Common problems and suggestions in the supervision and inspection of drug clinical trial institutions
Objective To summarize the main problems in the daily supervision and inspection of drug clinical trial institutions,and to improve the regulation efficiency.Methods We analyzed the daily supervision and inspection reports from drug clinical trial institutions of Hunan Drug Inspection Center in 2023,and summarized the prominent problems.Results Some research groups had quite many simultaneous projects under research,so the quality of the projects might be difficult to guarantee.Researchers relied too much on clinical research coordinators to perform duties normally.Some sponsors showed poor professionalism and insufficient scheme design ability.Conclusion The regulation department should strengthen the supervision and the risk assessment capacity,and reinforce implementation of laws and regulations.Meanwhile,they need to focus on the problem solving,rectification and tracking.Moreover,they should emphasize capacity building,and dynamically manage the supervision of the institutions.
drug clinical trial institutiondaily supervision and inspectionregulatory supervision and inspectionrecommendation
NETL
NSTL
万方数据
