文章摘要
福建省药物临床试验机构备案现状分析
Analysis of the Current Registering Situation of Drug Clinical Trial Institutions in Fujian Province
投稿时间：2023-12-26  修订日期：2024-04-08
DOI：
中文关键词: 福建省 药物临床试验机构 备案制 临床试验
英文关键词: Fujian Province, Drug Clinical trial institutions, Registration system, Clinical trial
基金项目:2021年福州市卫生健康中青年科学研究项目“临床研究协调员管理模式探索”(编号2021-S-wq44）
作者单位邮编
林小倩 福建医科大学孟超肝胆医院 350000
黄芳玲 福建医科大学孟超肝胆医院 
郑玲* 福建医科大学孟超肝胆医院 350000
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中文摘要:
      目的：探究我国2019年12月施行药物临床试验机构备案制后，福建省药物临床试验机构的备案现状。方法：以国家药物临床试验机构备案管理信息系统平台和药物临床试验登记与信息公示平台公开的数据为基础，从备案机构数量及地域分布、备案机构级别、备案专业、备案主要研究者以及药物临床试验开展情况等方面对福建省药物临床试验机构备案现状进行系统分析。结果与结论：福建省药物临床试验备案机构总数量较少，反映出福建省医疗机构对药物临床试验重视程度不足，且机构地域分布和临床试验开展数量存在分布不均衡的现象。目前我省仍有大量医疗机构具备备案资质，建议监管部门加大对药物临床试验机构建设的支持力度，鼓励更多有条件的医疗机构参与机构备案，开展药物临床试验，同时已备案机构需加强对临床试验质量的重视，促进临床试验健康发展。
英文摘要:
      Objective: To investigate the Current Registering Situation of Drug Clinical Trial Institutions in Fujian Province after the registration system from December 2019. Method: Based on the publicly available data of Clinical Trial Institution on the official website of National Medical Products Administration and the Drug Clinical Trial Registration Platform, statistical analysis was made on the current situation of drug clinical trial institution registration in Fujian Province from the aspects of the quality and geographical distribution, level of registration institutions, registration specialties, primary investigator involved in registration, and the quality of drug clinical trials. Results and Conclusion: The total number of registered drug clinical trial institutions in Fujian Province is relatively low, reflecting the insufficient attention of medical institutions to drug clinical trials in Fujian Province, the uneven distribution of institutional geographical distribution, and the number of clinical trials conducted. Currently, there are still many qualified medical institutions for registering drug clinical trial institutions in Fuzhou province. It is suggested that regulatory authorities should pay more attention to drug clinical trial institution's development. More qualified medical institutions should register for Drug Clinical Trial Institutions and conduct drug clinical trials. Registered institutions must strengthen their attention to the quality of clinical trials to achieve promising development of clinical trials.
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