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