)
出处
《中国药物警戒》
2016年第10期598-601,共4页
Chinese Journal of Pharmacovigilance
关键词
药物临床试验
实践
思考
drug clinical trial
practice
thinking
