新型冠状病毒肺炎疫情期间I期临床试验病房及受试者管理

目的 探讨在常态化疫情防控下,I期临床试验病房安全开展工作的重点和难点。方法 结合医院疫情防控的常态化管理,制定符合药物I期临床试验特征的病房和受试者管理流程,确保受试者和工作人员安全,保证临床试验顺利进行。具体措施为：深入学习新型冠状病毒肺炎防控相关知识;网格化管理病房;成立3人防疫工作小组;实时调整招募受试者的来源地;“二步骤”落实流行病学筛查;落实入院前新型冠状病毒抗体和核酸检测;加强受试者住院期间防控。结果 我院I期临床试验病房在2020年3—12月安全开展临床试验项目14项,总筛选1 638名,入组585名。试验全部完成且未发生新型冠状病毒感染。结论 在新型冠状肺炎疫情期间,我院I期临床试验通过采取完善防控管理体系、严格执行筛选入住流程和加强受试者管理等措施,保障了受试者和医护人员安全以及I期临床试验的顺利进行。

Ward and Subject Management of Phase I Clinical Trials during COVID-19 Epidemic

Objective To explore the important and difficult points in management of ward and subject in phase I clinical trials while adhering to regular epidemic prevention and control. Methods While adhering to regular epidemic prevention and control in our hospital, we implemented the management for the wards and subjects in phase I clinical trials to ensure the safety of subjects and medical staff. Epidemic prevention strategies included continuous learning about the prevention and therapy of COVID-19; grid management of the wards; establishment of a three-person epidemic prevention team; real-time adjustment of the source of subjects; “two-step” implementation of epidemiological screening; detection of COVID-19 antibody and nucleic acid before admission and strengthening the management of subjects during hospitalization et al. Results A total of 14 clinical trial projects screening 1,638 patients and enrolling 585 patients were conducted from March to December 2020. All the trials were completed and no COVID-19 infection occurred. Conclusion During the COVID-19 epidemic, measures including improving the prevention and control management system, strict implementation of the screening and admission and strengthening the management of subjects are conducive to the safety of subjects and medical staff and the smooth progress of the Phase I clinical trial.