文章摘要
林小倩,黄芳玲,郑铃.福建省药物临床试验机构备案现状分析[J].中国药事,2024,38(5):558-566
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 Institutionsin Fujian Province
投稿时间:2023-12-26  
DOI:10.16153/j.1002-7777.2024.05.008
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 institution  registering 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
林小倩 福建医科大学孟超肝胆医院福州 350028 
黄芳玲 福建医科大学孟超肝胆医院福州 350028 
郑铃 福建医科大学孟超肝胆医院福州 350028 
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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。目前福建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 explore the current registering situation of drug clinical trial institutions in FujianProvince after the implementation of the registering system of drug clinical trial institutions in December 2019.Methods: Based on the data of the national drug clinical trial institution registering management informationsystem platform and the drug clinical trial registration and information publicity platform, the current situation ofdrug clinical trial institutions in Fujian Province was systematically analyzed from the aspects of the number andgeographical distribution of registering institutions, the level of registering institutions, the major of registeringinstitutions, the main investigators of registering institutions and the status of drug clinical trials. Results andConclusion: The total number of drug clinical trial registering institutions in Fujian Province was relativelylow, which reflected the insufficient attention of medical institutions to drug clinical trials in Fujian Province,the uneven geographics distribution of institutions and the uneven number of clinical trials. Currently, there arestill many medical institutions with the registering qualifi cation in Fujian Province. It is suggested that regulatoryauthorities should increase the support for the construction of drug clinical trial institutions, and encourage morequalified medical institutions to participate in the registering of institutions, to carry out drug clinical trials, while the registering institutions must pay more attention to the quality of clinical trials to promote the healthydevelopment of clinical trials.
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