新药临床试验远程监查实践初析

A preliminary analysis of remote monitoring practice in clinical trials

目的:总结新药临床试验远程监查实践经验,调查远程监查使用效果,探讨远程监查的优势及考量因素,为临床试验监查管理提供参考。方法:针对疫情期间存在不能按时现场监查的问题,我院利用数据处理与应用平台的技术及时上线远程监查系统供申办方使用。通过系统后台统计,截至2020年9月15日远程监查的使用情况,通过卡方检验比较远程监查和现场监查所发现的人均问题检出率差异以客观评价其应用效果。通过自制问卷与深度访谈调查远程监查系统使用体验与优缺点,并利用卫生经济学评价方法进行单纯现场监查模式、远程监查与现场监查结合模式的成本测算。结果:我院在2020年2月10日正式上线远程监查系统,截至2020年9月15日我院已有76个申办方/合同研究组织(CRO)、176位监查员(CRA)使用远程监查系统对我院16个科室、228个项目、1 318例受试者进行远程监查,使用系统总次数10 470次。228个项目的远程监查发现3 820条试验缺陷。与2019年同等项目现场监查对比显示,远程监查在核查方案违背、病例报告表(CRF)、合并用药、生物样本方面可达到现场监查的效果,在纸质资料较多的原始记录、知情同意、不良事件、试验药品方面不及现场监查。回收的168份自制问卷显示75%监查员对系统非常满意,72.61%CRA认为远程监查系统能够有效地支持完成监查工作,62.5%CRA认为可降低现场监查频率50%。16位CRA深度访谈显示远程监查受到业内好评。远程监查将单纯现场监查模式、远程监查与现场监查结合模式进行成本效益分析,结果显示通过远程监查与现场监查结合的方式,每个项目预计能够帮助降低16次监查频率,节约差旅费用73 600元,节约差旅时间成本624 h。远程监查需在系统验证、数据安全、受试者知情同意与隐私保护、实施等方面加以考虑与规范。结论:远程监查模式可使监查不受地域与时间限制,能及时发现试验的问题、极大提升监查效率,降低临床试验风险与成本,未来可在更多方面进行应用和探索,但尚需进一步补充数据源和在系统验证等方面进一步规范。

Objective: This study summarizes the practical experience of remote monitoring in clinical trials,preliminarily discusses the advantages and consideration factors,and provides reference for monitoring and management of clinical trials. Methods: In view of the problem that on-site monitor cannot be conducted on time during the COVID-19,our hospital launched the online remote monitoring system in time relying on the DPAP technology for the use of sponsor and CRO. The application of remote monitoring by September 15,2020 were counted through the system backstage. The effect of application was objectively evaluated by comparing the defect detection rate per subject found by remote monitoring and on-site monitoring with chi-square. The user experience,advantages and disadvantages of remote monitoring system were investigated through homemade questionnaire and in-depth interview.The method of health economics evaluation was used to estimate the cost of simple on-site monitoring mode,remote monitoring and on-site monitoring combined mode. Results: The hospital officially launched the remote monitoring system on February 10,2020. Until September 15,2020,176 CRAs from 76 sponsors/CRO have used the remote monitoring system for totally 10 470 times to conduct remote monitoring,involving 228 projects,1 318 subjects,16 departments in our hospital. A total of 3 820 findings have been found during the remote monitoring of 228 trials.Compared with the on-site monitoring of the same project in 2019,the remote monitoring achieved the on-site monitoring effect in terms of checking protocol deviation,case report form( CRF),combined drug use and biological samples;however,it is not as good as the on-site monitoring in terms of original records,informed consent,adverse events and experimental drugs,which involves more paper materials. 72. 61% of CRAs believed that remote monitoring system effectively supported the completion of monitoring work,and 62. 50% of CRAs thought that it reduced the time of on-site monitoring. The in-depth interviews with 16 CRAs showed that remote monitoring had advantages and was highly praised. The cost of the combination of routine on-site monitoring visit,remote monitoring and on-site monitoring was calculated,resulting that on-site monitoring visit frequency was reduced by 16 times,saving 73 600 RMB of travel expenses and 624 hours of travel time. But remote monitoring should be considered and standardized in system verification,subject informed consent monitoring and privacy protection,data security,implementation and other aspects. Conclusion: The remote monitoring mode made the monitoring free from location and time constraints,timely found the problems in the trials,greatly improved the efficiency of the monitoring,and reduced the risk and cost of clinical trials. In the future,it can be applied and explored in more aspects,but still needs to be further supplemented with data sources and standardized in the aspects of system verification.