循证视角下药物临床试验质量管理评价工具的开发思考

Considerations of the evaluating tools development for the quality management of drug clinical trials in the view of evidence-based perspective

申办者、药物临床试验机构、监管方均是药物临床试验质量管理的重要角色。申办者是药物临床试验质量的最终责任人,药物临床试验机构负责药物临床试验的运行管理,监管方负责对药物临床试验的监督管理。同时,申办者和药物临床试验机构还是药物临床试验质量管理的重要被评价对象。目前,药物临床试验各方均在积极探索科学的质量管理评价方式。受限于药物临床试验及其质量管理过程的复杂性,现有评价通常更关注硬件建设水平,对质量管理相关软实力评价的研究尚欠深入。本研究介绍现有的质量管理理念,从法规要求、学术研究等方面简要梳理我国药物临床试验质量管理评价的现状,从药物临床试验性质、药物临床试验管理模式、药物临床试验现场检查等维度分析药物临床试验质量管理评价面临的挑战,借鉴药品领域的质量管理体系理念,从循证决策的角度,探讨可行的药物临床试验质量管理评价策略。

Sponsor,drug clinical trial institution,regulation are all important for the quality management(QM)of drug clinical trials.Sponsor is ultimately responsible for the quality of drug clinical trial.Drug clinical trial institution is responsible for the operation management of drug clinical trial.Regulation is responsible for the supervision of drug clinical trials.Meanwhile,sponsor and drug clinical trial institution are also important evaluated objects for their QM.At present,the development of scientific methods for QM evaluation of drug clinical trial is attracting increasing interests.However,at present,the studies mainly focus on evaluating hardware construction levels other than managing abilities,partially due to the complexity of drug clinical trials.In this study,existing QM theories were summarized,the existing strategies were reviewed,and the evaluating challenges for QM were discussed.In the view of evidence-based decision-making,potential evaluation strategies were discussed based on the concept of quality management system in drug related fields.