[關(guān)鍵詞]
[摘要]
2020年初始新型冠狀病毒肺炎(COVID-19)疫情爆發(fā),國(guó)家經(jīng)濟(jì)和人民生活受到重創(chuàng),臨床試驗(yàn)行業(yè)深受影響,也給研究機(jī)構(gòu)管理和試驗(yàn)項(xiàng)目實(shí)施帶來前所未有的挑戰(zhàn)。通過分析各大研究機(jī)構(gòu)針對(duì)COVID-19防控要求下的應(yīng)對(duì)措施,選取2020年1月23日至2020年4月8日,整理出本研究中心試驗(yàn)進(jìn)展情況、處理方式、隨訪用藥、脫落失訪等情況,探討疫情期間降低臨床試驗(yàn)影響的可行性方法,旨在為今后探索臨床試驗(yàn)的遠(yuǎn)程執(zhí)行積累經(jīng)驗(yàn),為建立特殊時(shí)期臨床試驗(yàn)應(yīng)對(duì)策略提供參考依據(jù)。
[Key word]
[Abstract]
At the beginning of 2020, with the outbreak of the nationspread coronavirus pneumonia (COVID-19), the national economy and people's lives have been deeply affected, as well as the clinical trial industry, which has brought unprecedented challenges to the management of research institutions and the implementation of clinical trial projects. This study analyzes the measures of chinese major research institutions in response to the requirements of the prevention and control of new coronavirus pneumonia. We select 76-day of 2020.01.23-2020.04.08 as time frame, to sum up the ongoing projects, treatment methods, followup medications, and loss of follow-ups of our research center, and aim to explore the feasibility of reducing the impact of clinical trials during the epidemic, as well as to accumulate experience for the remote execution of clinical trials in the future, and provide a reference for establishing relevant strategy for clinical trials under a special circumstance.
[中圖分類號(hào)]
[基金項(xiàng)目]