构建药物临床试验高效运行管理模式的实践与探讨

Practice and Discussion on Constructing Effective Operation and Management Model of Drug Clinical Trials

目的探索药物临床试验机构管理模式,保证药物临床试验高效运行。方法以临床试验项目数、启动速度为评价指标,评价机构管理模式效果。结果2013年至2021年我院临床试验数量位居全国前列。1年内项目启动率由2019年的77.2%提高到2020年的90.2%,启动前期中位时间由2019年的128天缩短至2020年的88天,差异有统计学意义。国家药品监督管理局核查项目均通过,促进新药上市。结论我机构从全面质量管理理念的“人、机、料、法、环”5个方面进行管理模式优化,规范了临床试验行为,使临床试验高效运行。

Objective To explore the management mode of drug clinical trial institutions and ensure the efficient operation of drug clinical trials.Methods The number of clinical trial projects and the start speed were used as the evaluation indicators to evaluate the effect of institutional management mode.Results From 2013 to 2021,the number of clinical trials in our hospital ranked among the top in the country.The project initiation rate increased from 77.2%in 2019 to 90.2%in 2020 within one year,and the median time in the early stage of initiation shortened from 128 days in 2019 to 88 days in 2020,with a statistically significant difference.The verification projects of the National Medical Products Administration have been passed to promote the listing of new drugs.Conclusion Our institution optimized the management mode from the five aspects of"man,machine,material,method and environment"of the total quality management concept.It standardized the clinical trial behavior,and made the clinical trial run efficiently.