[关键词]
[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。
[Key word]
[Abstract]
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.
[中图分类号]
R926
[基金项目]
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)