临床试验过程中研究者应有判断和报告个例SUSAR的责任  

Study of Investigator′s Responsibility for Judgment on Individual Cases of SUSAR in Clinical Trials

作　　者：王大猷[1] WANG Dayou(Huashan Hospital Affiliated to Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院,上海200040

出　　处：《中国医药导刊》2023年第7期693-699,共7页Chinese Journal of Medicinal Guide

摘　　要：目的:探讨研究者在临床试验现场判断可疑且非预期严重不良反应(SUSAR)的职责。方法:从SUSAR的属性,论证其判断属于医学判断;从《药物临床试验质量管理规范》(GCP)对研究者资质的要求,论证研究者具备判断个例SUSAR的能力;从SUSAR对于受试者权益和安全的影响,研究者所在临床试验的位置以及利益冲突的处理原则,论证研究者判断个例SUSAR是合理的;从GCP总则的有关条款,论证研究者判断个例SUSAR是完全合规的;从GCP对研究者要求的其他条款,论证研究者有判断个例SUSAR的能力和责任是执行这些条款的必要条件。结果:研究者及其团队在临床试验现场判断个例SUSAR,合乎临床试验程序优化的要求,合乎受试者的权益和安全是临床试验考虑的首要因素的宗旨,合乎利益冲突的透明、公信力的处理准则,合乎作为研究者的临床医生始终有医学判断或临床决策责任的GCP总则,也与GCP对研究者的其他要求逻辑自洽。结论:临床试验的研究方案应阐明SUSAR的概念,应明确研究者负有在临床试验现场判断个例SUSAR的责任。Objective:To clarify the responsibility of investigators for the judgment on individual cases of suspected,unexpected serious adverse reactions(SUSAR)in clinical trial testing sites.Methods:From the attributes of SUSAR,we argued that its judgment belongs to medical ones.Based on the requirements of GCP for the qualification of investigators,we argued that investigators have the competency to judge individual SUSAR cases.From the influence of SUSAR on the rights,safety,and well-being of trial subjects,the location of the investigator in the clinical trial,and the principle of dealing with the conflict of interest,we argued that it is reasonable for the investigators to join the judgment of individual SUSAR cases.According to the relevant provisions of GCP general rules,we argued that investigators′judgment of individual SUSAR cases is fully compliant.Based on some other requirements of GCP for investigators,we argued that investigators have the competency to judge individual SUSAR cases is a necessary condition for carrying out.Results:Investigators and their team judge individual SUSAR cases at the site of clinical trials in line with the requirements of optimization of clinical trial procedures,in line with the principle that the rights,safety,and well-being of the subjects are the most important considerations and should prevail over the interests of science and society,in line with the principles of transparency and credibility in dealing with conflicts of interest,in line with the general rules of GCP that medical judgment or clinical decisions should always be the responsibility of a qualified physician,and is logical self-consistency with other requirements of GCP for investigators.Conclusion:The concept of SUSAR should be illuminated in the research protocol and the responsibility of the investigator to judge the cases of SUSAR at the clinical trial site should be clarified.

关 键 词：药物临床试验质量管理规范 可疑且非预期严重不良反应 研究者 药物警戒 

分 类 号：R95[医药卫生—药学]