作為“臨床試驗(yàn)中對(duì)受試者疼痛管理的倫理考慮”系列標(biāo)準(zhǔn)之一，主要論述《兒科人群臨床試驗(yàn)中對(duì)受試者疼痛管理的倫理考慮》的起草背景、制定依據(jù)和適用范圍，以及兒科人群臨床試驗(yàn)中受試者疼痛等負(fù)擔(dān)的來源和識(shí)別、在兒科人群臨床試驗(yàn)方案設(shè)計(jì)和臨床試驗(yàn)執(zhí)行過程時(shí)使受試者疼痛最小化的措施，以期從倫理角度對(duì)兒科人群臨床試驗(yàn)中受試者疼痛管理提出指導(dǎo)意見。其適用于倫理審查中對(duì)于兒科人群臨床試驗(yàn)中受試者疼痛管理的倫理考慮，以及研究者制定臨床試驗(yàn)方案和試驗(yàn)流程對(duì)兒科人群疼痛管理的關(guān)注。對(duì)臨床試驗(yàn)中兒科人群疼痛予以更多關(guān)注，是保護(hù)兒科受試者權(quán)益的措施之一，有助于保障兒科臨床試驗(yàn)順利開展。

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.

R926

國家“十三五”重大新藥創(chuàng)制專項(xiàng)課題（2019ZX09734001）；北京醫(yī)學(xué)倫理學(xué)會(huì)科研課題（BMEA2021105）