药物临床试验编盲工作存在的问题及改进建议  

Current problems and improvement suggestions in blinding of drug clinical trials

作　　者：张莹莹 李晶[1] 李元滨 赵子德[2] 李明[1] 杜渐[1] 杜雅薇[1] 吴圣贤[1] ZHANG Yingying;LI Jing;LI Yuanbin;ZHAO Zide;LI Ming;DU Jian;DU Yawei;WU Shengxian(Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Eye Hospital,China Academy of Chinese Medical Sciences,Beijing 100040,China)

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]中国中医科学院眼科医院,北京100040

出　　处：《药物评价研究》2024年第6期1372-1378,共7页Drug Evaluation Research

基　　金：重大新药创制科技重大专项(2017ZX09304019);北京中医药大学东直门医院2022科技创新专项(DZMKJCX-2022-013)。

摘　　要：编盲是药物临床试验的重要环节,可直接影响到临床试验盲法实施的质量。目前编盲工作存在的问题有参与各方责任明确,但监管尚有不及;参与人员的实际工作经验不足,缺乏系统培训;安慰剂制备质量参差不齐,存在较大破盲风险;编盲现场操作不规范,对编盲现场工作流程及细节不能充分把握,严重影响工作的质量和效率。基于编盲工作中存在的实际问题,提出具体建议:明确监管方,提高监管力度;强化责任意识,重视责任归属;明确人员分工,加强规范培训;适应工作需求,不断完善标准操作规程(SOP)。以期与同行探讨,共同推动编盲工作的标准化与规范化,从源头为临床试验盲法的开展奠定坚实的基础。Blinding is an important segment of drug clinical trials,which can directly affect the quality of clinical trial.The current problems of blinding are as follows:Responsibilities clearly of all participants but lack of supervision;due to lack of training,there is a significant difference in the abilities and experiences of the participants.There is a high risk of blinding failure cause of the quality of placebo preparation varies.The on-site operation of blinding is not standardized,which seriously affects the quality and efficiency of work.Based on the above issues,suggestions include:Clarifying regulatory authorities and increasing regulatory efforts,strengthening the sense of responsibility and attaching importance to the attribution of responsibility,clarifing personnel division of labor and strengthening standardized training,improving standard operating procedures(SOP)continuously in order to adapt working needs.The standardization process of the blinding requires peer communication.Supervision and responsibility are important guarantees for the high-quality blinding implementation in clinical trials.

关 键 词：药物临床试验 盲法实施 编盲工作 标准操作规程 规范培训 

分 类 号：R951[医药卫生—药学]