药物临床试验中纳入弱势对象作为受试者相关问题的思考及审评实践

Cogitation and evaluation practice on enrolling vulnerable subjects in drug clinical trials

审评实践中发现仍有研究者对药物临床研究过程中纳入弱势对象作为受试者问题不够关注。综述国内外相关法规、指导原则对于药物临床试验纳入弱势对象作为受试者相关规定。我国现行版《药物临床试验质量管理规范》(2003版)对此未做出明确要求。2013年修订版《世界医学大会赫尔辛基宣言》明确指出,弱势对象参与研究的两个限制条件为弱势群体参与的研究是在非弱势群体不能开展的研究,参与研究弱势群体应当切实受益。人用药品注册技术要求国际协调会(ICH)E6在"ICH GCP原则"章节中明确规定临床试验的实施应符合赫尔辛基宣言的伦理原则。故自2017-06-01国家食品药品监督管理总局加入ICH起,我国药物临床试验的施行应同时符合我国《药物临床试验质量管理规范》、ICH E6及《赫尔辛基宣言》的要求。药品审评中心也应严格按照上述法规及指导原则的规定,在审评实践中无条件执行上述相关规定,对于弱势对象参与药物临床试验进一步加强监管。

Enrolling vulnerable subjects in drug clinical trials was discovered in the evaluation practice. We review the related laws,regulations and guidelines. There is not definite requirement about vulnerable subjects in the good clinical practice（ GCP） in our country（ 2003 edition）.The precondition for enrolling vulnerable subjects in clinical trials was that the research cannot be carried out in non-vulnerable group and this group stand to benefit from the result form the research in World Medical Association（ WMA） Declaration of Helsinki（ 2013 edition）. And International Conference on Harmonization of Requirements for Registration Pharmaceuticals for Human Use（ ICH） E6 clearly required that any clinical trial should keep to the ethical principles in WMA Declaration of Helsinki. So the clinical trials carried out in our country should obey the requirement of WMA Declaration of Helsinki,GCP of ICH and our country meanwhile since June 1^（st）,2017,when China Food and Drug Administration（ CFDA） was a member of ICH. Center for drug evaluation（ CDE）also should execute the laws,regulations and guidelines above-mentioned in evaluation practice. And enrolling vulnerable subjects in clinical trials should be in strengthened supervision.