平行对照药物临床试验加单臂开放期延续试验的伦理审查案例分享

Caeses sharing of ethical review in parallel-control drug clinical trials with one-arm extended open trials

本文列举了北京天坛医院医学伦理委员会自2014年至今受理的85项药物临床试验伦理审查中5例平行对照药物临床试验加单臂开放期延续使用试验用药项目的案例,在阐述审查过程中发现的问题和教训的基础上,根据《赫尔辛基宣言》及我国《药物临床试验管理规范》等伦理审查相关文件的伦理审查原则和要求,分析了临床试验的科学性、受试者风险与受益等问题,并对审查的项目提出一些具体意见和建议,为伦理审查过程中进一步完善试验方案设计的科学性及合理性,减少受试者风险,保护受试者权益等方面提供参考。

This study listed 5 cases of parallel-controll drug clinical trials with one-arm extended open trials in 85 ethical reviews accepted by the Medical Ethics Committee of Beijing Tiantan Hospital from 2014 to now.Based on the problems and lessons found in the review process,according to the Helsinki Declaration and the Regulations for the Management of Clinical Drug Trials in China,the principles and requirements of documents related to ethical review are analyzed,including the scientificity of clinical trials,the risks and benefits of subjects.Some specific opinions and suggestions were put forward to provide references for further improveing the scientificity and rationality of the experimental design,reducing the risks of subjects,and protecting the rights and interests of subjects in the process of ethical review.