Development Status of Drug Clinical Trial Institutions in Anhui After the Implementation of the Filing System
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,phase Ⅰ clinical 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 1 415 drug clinical trial projects(30 instituions)had been completed,and 3 363(40 instituions)were in underway.There were eight institutions that simultaneously completed specialty filing of phase Ⅰ drug 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.
drug clinical trial institutionfiling systemAnhuidrug regulation
万方数据
维普
