目的: 了解山西省药物临床试验机构的发展现状,为推动本省药物临床试验健康可持续发展提供参考。方法: 通过登录药物临床试验机构备案管理信息平台和药物临床试验登记与信息公示平台,收集山西省药物临床试验机构的相关数据,从机构数量、地域分布、专业种类、主要研究者数量、承接项目数量和完成情况等方面进行统计分析。结果与结论: 自实施备案制以来,山西省药物临床试验机构数量增至35家,增幅为75.0%,主要分布在太原、长治、晋城、大同、临汾、晋中、运城等;涉及的专业种类由50个增至112个,增幅为124%;承接药物临床试验项目由868项增至3822项,增幅为240.3%。备案制实施后,山西省药物临床试验机构发展形势良好,对新药的创制作出了积极贡献,但是各区域药物临床试验机构数量和承接临床试验项目数量存在发展不均衡的现象,仍有多数医疗机构具备条件未申请备案,以及Ⅰ期药物临床试验研究资源利用率不高等情况,建议政府部门出台相应政策支持有条件的医疗机构参与机构备案,同时医疗机构内部须重视临床试验质量,提升技术水平,优化试验流程,提高工作效率,制定合理的收费标准,助力项目落地,共同推动本省药物临床试验稳步健康发展。

Objective: To understand the current development situation of drug clinical trial institutions in Shanxi Province, and to provide references for promoting the healthy and sustainable development of drug clinical trials in our province. Methods: The relevant data on drug clinical trial institutions in Shanxi Province were collected by logging into the drug clinical trial institution registering management information platform and the drug clinical trial registration and information publicity platform, and the statistical analyses were conducted from the aspects of institution number, regional distribution, professional categories, number of main researchers, number of projects undertaken, and completion status. Results and Conclusion: Since the implementation of the registering system, the number of drug clinical trial institutions in Shanxi Province has increased to 35, with a growth rate of 75.0%, mainly distributed in Taiyuan, Changzhi, Jincheng, Datong, Linfen, Jinzhong, Yuncheng, etc. The number of professional categories involved has increased from 50 to 112, with a growth rate of 124%. The number of drug clinical trial projects undertaken has increased from 868 to 3822, with a growth rate of 240.3%. After the implementation of the registering system, the development situation of drug clinical trial institutions in Shanxi Province is good, which has made positive contributions to the creation of new drugs. However, there is an imbalance in the number of drug clinical trial institutions and the number of clinical trial projects undertaken in various regions, and there are still many medical institutions that meet the conditions but have not applied for institutional registration, and the utilization rate of research resources for phase Ⅰ drug clinical trials is not high. It is recommended that government departments should introduce corresponding policies to support eligible medical institutions to participate in institutional registration. At the same time, medical institutions should pay attention to the quality of clinical trials, enhance the level of technology, optimize trial processes, improve work efficiency, formulate reasonable fee standards, assist in project implementation, and jointly promote the steady and healthy development of drug clinical trials in our province.