新冠疫情下药物临床试验受试者管理优化

Optimization of Subject Management of Clinical Drug Trials during COVID-19 Pandemic

目的探讨新冠疫情下药物临床试验受试者管理优化策略。方法回顾性选取2020年1月至2020年10月某院新冠疫情防控下的药物临床试验受试者100例,依据管理优化策略分为信息化管理组(n=50)和常规化管理组(n=50),统计分析两组受试者的访视完成率、受试者依从性和满意度。结果信息化管理组的访视完成率显著高于常规化管理组(90.0%vs 72.0%,P<0.05)。信息化管理组受试者依从性高于常规化管理组(90.0%vs 64.0%,P<0.01)。信息化管理组受试者满意度显著高于常规化管理组(94.0%vs 74.0%,P<0.01)。结论新冠疫情下药物临床试验受试者信息化管理较常规化管理效果好。

Objective To explore the optimization strategy of drug clinical trial subject management under COVID-19 pandemic.Methods A total of 100 subjects in drug clinical trials under the COVID-19 prevention and control in our hospital from January 2020 to October 2020 were retrospectively selected and divided into the information management group(n=50)and the routine management group(n=50)according to the management optimization strategy.The visit completion rate,subject compliance and satisfaction of the two groups were statistically analyzed.Results The visit completion rate of the information management group was significantly higher than that of the routine management group(90.0%vs 72.0%,P<0.05).The compliance of subjects in the information management group was higher than that in the routine management group(90.0%vs 64.0%,P<0.01).Subjects’satisfaction in the information management group was significantly higher than that in the routine management group(94.0%vs 74.0%,P<0.01).Conclusion The informatization management of drug clinical trial subjects under COVID-19 is more effective than the routine management.