摘要
药物临床试验是现代医学发展的重要支柱,是药物研发的必经环节,其迅猛发展的同时也带来了诸多问题,如受试者(特别是与其他适应证受试者相比具有特殊性的精神类受试者)的合法权益受到侵害的事时有发生,如何保护为医学进步做出重大贡献的受试者的权益越来越受到社会各界的普遍关注和思考。本文将基于医学视角,结合精神类受试者及精神类药物的特殊性,从药物临床试验开始前、试验过程中及试验结束后3个方面简单阐述如何保护精神类受试者的权益,并从知情同意过程、精神患者特殊处理、对照药物及试验结束时后续治疗药物的选择等方面提出可行性建议,以期完善精神类受试者权益保护工作。
Drug clinical trial is the important pillar of modern medicine,which also is the key step in drug development. Its dramatic development also brings problems,such as often harms the legitimate rights and interests of subjects especially in particular psychiatric patients. The problems how to protect the rights and interests of subjects are getting more and more attention in the society. Based on the medical point of view,we should consider specific subjects,and explain how to protect the subjects＇ rights from the beginning to the end of the clinical trials.We will propose some feasible suggestions for the process of informed consent,particular psychiatric patients＇ treatment,and the choice of subsequent medicine after the trial ending. We hope our paper can improve the rights protection in psychiatric subjects.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第18期2078-2081,共4页
Chinese Journal of New Drugs
关键词
药物临床试验
精神类受试者
权益保护
clinical trials for drugs
subjects with mental disease
rights and interests protection
