多院区医疗机构临床试验药物管理模式现状调研及探讨

Investigation and Discussion on the Management Mode of Clinical Trial in Multi-campus Hospitals Investigational Products

目的:调研当前各医疗机构多院区发展模式下临床试验药物管理现状,探讨我国多院区医疗机构临床试验药物管理模式发展趋势,并提出建议,以期为医疗机构多院区发展提供一定的参考和借鉴。方法:采用问卷调查方法。选择全国具备开展临床试验资质的医疗机构作为调查对象,围绕医疗机构多院区发展规模、临床试验开展模式、药物管理模式、空间和人员配备、信息化系统使用情况等设计问卷内容,收集数据并统计分析国内临床试验药物的管理现状和发展难点。结果:全国共计29个省(自治区、直辖市)、252家医疗机构参与调研,147家医疗机构具备多院区发展模式。其中,40.14%的医疗机构采用多院区同一项目模式,57.14%的医疗机构采用以主院区设立中心药房,分院区专业组设立卫星药房为主的药物管理模式。多院区中心药房空间布局、人员配备及信息化系统使用程度相对不足。结论:医疗机构多院区临床试验药物管理已成为各医疗机构发展必须应对的难题。建议各医疗机构在主流模式基础上,应根据本院发展特色进行优化和改造,选择适合当前本院临床试验药物的发展模式。

Objective:To investigate the current status of clinical trial investigational product management under the multi-campus hospital development mode of medical institutions,explore the development trend of clinical trial investigational product management mode of multi-campus medical institutions in China,and put forward suggestions for providing reference for the development of multi-campus hospital.Methods:The questionnaire survey method was adopted.Medical institutions qualified to carry out clinical trials were selected as the survey objects,and questionnaire contents were designed based on the development scale of multi-campus hospital,clini‐cal trial development mode,drug management mode,space and staffing,and information system,etc.Data were collected and the status and development difficulties of domestic clinical trial investigational product management were analyzed.Results:A total of 29 provinces(autonomous regions and municipalities directly under the central government)and 252 medical institutions participated in the survey,and 147 medical institutions have multi-campus hospital development mode.Among them,40.14%of medical institutions carried out clinical trials under the same project mode in multi-campus,and 57.14%of medical institutions adopted the drug management mode in which central pharmacies were set up in the main campus and satellite pharmacies were set up in the specialized groups in the branch hos‐pitals.In addition,the space layout,staffing and information system of multi-campus hospital central pharmacy are relatively insuffi‐cient.Conclusion:The clinical trial investigational product management of multi-campus hospitals has become a difficult problem that medical institutions must deal with.It is suggested that medical institutions should optimize and transform according to the development characteristics of the hospital on the basis of the mainstream development mode,and choose the development mode suitable for the cur‐rent clinical trials in the hospital.