摘要
儿童用药缺乏相应的临床研究数据支持,开展以儿童为目标人群的药物临床试验迫在眉睫,亟须建立针对儿童群体药物临床试验的法规政策、激励机制,建立和完善儿童临床试验的监管体系,加强信息的公开和监管的透明度,加强儿童临床试验的伦理学审查,完善知情同意流程和建立科学合理的补偿机制,并建立高效的信息交流和共享平台,以便更好掌握儿童药物治疗的现况与需求,以制订相应的引导性政策。
In clinic, it is lack of the pediatric clinical research data for the medicine administration of children. It is necessary and urgent to carry out the pediatric clinical trials of new drugs. It is suggested to establish the appropriate regulations and policies, to establish and improve the supervision and administration system, to strengthen information disclosure and transparency of regulation, and the ethical review of clinical trials, to improve the informed consent process and to establish a scientific and reasonable compensation mechanism. The establishment of an efficient information exchange and sharing platform could better understand current status of and treatment needs of medicine administration of children and useful for developing appropriate policy guidance.
出处
《中国医学伦理学》
2014年第1期88-91,共4页
Chinese Medical Ethics
基金
中国博士后科学基金面上资助(2013M541929)
