儿科人群临床试验中对受试者疼痛管理的伦理考虑  

Ethical considerations for subject pain management in pediatric population clinical trials

作　　者：程金莲[1] 谭刚[2] 赵秀丽[3] 王小宁[4] 肖爽[1] 朱雪琦[1] 刘巧 曹彩 王少华 刘利军 王晓玲[7] 丁倩 曹诗琴 李挺[8] 陈志刚[9] 王美霞[10] 李思成 哈鹏程 张青松 CHENG Jinlian;TAN Gang;ZHAO Xiuli;WANG Xiaoning;XIAO Shuang;ZHU Xueqi;LIU Qiao;CAO Cai;WANG Shaohua;LIU Lijun;WANG Xiaoling;DING Qian;CAO Shiqin;LI Ting;CHEN Zhigang;WANG Meixia;LI Sicheng;HA Pengcheng;ZHANG Qingsong(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Pecking Union Medical College Hospital,Beijing 100730,China;Beijing Tongren Hospital,Capital Medical University,Beijing 100730,China;Institute of Geriatrics,General Hospital of PLA,Beijing 100853,China;Zhongguancun Jiutai Good Clinical Practice Union,Beijing 100027,China;Institute of Hematology,Blood Diseases Hospital,CAMS,Tianjin 300020,China;Beijing Children's Hospital Affiliated to The Capital Medical University,Beijing 100045,China;The Second Affliated Hospital of Wenzhou Medical University,Wenzhou 325027,China;Jishuitan Hospital,Beijing 100035,China;Beijing Youan Hospital,Capital Medical University,Beijing 100069,China;Baochuang Ruihai(Beijing)Technology Development Co.,Ltd.,Beijing 100015,China;CCBR(Beijing)Company Ltd.,Beijing 102206,China;Chengdu Hehui Pharmaceutical Technology Co.,Ltd.,Chengdu 611137,China)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]中国医学科学院北京协和医院,北京100730 [3]首都医科大学附属北京同仁医院,北京100730 [4]中国人民解放军总医院老年医学研究所,北京100853 [5]北京中关村玖泰药物临床试验技术创新联盟,北京100027 [6]中国医学科学院血液学研究所血液病医院,天津300020 [7]首都医科大学附属北京儿童医院,北京100045 [8]温州医科大学附属第二医院,浙江温州325027 [9]北京积水潭医院,北京100035 [10]首都医科大学附属北京佑安医院,北京100069 [11]宝创瑞海(北京)科技发展有限公司,北京100015 [12]西斯比亚(北京)医药技术研究有限责任公司,北京102206 [13]成都和惠医药科技有限公司,四川成都611137

出　　处：《药物评价研究》2021年第6期1201-1206,共6页Drug Evaluation Research

基　　金：国家“十三五”重大新药创制专项课题(2019ZX09734001);北京医学伦理学会科研课题(BMEA2021105)。

摘　　要：作为"临床试验中对受试者疼痛管理的伦理考虑"系列标准之一,主要论述《儿科人群临床试验中对受试者疼痛管理的伦理考虑》的起草背景、制定依据和适用范围,以及儿科人群临床试验中受试者疼痛等负担的来源和识别、在儿科人群临床试验方案设计和临床试验执行过程时使受试者疼痛最小化的措施,以期从伦理角度对儿科人群临床试验中受试者疼痛管理提出指导意见。其适用于伦理审查中对于儿科人群临床试验中受试者疼痛管理的伦理考虑,以及研究者制定临床试验方案和试验流程对儿科人群疼痛管理的关注。对临床试验中儿科人群疼痛予以更多关注,是保护儿科受试者权益的措施之一,有助于保障儿科临床试验顺利开展。As part of the " Ethical considerations for subject pain management in clinical trials " series, this paper mainly discusses the drafting background, formulation basis and application scope of the standard " Ethical considerations for subject pain management in pediatric population clinical trials", as well as the main source and identification of the burden of pain in pediatric clinical trials, measures to minimize pain in the design of clinical trial protocols and in the execution of clinical trials in pediatric populations, in order to provide guidance for pain management of subjects in pediatric clinical trials from the ethical perspective. It is applicable to the ethical consideration of pain management in clinical trials in pediatric population in ethical review, as well as the concern of researchers on pain management in the development of clinical trial protocol and trial procedure in pediatric. It is one of the measures to protect the rights and interests of pediatric subjects to pay more attention to the pain of pediatric subjects in clinical trials, which is helpful to ensure the smooth development of pediatric clinical trials.

关 键 词：临床试验 受试者 儿科人群 疼痛 风险 负担 伦理 标准 

分 类 号：R926[医药卫生—药学]