受试者招募工作关乎临床研究质量与进度。无法按计划招募到合适的受试者,一直是研究者发起的临床研究（IIT）开展过程中面临的主要挑战之一。本文分析影响IIT项目受试者招募进度的常见因素,并借鉴国内外经验,从提高受试者认知度与信任度、拓宽招募渠道、加强人文关怀、建立多中心伦理协作审查机制等方面探讨推进受试者招募的具体措施,以期为IIT研究者及科研管理部门提供参考。

Recruitment of subjects is crucial to the quality and progress of clinical research．However,the inability to recruit suitable subjects according to the plan has been one of the major challenges faced by investigators in the process of conducting investigator-initiated trial（IIT）．This article analyzes the common factors that affect the recruitment progress of IIT projects,draws on domestic and international experiences,and explores specific measures to promote subject recruitment,including improving subject awareness and trust,expanding recruitment channels,enhancing humanistic care and establishing a multi-center ethical collaboration review mechanism,in order to provide reference for IIT researchers and research management departments．