Ⅰ期临床试验健康受试者管理出现的问题及对策探讨

Discussion on common problems of healthy subjects management in phase Ⅰ clinical trials

标准化的受试者管理是确保受试者安全和试验结果科学可信的基础。本文从Ⅰ期临床试验过程中健康受试者管理出现的一些问题出发,结合具体工作经验,探讨健康受试者管理的措施,提高受试者管理效率以及Ⅰ期药物临床试验质量。

Standardized subjects management is the basis to ensure the safety of subjects and the scientific credibility of trial results. Based on the work experience of Phase Ⅰ Unit of Peking University First Hospital,we discussed some problems and measures of healthy subjects management to improve the efficiency of healthy volunteers management and the quality of phase Ⅰ drug clinical trials.