广西药物临床试验发展情况分析

Development of Drug Clinical Trials in Guangxi Zhuang Autonomous Region

目的促进广西壮族自治区药物临床试验工作进一步发展。方法收集2018年至2021年国家药品监督管理局和药物临床试验登记与信息公示平台上药物临床试验相关数据,从机构建设、备案专业、承接项目数量及分期等方面对比备案制实施前(2018年至2019年)及实施后(2020年至2021年)广西壮族自治区药物临床试验的发展情况。结果备案制实施后,广西壮族自治区药物临床试验机构数量增幅为69.23%,承接的药物临床试验项目增幅为56.52%,承接项目专业由备案制实施前的34个增加为实施后的48个,覆盖面增加41.18%。结论备案制的实施有利于药物临床试验资源释放,但广西壮族自治区药物临床试验总体水平偏低,应进一步整合资源,发挥民族医药优势,储备临床试验专业人才,助力我国生物医药创新。

Objective To promote the further development of drug clinical trials in Guangxi Zhuang Autonomous Region.Methods The communal data related to drug clinical trials were collected from the National Medical Products Administration and the Drug Clinical Trial Registration and Information Disclosure Platform from 2018 to 2021 to compare the development of drug clinical trials in Guangxi Zhuang Autonomous Region before(from 2018 to 2019)and after(from 2020 to 2021)the implementation of the record-keeping system from the aspects of the establishment of drug clinical trial institutions,the majors of record-keeping drug clinical trial,the number and stages of drug clinical trial projects.Results After the implementation of the record-keeping system,the number of drug clinical trial institutions in Guangxi Zhuang Autonomous Region increased by 69.23%,the number of drug clinical trial projects increased by 56.52%,and the number of project majors increased from 34 to 48,and the coverage increased by 41.18%.Conclusion The implementation of the record-keeping system is conducive to the release of drug clinical trial resources,but the overall level of drug clinical trials in Guangxi Zhuang Autonomous Region is low.It is necessary to further integrate resources,give full play to the advantages of ethnic medicine,reserve clinical trial professionals,and assist the biomedical innovation in China.