备案制后安徽省药物临床试验机构发展现状分析

Development Status of Drug Clinical Trial Institutions in Anhui After the Implementation of the Filing System

目的分析安徽省药物临床试验机构发展现状。方法检索2019年12月1日至2023年7月31日(备案管理制实施后)药物临床试验机构备案系统及药物临床试验登记与信息公示平台,提取安徽省药物临床试验机构相关数据,分析各机构的发展现状、地域分布、备案专业、主要研究者、Ⅰ期临床试验等相关情况。结果安徽省备案成功的药物临床试验机构数量呈稳定上升趋势(由0家增至48家),其中2022年新增备案成功的药物临床试验机构最多(新增18家);16个地级市均分布有药物临床试验机构,其中合肥市最多(19家),芜湖市和阜阳市次之(各4家)。完成备案的48家机构中有14家是安徽省高等院校直属附属医院;备案专业共382个,其中西医专业371个(97.12%),中医专业11个(2.88%);备案专业数量以肿瘤科、呼吸内科、内分泌科、心血管内科较多(均不少于20个),以安徽医科大学第二附属医院最多(47个);涉及主要研究者756人,集中分布于安徽医科大学附属医院(163人、21.56%),蚌埠医学院附属医院(160人、21.16%)等单位;已完成的和正在开展的药物临床试验项目分别有1415项(30家)和3363项(40家);同时完成Ⅰ期药物临床试验专业和生物等效性试验专业备案的机构共8家。结论安徽省药物临床试验机构整体发展良好,但仍存在新增机构承接项目偏少,制度流程不规范,职业化、专业化的专职技术人才不足等问题,建议由成熟的大型医疗机构牵头建设区域性药物临床试验管理规范专科联盟,整合相关优质资源;不断完善机构相关管理制度及标准操作过程;出台针对药物临床试验平台和人才队伍建设的鼓励措施。

Objective To analyze the development status of drug clinical trial institutions in Anhui.Methods The relevant data of drug clinical trial institutions in Anhui from December 1,2019 to July 31,2023(after the implementation of the filing management system)were extracted from the drug clinical trial institution filing system and drug clinical trial registration and information disclosure platform,the development status,regional distribution,filing specialties,main researchers,phaseⅠclinical trials and other relevant information of each institution was analyzed.Results The quantity of drug clinical trial institutions that had completed filing in Anhui increased steadily(from 0 to 48 institutions),with the largest quantity of newly-added drug clinical trial institutions that had completed filing in 2022(18 institutions).All 16 prefecture-level cities had established drug clinical trial institutions,with Hefei having the most(19 institutions),followed by Wuhu and Fuyang(four in each city).Among the 48 institutions that had completed the filing,14 were the directly affiliated hospitals of Anhui's colleges and universities.There were 382 filing specialties,including 371(97.12%)in western medicine and 11(2.88%)in traditional Chinese medicine.The filing specialties mainly involved oncology,respiratory medicine,endocrinology and cardiovascular medicine departments(all no less than 20 specialties),and the Second Hospital of Anhui Medical University having the most(47 specialties).A total of 756 main researchers were involved,mainly in the affiliated hospitals of Anhui Medical University(163 researchers,21.56%),affiliated hospitals of Bengbu Medical University(160 researchers,21.16%)and other institutions.A total of 1415 drug clinical trial projects(30 instituions)had been completed,and 3363(40 instituions)were in underway.There were eight institutions that simultaneously completed specialty filing of phaseⅠdrug clinical trials and bioequivalence trials.Conclusion The overall development of drug clinical trial institutions in Anhui is good,but there are still problems,for example,the projects undertaken by newly-added institutions are few,the institutional processes are not normative,and the professional and specialized full-time technical talents are insufficient.It is suggested that mature large medical institutions should take the lead in establishing regional drug clinical trial management specialist alliances and integrate relevant high-quality resources;institutional management systems and standard operating procedures should be continuously improved;incentive measures for the construction of drug clinical trial platforms and talent teams should be issued.