新型冠状病毒肺炎疫情防控常态化下临床试验用药品规范化应用的策略与实践

Strategies and Practice of Standardized Application of Investigational Products Under the Normalization of Corona Virus Disease 2019 Epidemic Prevention and Control

关键词:  临床试验用药品  药物临床试验药房  新型冠状病毒肺炎疫情防控

Key words:  investigational products  drug clinical trial pharmacy  COVID-19 epidemic prevention and control

摘要:

目的 分析福建医科大学附属协和医院在新型冠状病毒肺炎疫情防控常态化下临床试验用药品应用情况，优化管理策略，为其他药物临床试验机构提供参考。方法 对试验用药品全流程中的关键环节和存在问题进行探讨分析，制定疫情相关防控措施并优化流程，对比优化前后1年间的试验用药品应用情况、差错事件数和工作效率。结果 影响试验用药品应用的主要因素是人员、环境、流程，通过明确职责、加强培训和健全制度进行了流程优化。优化后2020年药物临床试验药房承担160项临床试验的药品管理工作，涉及随访受试者总数897名，负责应用259种临床试验用药品，工作量与2019年（128项）相比增长显著，工作服务能力有效提高，药品相关的差错事件发生频次显著下降（P<0.01），获得了研究者、申办方、监管部门等的高度认可。结论 新型冠状病毒肺炎疫情未对该院临床试验用药品应用造成持续影响，专人专职采用优化后的流程使疫情下试验用药品的应用更为规范，可保障受试者的用药安全，提高药物临床试验质量。

Abstract:

OBJECTIVE To analyze the application of investigational products in Fujian Medical University Union Hospital under the normalization of corona virus disease 2019(COVID-19) prevention and control, to optimize existing management strategies and to provide reference for other clinical drug trial institutions. METHODS The key links and existing problems in the overall process of investigational product application were discussed and analyzed, formulating epidemic prevention and control measures and optimizing procedures. The application of investigational products, number of error events and work efficiency were compared in one year before and after optimization. RESULTS The main factors affecting the application of investigational products were personal, environmental and procedural factors. Process optimization was carried out by clarifying responsibilities, strengthening training and perfecting guidelines. After the optimization, drug clinical trial pharmacy became responsible for the drug management of 160 clinical trials in 2020, involving a total of 897 follow-up subjects, and responsible for the application of 259 kinds of investigational products. Compared with the 128 items in 2019, the work capacity continued to increase, and drug-related error events were significantly decreased(P<0.01), and work service efficiency had been effectively improved. These have received high praise from investigators, sponsors and the government regulator. CONCLUSION The COVID-19 epidemic has not had a lasting impact on the application of investigational products. The optimized procedures are used by dedicated personnel to standardize the use of investigational products under the epidemic situation, which can ensure the drug use safety on subjects and improve the quality of clinical trials.