药物临床试验机构监督检查常见问题及监管建议

Common problems and suggestions in the supervision and inspection of drug clinical trial institutions

目的 总结药物临床试验机构在日常监督检查中发现的突出问题,探讨提高监管效能的方法。方法 对2023年度湖南省药品审核查验中心药物临床试验机构日常监督检查报告进行梳理,针对突出问题做出汇总和分析。结果 研究者在研项目过多,项目质量难保证;研究者过度依赖临床协调员,难以正常履行职责;申办方专业水平不强,方案设计能力不足。结论 监管部门应根据省内实际情况,加强事中事后监管和风险研判能力,可通过加强法规宣贯,严格依法监管;加强问题处置,实施整改跟踪;加强能力建设,实行动态管理提高对机构的监管能力。

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.