药物临床试验中的受试者抱怨案例分析与对策探讨

Analysis and discussion on the subject complaint in clinical drug trials

目的通过探讨伦理委员会对受试者抱怨事件的管理,发现并改正临床试验过程中损伤受试者权益的问题,提高伦理委员会保护受试者权益的能力。方法回顾性分析北京大学人民医院伦理委员会2021年1至12月受理的13例临床试验受试者抱怨事件,分析抱怨的原因,提出解决对策与建议。结果受试者抱怨中存在关于补偿费用的发放、研究者沟通态度和技巧以及受试者理解偏差等方面的问题。结论伦理委员会要高度重视受试者抱怨,采取闭环管理流程,进行分级管理,严格伦理审查,提高全过程跟踪监管能力,针对性对研究者开展培训,为受试者提供咨询服务,改善研究者与受试者之间的沟通,有效减少和避免抱怨事件的发生。医疗卫生机构相关职能部门协同合作共同保护受试者的权益。

Objective By exploring the management of subject complaints by the ethics committee,to identify and correct the problems that damage the rights of subjects in clinical drug trials,in order to improve the ability of the ethics committee of protecting the rights and interests of the subjects.Methods We conducted a retrospective analysis of 13 cases of subject complaints accepted by the Ethics Committee of Peking University People′s Hospital from January to December 2021,analyzed the causes of complaints,and proposed countermeasures and suggestions.Results Problems exist in the subject complaints regarding the payment of compensation,investigators′communication attitude and skills,subjects′understanding bias,etc.Conclusions The ethics committee should attach great importance to subject complaints,adopt a closed-loop management process,carry out hierarchical management,strict ethical review,improve the ability of continuous supervision,conduct targeted training for investigators,and provide counseling services for subjects,to improve the communication between investigators and subjects,effectively reduce and avoid the occurrence of complaints.Relevant functional departments of medical and health institutions should work together to protect the rights and interests of the subjects.