海南省药物临床试验机构建设现状分析

Analysis of construction status of drug clinical trial institution in Hainan province

目的调研海南省药物临床试验机构建设现状,为主管部门决策提供参考。方法研究对象为海南省所有具备药物临床研究资质的医疗机构,以正式公文形式发送124份问卷至10家医疗机构。问卷内容涉及药物临床试验机构、机构专业组、Ⅰ期临床研究室、机构伦理委员会建设及分析检测实验室情况,发放对象为调研内容相关科室责任人。回收加盖公章的纸质问卷及电子问卷,对数据进行描述性分析。结果124份问卷均有效回收。海南省具备临床研究资质的10家医疗机构近五年共承接药物临床试验495个,总经费超2亿元。机构专业组共备案103个(去重后为26个)专业。Ⅰ期临床研究项目主要集中在海南医学院第一附属医院和海口市人民医院。伦理委员会近5年伦理审查通过率超过90%。尚无专用于生物样本分析检测的实验室。存在问题包括缺乏统一的机构审查和收费标准,人员参与研究积极性低,省内外交流合作少,信息化程度及伦理审查水平不高,整体研究水平有待提升。结论海南省药物临床试验机构建设水平有待提升,可从资金投入、标准统一、人才培养、合作交流、信息化建设、区域伦理委员会等多方面进行完善。

AIM To investigate the current situation of drug clinical trial institution construction in Hainan Province,so as to provide reference for decision-making of competent departments.METHODS The subjects of the study were all medical institutions with drug clinical research qualifications in Hainan Province,and 124 questionnaires were sent to 10 medical institutions in the form of official documents.The contents of the questionnaire involve the drug clinical trial institutions,professional groups of drug clinical trial institutions,phase clinical research center,construction of institutional ethics committees and the situation of analysis and testing laboratories,and was distributed to the responsible persons of relevant departments.The paper questionnaire and electronic questionnaire stamped with official seal were recycled,and the data were analyzed descriptively.RESULTS A total of 124 questionnaires were effectively recovered.In the past five years,10 medical institutions with clinical research qualifications in Hainan Province have undertaken 495 drug clinical trial projects,with a total expenditure of more than 200 million yuan.A total of 103 majors(26 after de duplication)were filed by the professional group.The phase clinical research projects were mainly concentrated in the First Affiliated Hospital of Hainan Medical College and Haikou People’s hospital.The passing rate of ethics review of the ethics committee in recent five years has exceeded 90%.There was no laboratory dedicated to the analysis and detection of biological samples.The existing problems included the lack of unified institutional review and charging standards,the low enthusiasm of personnel to participate in research,the lack of exchanges and cooperation inside and outside the province,the poor level of informatization and ethical review,and the overall research level should be improved.CONCLUSION The construction level of drug clinical trial institutions in Hainan province needs to be improved,which can be improved from capital investment,unified standards,talent training,cooperation and exchange,information construction,regional ethics committees and other aspects.