2019年末至今新型冠狀病毒肺炎疫情在全球蔓延，造成嚴(yán)重的經(jīng)濟沖擊和社會影響，對藥物臨床試驗的開展也帶來諸多困難與挑戰(zhàn)。基于藥物I期臨床試驗受試人群和流程的特殊性，引發(fā)了對在新型冠狀病毒肺炎疫情影響下藥物I期臨床試驗受試者管理的一些思考。提出從受試者招募、篩選、入住的不同階段，到受試者宣教、飲食管理及不良事件觀察等多方面的應(yīng)對策略，旨在探討如何在疫情防控常態(tài)化情況下，更好地保護受試者安全與權(quán)益，加強臨床試驗的風(fēng)險控制，確保試驗的順利完成。

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.

國家“重大新藥創(chuàng)制”科技重大專項（2017ZX09304002）；上海市中醫(yī)藥專門人才計劃項目（ZY3-RCPY-3-1059）