临床试验新型设计方案下治疗性误解的演变及伦理学思考  

Evolution and ethical considerations of therapeutic misunderstandings under the new design scheme of clinical trials

作　　者：张卫中 ZHANG Weizhong(Ethics Committee,Wuyunshan Hospital of Hangzhou/Hangzhou Institute of Health Promotion,Hangzhou 310008,China)

机构地区：[1]杭州市五云山医院/杭州市健康促进研究院伦理委员会,浙江杭州310008

出　　处：《中国医学伦理学》2024年第8期885-889,共5页Chinese Medical Ethics

摘　　要：通过研究参与者的自愿参加,严格设计的临床试验产生了新的可普遍化的科学知识,让更多的未来人群获益,但参加临床试验的研究参与者往往无法区别试验和临床治疗,并期待临床试验能够治疗自身疾病,此种现象称为治疗性误解,因不能满足研究伦理的要求需要加以防止。随着精准医学的到来,临床试验的场景发生了明显的变化,表现为试验和临床治疗互相融合、研究参与者的临床获益变得突出。以治疗为导向的新型设计方案使试验和治疗的界限变得模糊,参加临床试验的研究参与者获得了更多的临床治疗机会,同时也增加了治疗性误解的风险,治疗性误解的内涵发生了变化,引发了更多的伦理学思考。伦理委员会应当更加关心临床试验设计方案的审查、患者参与试验的机会和受试者入组、研究者与研究参与者沟通和知情同意的变化,以及临床医生和研究者的角色界定等方面的内容,保证临床试验在产生新知识的同时,更好地保护受试者的权利、安全和福祉。Through the voluntary participation of subjects,strictly designed clinical trials have generated new generalizable scientific knowledge to benefit more future populations.However,subjects participating in clinical trials often cannot distinguish between trials and clinical treatments,and they expect clinical trials to be able to treat their diseases.This phenomenon is called therapeutic misunderstanding,which needs to be prevented because it cannot meet the requirements of research ethics.With the advent of precision medicine,the scenario of clinical trials has changed significantly,manifested as the integration of trials and clinical treatments,and the prominent clinical benefits of subjects.The new treatment-oriented design scheme blurs the boundary between trial and treatment,giving subjects participating in clinical trials more opportunities for clinical treatment while increasing the risk of therapeutic misunderstanding,changing the connotation of therapeutic misunderstanding,and triggering more ethical thinking.Ethics committees should pay more attention to content related to the review of the design scheme of clinical trials,the opportunities for patients to participate in trials and enrollment of subjects,changes in communication and informed consent between researchers and subjects,the definition of roles for clinicians and researchers,and other aspects,to ensure that clinical trials better protect the rights,safety,and well-being of subjects while generating new knowledge.

关 键 词：治疗性误解 临床试验 临床治疗 设计方案 知情同意 

分 类 号：R-052[医药卫生]