疫情防控新常态下人体生物等效性试验受试者管理探讨

Discussion on Subject Management of Human Bioequivalence Trial under the New Normal of COVID-19 Epidemic Prevention and Control

目的:为保证新型冠状病毒肺炎(COVID-19)疫情防控常态化下,仿制药人体生物等效性试验的有序开展和试验质量,最大限度的保护受试者和研究者的安全,针对新常态下影响受试者管理的因素进行探讨。方法:以生物等效性试验流程中受试者管理关键环节为切入点,分别对COVID-19疫情防控新常态下受试者的招募、筛选、入住、出院、随访等阶段进行深入探讨。结果与结论:在保障受试者权益与安全的前提下,对COVID-19疫情后开展生物等效性试验受试者的管理流程和细节作出相应调整,从而有效的保证了受试者安全和试验质量,提高了特殊公共卫生事件下生物等效性试验受试者管理的水平。

Objective: To discuss the factors influencing the management of subjects under the new normal period in order to ensure the order carrying out and quality of the bioequivalence trials and to protect the safety of subjects and researchers after the outbreak of COVID-19. Methods: Based on the five stages of subject management in bioequivalence trial process,this paper discussed the recruitment,screening,admitting,discharging and follow-up of subjects under the new normal of epidemic prevention and control. Results & Conclusion: On the premise of protecting the rights and interests and safety of subjects,the management process and details of subjects should be adjusted in order to guarantee the safety of subjects and test quality effectively,and improve the management level of subjects under special public health events.