浅析儿科人群药物临床试验的风险管理  

Risk Management of Pediatric Drug Clinical Trials

作　　者：彭诗荣 陈海燕[1] 王谦 丁倩 王晓玲 PENG Shirong;CHEN Haiyan;WANG Qian;DING Qian;WANG Xiaoling(Children's Hospital Affiliated to Zhengzhou University,Henan Children's Hospital,Zhengzhou Children's Hospital,Zhengzhou Henan 450018,China;Clinical Research Center,Beijing Children's Hospital Affiliated to The Capital Medical University,National Center for Children's Health,Beijing 100045,China)

机构地区：[1]郑州大学附属儿童医院,河南省儿童医院,郑州儿童医院药学部,河南郑州450018 [2]国家儿童医学中心,首都医科大学附属北京儿童医院临床研究中心,北京100045

出　　处：《中国药物警戒》2020年第9期564-566,571,共4页Chinese Journal of Pharmacovigilance

基　　金：科技部“重大新药创制”科技重大专项“儿童示范性新药临床评价技术平台建设”(2017ZX09304029)。

摘　　要：目的为儿科人群药物临床试验风险管理提供参考。方法借鉴风险管理的理论,查阅文献,结合实际工作经验,总结儿科人群药物临床试验风险因素和风险控制措施。结果从临床试验项目评估风险,比如研究者手册有幼年动物的实验结果,有成人数据和国外儿童数据等;申办者风险管理;专业团队风险管理,比如主要研究者具有丰富的儿科临床经验;临床试验实施风险管理;试验用药品和生物样本风险管理及系统风险管理中进行风险识别和风险评估,通过风险规避;风险减轻,比如加强临床试验质量控制和加强临床试验机构管理;风险转移,比如购买保险、明确合同的赔偿和权益保护条款等措施进行风险控制。结论通过对儿科人群药物临床试验风险因素进行风险识别和评估,采取相应的措施进行风险管理,从而减少和避免临床试验风险的发生,保护受试者和研究者的权益。Objective To provide reference for pediatric drug clinical trial risk management.Methods Based on the theory of risk management,literature review and practical work experience,the risk factors and risk control measures of pediatric drug clinical trials were summarized.Results Risk identification and risk assessment are carried out from project assessment risk,such as Investigator's Brochure with results from young animals,data of adult and foreign children;Sponsors manage risk;Manage risks from professional teams,such as principal investigators with extensive pediatric clinical experience;the implementation risk of clinical trials,the management risk of Investigational Medical Product and biological sample,as well as the management system risk.Through risk aversion;Risk mitigation,such as enhanced quality control of clinical trials and enhanced management of clinical trial institutions;Risk transfer,such as the purchase of insurance,clear contract compensation and rights protection clauses and other measures to control the risk.Conclusion Through risk identification and assessment of risk factors in pediatric drug clinical trials,corresponding measures are adopted for risk management,so as to reduce and avoid the occurrence of clinical trial risks and protect the rights and interests of subjects and Investigators.

关 键 词：儿科人群药物临床试验 风险识别 风险控制 

分 类 号：R95[医药卫生—药学]