疫苗臨床試驗通常由省級疾病預(yù)防控制中心作為負責機構(gòu)，在市、縣級疾病預(yù)防控制中心開展實施，為保證疫苗臨床試驗的質(zhì)量，省級疾病預(yù)防控制中心需建立完善的疫苗臨床試驗現(xiàn)場選擇及評估標準，對現(xiàn)場的硬件設(shè)施、軟件條件等進行評估。結(jié)合湖北省疾病預(yù)防控制中心近幾年在疫苗臨床試驗現(xiàn)場選擇及評估方面積累的經(jīng)驗，從疫苗臨床試驗現(xiàn)場選擇基本原則及考慮要點、現(xiàn)場評估要點、現(xiàn)場選擇及評估中存在的問題幾個方面入手，探討疫苗臨床試驗研究現(xiàn)場選擇及評估要點，以期為國內(nèi)同行提供借鑒與參考。

Vaccine clinical trials are usually conducted by the provincial centers for disease control and prevention, and carried out in municipal and county-level centers for disease control and prevention.In order to ensure the quality of vaccine clinical trials, the provincial centers for disease control and prevention needs to establish perfect site selection and evaluation standards for vaccine clinical trials, and evaluate the site hardware facilities and software conditions.Based on the experience in the selection of vaccine clinical trial sites in Hubei Provincial Center for Disease Control and Prevention, this paper discusses the key points of vaccine clinical trial research site selection and evaluation from the basic principles of vaccine clinical trial site selection, evaluation points and common problems in site selection and evaluation, in order to provide reference for peers.

R965.3

國家“重大新藥創(chuàng)制”科技重大專項—疫苗臨床評價技術(shù)平臺建設(shè)（2018ZX09734004）