临床试验实施中方案偏离及方案违背的分析研究

Analysis and research on program deviation in the implementation of clinical trials

目的分析临床试验中发生方案偏离/方案违背(PD/PV)的原因及种类,有针对性制定预防该类偏离发生的措施,更好的提高临床试验质量。方法对本院进行的17项临床试验中发生的PD/PV类型进行统计分析,查找相关原因,并提出改进措施。结果访视超窗发生率、进餐、用药超窗以及失访发生率高于其他(P<0.05);无专职研究人员参与发生PD/PV的概率明显高于其他各组(P<0.05);有专业临床研究协调员(CRC)及科室质控人员组发生PD/PV的概率明显高于有专职研究人员组(P<0.05);发生的三类主要方案偏离中,有专职研究人员、有CRC及科室质控人员组发生PD/PV的病例比率远远小于无专职研究人员参与组比率(P<0.05);有专职研究人员参与组相比有CRC及科室质控人员参与组,发生PD/PV的病例比率差异不明显(P>0.05)。结论访视、进餐和用药超窗以及失访等是PD/PV的常见类型;专职研究人员、CRC及科室质控人员的参与等可降低PD/PV的发生。因此建议在临床试验中增加专职研究人员、CRC和科室质控人员的参与度,同时还应加强研究人员的培训和伦理审查的力度,从而达到提高临床试验质量的目的。

Objective To analyze the reasons of program deviation(PD/PV)in clinical trials and summarize the mea⁃sures to prevent such deviation so as to improve the quality of clinical trials.Methods Statistically analyze the types of PD/PV in 17 clinical trials conducted in our hospital and find out the related reasons to propose improvement measures.Results The visits beyond the prescribed time range had statistically significant difference with other reasons for deviation(P<0.05).Eating and taking medicine beyond the prescribed time range and loss to follow-up had statistically significant difference with other reasons for deviation(P<0.05).Non-full-time researchers participating had higher probability of PD/PV than that of other groups,and the difference was statistically significant(P<0.05).The probability of PD/PV in the group with CRC and department quality control personnel was significantly higher than that in the group with full-time researchers,and the difference was statistically significant(P<0.05).Among the three main types of deviations,the incidence of PD/PV in the group with full-time researchers,CRC and department quality control personnel is much lower than that in the group with⁃out full-time researchers(P<0.05).There was no significant difference in the incidence of PD/PV between the group with full-time researchers and the group with CRC and department quality control personnel(P>0.05).Conclusion Visiting,eating and taking medicine beyond the prescribed time range and loss to follow-up are common reasons for PD/PV.The par⁃ticipation of full-time researchers,CRC and department quality control personnel had effect on the occurrence of PD/PV.Therefore,it is suggested to increase the participation of full-time researchers,CRC and department quality control person⁃nel in clinical trials,at the same time,researchers’training and ethical review should also be strengthened so as to improve the quality of clinical trials.