药物临床试验受试者筛选失败原因浅析及对策探讨

Analysis and countermeasures of subjects' screening failure in drug clinical trials

目的分析临床试验受试者筛选失败的主要原因,探讨提高临床试验受试者筛选成功率的对策。方法回顾性分析贵州医科大学附属医院2013年1月至2016年10月期间的药物临床试验项目受试者筛选入选表,与临床试验研究者、临床研究协调员、监查员和受试者交流访谈,了解筛选失败的主要原因分布情况,并探讨提高筛选成功的策略。采用SPSS 19.0统计软件对数据进行频数和百分比的描述。结果收集47个药物临床试验项目数据,共筛选受试者958例,筛选失败182例,筛选失败率19.0%。其中,35例(19.2%)受试者因实验室指标不符合入选和排除标准,54例(29.7%)因体检结果 (不含实验室指标)不符合入选和排除标准;48例(26.4%)受试者入组前撤回知情同意书;40例(22.0%)受试者在导入期导入失败;5例(2.8%)受试者因其他原因筛选失败。结论不符合入选标准或符合排除标准、受试者撤回知情同意书及导入期导入失败是受试者筛选失败的重要原因。制定科学合理的入选和排除标准、采取措施减少受试者撤回知情同意书的情况,有助于提高受试者筛选成功率。

AIM To analyze the main reasons for screening failure of subjects in clinical trials, and explore the strategies for improving the success rate of screening. METHODS Retrospective analysis was conducted on subject screening and enrollment logs of drug clinical trials in Affiliated Hospital of Guizhou Medical University from January 2013 to October 2016. Interviews were taken with investigators, clinical research coordinators, clinical trial assistants and subjects. We explored the distributions of the main reasons screening failure and the strategies to improve the success of screening. SPSS 19.0 statistical software was used to describe the frequency and percentage. RESULTS The data of forty-seven drug clinical trials and nine hundred and fifty-eight subjects were involved. One hundred and eighty-two（19.0%） involved subjects were screening failed. Among them, thirty-five（19.2%） subjects were screening failed for laboratory indicators and fifty-four（ 29.7%） subjects for physical examination results except laboratory indicators. Forty-eight（ 26.4%） subjects withdrew informed consent forms before enrolling the clinical trials. Forty（ 22.0%） subjects were screening failed in run-in period. Five（ 2.8%） subjects were screening failed for other reasons. CONCLUSION Inconformity of the inclusion criteria or exclusion criteria, withdrawal of informed consent forms and failure during run-in period are the important reasons for the failure of screening. Developing scientific inclusion/exclusion criteria and reducing the withdrawal of informed consent forms will help to increase the success rate of screening.