Analysis on the Filing and Supervising Status of Drug Clinical Trial Institutions in Guangdong Province
Objective:To Investigate the current situation of drug clinical trial institution filing,the implementation of drug clinical trials,and the supervision of drug clinical trial institutions in Guangdong province,so as to provide reference for supervision related work.Methods:The archival information of drug clinical trial institutions was extracted from the archival management information sys-tem.The number of drug clinical trials was collected through an electronic questionnaire.The data from supervision inspections of drug clinical trial institutions was sorted out and summarized.The relevant data were analyzed statistically from multiple dimensions.Results:As of December 31,2023,a total of 140 drug clinical trial institutions in Guangdong province were recorded,which were mainly class A tertiary public hospital,and a total of 118 specialties were recorded.The recorded drug clinical trial institutions distributed in 19 prefecture-level cities,of which the drug clinical trial institutions located in Guangzhou(accounting for 32%)undertook 78%of the drug clinical trials in Guangdong province.The supervision and inspection found that some institutions still have problems in organizational management,sense of responsibility and ethical review,and the new recorded institutions are particularly prominent.Conclusion:The implementation of the filing system of drug clinical trial institutions has promoted the release of drug clinical trial resources in Guangdong province,but highlighted the problems restricting the effective use of resources such as uneven technical level,unreasonable professional layout and unbalanced regional development.It is suggested that the regulatory authorities improve the regulatory mechanism by strength-ening guidance services,help improve the utilization efficiency of drug clinical trial resources,and further promote the healthy develop-ment of drug clinical trial institutions in Guangdong province.
Drug clinical trial institutionFilingDrug clinical trialSupervision
NETL
NSTL
万方数据
