陕西省药物临床试验机构现状分析及对策研究OA

Objective To investigate the current development status of drug clinical trial institutions(hereinafter referred to as institutions)in Shaanxi Province,and to provide reference for the management of related institutions in China.Methods A total of 44 institutions in Shaanxi Province that had completed filing on the Drug Clinical Trial Institution Filing Management Information Platform before December 31,2024 were selected as the research subjects.Questionnaires were distributed,and eight institutions were randomly sampled for on-site visits.Multi-dimensional analyses were conducted on the construction status of institutions and the current status of trial implementation.Results The number of filed institutions in Shaanxi Province grew rapidly,mainly concentrated in Xi'an City(31 institutions,70.45%),with tertiary hospitals being the majority(42 institutions,95.45%).The institutional office was independently established in 19 institutions(43.18%),and the ethics office was independently established in 20 institutions(45.45%).Institutional staffing basically met daily needs,while ethics staffing was relatively weak.From 2020 to 2024,the number of drug clinical trial projects undertaken in the province showed a fluctuating upward trend,peaking in 2022(937 projects),with phase Ⅱ and phase Ⅲ drug clinical trials being the main types,and phase Ⅰ drug clinical trial research capacity being weak.The development of institutions was uneven,newly established institutions undertook few trials,and some well-established institutions showed low participation in high-quality trials.On-site visit research revealed that the main problems of institutions included weak institutional construction,insufficient staff capacity,and lack of supporting support.It is recommended to unify standards,implement hierarchical management,and strengthen targeted training.Conclusion The overall level of institutions in Shaanxi Province needs to be improved.Enhancements can be made by introducing supporting incentive policies,strengthening institutional self-construction,and innovating regulatory approaches to promote high-quality development.