药物临床试验质量影响因素分析及对策探讨

Analysis and countermeasures of influencing factors on quality in drug clinical trials

目的分析影响临床试验质量的因素,探讨提高临床试验质量的对策。方法收集汇总本院2015-2017年药物临床试验项目的质量控制/检查情况。根据发现问题的可能性和严重性综合评估试验项目质量,分别采用单因素和回归分析进行试验质量的影响因素分析。结果汇总73项临床试验项目质量检查情况,共发现质量问题337个,其中一般问题240个(71.2%),重要问题92个(27.3%),严重问题5个(1.5%)。对73项试验项目进行综合评估,高危项目有10项(14%),中危项目有31项(42%),低危项目有32项(44%)。单因素分析显示研究团队经验、有无专职人员管理、有无专业临床试验协调员(CRC)参与、 CRC整体情况、受试者来源和试验周期对临床试验质量有显著影响(P <0.05)。Ordinal回归分析显示,有无专职人员管理是试验质量的主要影响因素。结论研究团队经验和专职情况、 CRC的参与以及受试者来源会影响试验质量,加强研究人员培训、实行专业化专人管理、教育受试者并提高其依从性等措施有利于试验质量提升。

AIM To analyze the influencing factors on the quality of clinical trials,and explore the strategies for improving quality.METHODS We collected and summarized the quality control/check findings of clinical trials in our hospital from 2015 to 2017.Qualities of clinical trials were evaluated according to the likelihood and severity of findings.Single factor and Ordinal regression analyses were used for data analysis.RESULTS There were 337 findings in the 73 projects,and 240 findings(71.2%)were minor,92 findings(27.3%)were major,5 findings(1.5%)were critical.Comprehensive evaluation of the 73 projects showed that10 projects(14%)were high risk,31 projects(42%)were middle risk,and 32 projects(44%)were low risk.Results from the single factor analysis showed that factors as research team experience,full-time status,clinical research coordinator(CRC)participation,general situation of CRC’s work,subject source and study period had statistical significances(P<0.05)for quality of clinical trial.Data from Ordinal regression showed that the full-time status was the main influencing factor.CONCLUSION Research team experience and full-time status,CRC participation,and subject source may affect quality of clinical trial.Strengthening training of clinical study teams,equipping full-time researchers and CRC,strengthening the management and education of the subject can improve the quality of clinical trial.