| 王甜甜,杨芳芳,李思奇,简正阳.备案制下贵州省药物临床试验机构发展现状分析[J].中国药事,2024,38(7):763-767 |
| 备案制下贵州省药物临床试验机构发展现状分析 |
| Analysis on the Current Development State of Drug Clinical Trial Institutions inGuizhou Province under the Registering System |
| 投稿时间：2024-03-16 |
| DOI：10.16153/j.1002-7777.2024.07.006 |
| 中文关键词: 药物临床试验机构 机构备案制 药品监管 药物研究 |
| 英文关键词: drug clinical trial institutions institution registering system drug regulation drug research |
| 基金项目:贵州省市场监管局2021年质量发展项目（编号黔质量发展项目[2021]24号）；贵州省中医药、民族医药科学技术研究专项课题项目（编号 QZYY-2024-127） |
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| 中文摘要: |
| 目的：了解我国药物临床试验机构备案制实施后贵州省药物临床试验机构发展状况及存在的问题，并提出建议，希望为促进本省药物临床试验机构的发展和建设提供参考。方法：基于全国药物临床试验机构备案管理信息系统以及药物临床试验登记与信息公示平台的数据，对贵州省药物临床试验机构发展、备案机构数量和地域分布、备案专业、主要研究者、试验项目承接和完成情况、试验药物类型、I期临床试验等方面进行分析。结果与结论：施行备案制后贵州省药物临床试验机构有了进一步的发展，但我省药物临床试验机构总体水平偏低，建议有关部门加强对药物临床试验机构的经济支持和政策引导，成立专业委员会共享行业信息，联合周边省份建立培训基地，制定院内激励性政策，共同推动我省药物临床试验机构发展。 |
| 英文摘要: |
| Objective: To understand the current state of development and issues on drug clinical trial institutionsin Guizhou Province after the implementation of drug clinical trial institution registering system in China, andprovide suggestions, in order to provide references for supporting the development and construction of drugclinical trial institutions in Guizhou Province. Methods: The data was collected from the national drug clinicaltrial institution registering management information system platform and the drug clinical trial registration andinformation publicity platform. A statistical analysis was conducted on the aspects, such as development course,number, and regional distribution of drug clinical trial institutions in Guizhou Province, as well as the registeredprofession, the principal investigators, clinical trial undertaking and completion status, experimental drug species,and phase I clinical trial. Results and Conclusion: The drug clinical trial institutions in Guizhou Province hasdeveloped since the implementation of drug clinical trial institution registering system. Nevertheless, the totalnumber of drug clinical trials is still relatively low. It is suggested that relevant departments should enhance thefi nancial support and policy guidance for drug clinical trial institutions, form professional associations for sharingmanufacturing information, collaborate with adjacent provinces to build training facilities, and establish incentive schemes within the institution, in order to foster the development of our province's drug clinical trial institutions. |
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