PDCA循环法在改进药物临床试验资料管理工作中的应用

The Application of PDCA Circulation Method in Improving the Management of Drug Clinical Trial Data

目的研究PDCA循环法在改进药物临床试验资料管理工作中的应用效果。方法比较PDCA循环法实施前(2018年9月—2019年6月)与实施后(2019年7月—2020年5月)药物临床试验资料完整性合格率。结果PDCA循环法实施后临床试验准备阶段资料完整性合格率虽比实施前高,但差异无统计学意义(P>0.05);实施后临床试验进行阶段、完成阶段的资料完整性合格率均为100.00%,比实施前的25.00%,41.67%高,差异有统计学意义(χ2=6.857、4.148,P<0.05)。实施前后问题较多项目资料完整性合格率进行比较,差异无统计学意义(P>0.05)。结论在改进药物临床试验资料管理工作中采用PDCA循环法有助于药物临床试验资料完整性的提高。

Objective To study the effect of PDCA circulation method in improving the management of drug clinical trial data.Methods To compare the pass rate of completeness of drug clinical trial data before the implementation of PDCA cycle method(September 2018 to June 2019)and after implementation(July 2019 to May 2020).Results After the implementation of the PDCA cycle method,the data integrity qualification rate of the clinical trial preparation stage was higher than before the implementation,but the difference was not statistically significant(P>0.05);after the implementation of the clinical trial and the data completeness pass rate at the stage and completion stage were both 100.00%,which were higher than the 25.00%and 41.67%before implementation,the difference was statistically significant(χ2=6.857,4.148,P<0.05).Compared the pass rate of data integrity of projects with many problems before and after implementation,the difference was not statistically significant(P>0.05).Conclusion The use of PDCA circulation method in improving the management of drug clinical trial data is helpful to improve the integrity of drug clinical trial data.