[关键词]
[摘要]
2019年末至今新型冠状病毒肺炎疫情在全球蔓延,造成严重的经济冲击和社会影响,对药物临床试验的开展也带来诸多困难与挑战。基于药物I期临床试验受试人群和流程的特殊性,引发了对在新型冠状病毒肺炎疫情影响下药物I期临床试验受试者管理的一些思考。提出从受试者招募、筛选、入住的不同阶段,到受试者宣教、饮食管理及不良事件观察等多方面的应对策略,旨在探讨如何在疫情防控常态化情况下,更好地保护受试者安全与权益,加强临床试验的风险控制,确保试验的顺利完成。
[Key word]
[Abstract]
Since the end of 2019, the spread of the corona virus disease 2019 (COVID-19) has caused serious economic shocks and social impacts. The development of clinical trials of drugs has also brought many difficulties and challenges. Based on the particularity of the population and process of the Phase I clinical trials of the drug, it caused us to think about the management of the subjects in the Phase I clinical trials under the influence of the COVID-19. It proposes various strategies from the different stages of subject recruitment, screening, and admission, to subject education, diet management, and observation of adverse events. It aims to discuss how to protect the safety and rights of subjects better under the normalization of epidemic prevention and control, strengthen the risk control of clinical trials, and ensure the successful completion of trials.
[中图分类号]
[基金项目]
国家“重大新药创制”科技重大专项(2017ZX09304002);上海市中医药专门人才计划项目(ZY3-RCPY-3-1059)