药物临床试验受试者随访管理模式的初步探讨

Preliminary study on the follow-up management model of subjects in drug clinical trials

目的探讨不同的随访管理模式对临床试验项目执行情况的影响。方法选择某院两个临床试验项目,从入组的速度、项目执行过程的规范性、受试者依从性等方面进行比较。结果两个项目在知情同意书签署情况、临床试验药物管理情况、临床试验记录情况等方面比较,差异无统计学意义(P> 0.05)。在项目执行过程的规范性方面,模式B执行优于模式A;在项目基本同时启动的情况下,模式B对项目执行的进度优于模式A。结论在项目配置的专职研究助理协助下,采用全组研究医师共同参与随访模式,对项目管理有更好的把控。

Objective To explore the difference between different follow-up management modes of subjects in drug clinical trials.Methods 2 clinical trial projects were selected in our hospital for the study,compared with the speed of the group,the standardization of the project implementation processand the compliance of the subject.Results There were no statistically significant differences between two projects in informed consent signed situation and situation of drug clinical trials management,clinical trial record,but it was not in terms of the standardization of the project execution process-pattern B execution is superior to pattern A.At the same time,as the project started,pattern B is doing better than pattern A.Conclusion With the assistance of the full-time research assistant assigned by the project, the whole group of research doctors were adopted to participate in the follow-up mode,so as to have a better control over the project management.