机构层面探讨临床试验实施过程中盲态保持的管理

Institutional management of maintenance of blind during the implementation of clinical trials

盲法是临床试验中控制和避免测量偏倚的重要手段,作为临床试验数据现场核查中的重点关注问题,对临床试验结果至关重要。但针对于试验药物无法实现盲态的双盲临床试验或设立盲态评估人员的单盲临床试验中,临床试验机构存在着盲态保持流程/标准操作规程(SOP)制定不详细不完整甚至缺失、研究人员盲态保持的培训不足、机构质量管理人员盲态保持的介入关注力度不够等问题。本文以机构管理视角,结合本院实际情况,通过完善盲态设计并制订盲态保持SOP、加强研究者培训和提高研究者对盲态保持的认知度和责任感、落地并执行临床试验盲态保持流程和SOP以及强化机构对盲态实施的质量管理等方面进行探讨,以期为临床试验机构盲态保持管理提供借鉴。

Blindness is an important means of controlling and avoiding measurement bias in clinical trials.As a key concern in on-site verification of clinical trial data,it is crucial for clinical trial results.However,in double-blind clinical trials where the investigational drug cannot achieve blinding or in single-blind clinical trials where blinding evaluators are established,clinical trial institutions have issues such as incomplete or incomplete blinding maintenace procedure/standard operation procedure(SOP),insufficient training for researchers on blinding,and insufficient intervention and attention from quality management personnel on blinding.From the perspective of institutional management and combined with the actual situation of our hospital,this article explores the improvement of blind design and the development of blinding maintenance SOP,strengthening researcher training and increasing researchers awareness and sense of responsibility for blinding maintenance,implementing and implementing clinical trial blinding maintenance procedure and SOP,and strengthening the quality management of blinding implementation by institutions,in order to provide reference for maintenance management in clinical trial institutions.