药物Ⅰ期临床试验中受试者筛选失败及脱落原因分析探讨

The reasons for screening failure and dropping out of subjects in phaseⅠdrug clinical trials

目的:分析药物Ⅰ期临床试验中受试者筛选失败及脱落的常见原因,探讨提高筛选合格率及应对受试者脱落的方法对策。方法:收集自2017年11月至2019年1月开展并完成的药物Ⅰ期临床试验信息,统计参加筛选的志愿者的筛选失败原因,以及入选受试者的脱落原因。结果:研究纳入药物Ⅰ期临床研究13项,共筛选志愿者1629例次,筛选失败963例次,筛选失败率59.12%。筛选失败原因为实验室检查结果异常343例次(33.99%),除实验室检查外的其他检查结果异常224例次(22.20%),撤回知情同意215例次(21.31%),个人史符合排除标准122例次(12.09%),其他原因105例次(10.41%)。脱落7例次,脱落率1.05%。脱落原因为:因个人原因退出4例次,入住体检不合格1例次,不良事件2例次。结论:实验室检查结果异常、其他检查结果异常和撤回知情同意是志愿者筛选失败的主要原因。脱落原因多为不可控因素。降低筛选失败率和脱落率,深度知情和以保护受试者权益为出发点的过程管控是其中的关键环节。

Objective:To analyze the common reasons of screening failure and dropping out of subjects in phaseⅠdrug clinical trials,and to explore strategies to improve screening success rates and to avoid subjects’dropping out.Methods:Information on phase I drug clinical studies that were conducted and completed from November 2017 to January 2019 were collected,and the reasons for volunteers’screening failures,as well as dropping out reasons of enrolled subjects were analyzed.Results:13 phase I drug clinical studies were involved,in which 1629 volunteers were screened and 963 failed screening with a failure rate of 59.12%.The reasons for screening failure were abnormal laboratory results(343 cases,33.99%),abnormal examination results except for laboratory tests(224 cases,22.20%),withdrawal of informed consent(215 cases,21.31%),personal history fitting exclusion criteria(122 cases,12.09%)and other reasons(105 cases,10.41%).Besides,7 cases were dropped out with a dropping out rate of 1.05%.The reasons of dropping out were personal reasons(4 cases),abnormal result of hospitality examination(1 case)and adverse events(2 cases).Conclusion:Abnormal results of laboratory tests,abnormal results of other tests and withdrawal of informed consent are the main reasons for the failure of volunteer screening.Most of the reasons of dropping out are uncontrollable factors.Deep informed and the process control focusing on subject’s rights are the key link in reducing screening failure and dropping out rates.