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 clinical trials

作　　者：程金莲[1] 谭刚[2] 赵秀丽[3] 王小宁[4] 朱雪琦[1] 肖爽[1] 刘巧 曹彩 王少华 刘利军 王晓玲[7] 丁倩 哈鹏程 曹诗琴 李挺[9] 陈志刚[10] 李思成 王美霞[12] 张青松 CHENG Jinlian;TAN Gang;ZHAO Xiuli;WANG Xiaoning;ZHU Xueqi;XIAO Shuang;LIU Qiao;CAO Cai;WANG Shaohua;LIU Lijun;WANG Xiaoling;DING Qian;HA Pengcheng;CHAO Shiqin;LI Ting;CHEN Zhigang;LI Sicheng;WANG Meixia;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;CCBR(Beijing)Company Ltd.,Beijing 102206,China;The Second Affliated Hospital of Wenzhou Medical University,Wenzhou 325027,China;Jishuitan Hospital,Beijing 100035,China;Baochuang Ruihai(Beijing)Technology Development Co.,Ltd.,Beijing 100015,China;Beijing Youan Hospital,Capital Medical University,Beijing 100069,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]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]西斯比亚(北京)医药技术研究有限责任公司,北京102206 [9]温州医科大学附属第二医院,浙江温州325027 [10]北京积水潭医院,北京100035 [11]宝创瑞海(北京)科技发展有限公司,北京100015 [12]首都医科大学附属北京佑安医院,北京100069 [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2期298-304,共7页Drug Evaluation Research

基　　金：国家“十三五”重大新药创制专项课题(2019ZX09734001)。

摘　　要：论述《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,以及临床试验中疼痛的主要来源,临床试验中对受试者疼痛管理的伦理一般考虑和临床试验中试验操作程序引起的受试者疼痛等负担的伦理考虑等,以期从伦理角度对临床试验中受试者疼痛管理提出指导意见。适用于伦理审查中对于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受试者疼痛管理的关注。对临床试验中受试者疼痛予以更多关注,是保护受试者权益的措施之一,有助于保障临床试验顺利开展。Mainly discusses the drafting background,basis and the applicable scope of Ethical considerations for subject pain management in clinical trials,as well as the main source of pain in clinical trials,the general ethical considerations for subject pain management in clinical trials and ethical considerations for subjects pain caused by some test operation procedures in clinical trials,in order to provide guidance for the pain management of subjects in clinical trials from an ethical perspective.It is applicable to the ethical consideration of subject pain management in the ethical review,as well as the attention of researchers to subject pain management in the development of clinical trial protocol and trial procedure.Paying more attention to subjects’pain in clinical trials is one of the measures to protect subjects’rights and interests,which helps to ensure the smooth development of clinical trials.

关 键 词：临床试验 受试者 疼痛 风险 负担 伦理 

分 类 号：R926[医药卫生—药学]