儿科药品临床试验中的相关问题探讨

由于缺药、超标签用药以及药品不良反应等导致的儿童死亡和疾病屡见不鲜，但这些都是可以通过恰当使用儿科药物而有效避免。我国儿童数量众多，但有儿童临床证据的药品却十分少。儿科临床试验的开展一直是儿科药品研究中的主要阻碍，这其中存在方方面面的问题，其中包括家长对知情同意书的理解、受试儿童的招募、经济补偿、伦理道德以及儿童的依从性等各个方面。本文将围绕这些方面的问题进行分析，借鉴国外学者的研究成果并提出相应建议。

Discussion of problems related to clinical trial of pediatric medicine

The diseases and even death occurred in children are common because of the lack of medicine, off label drug use and adverse drug reactions, which can be effectively avoided through appropriate use of the pediatric medicine. There are a large number of children in China, however, pediatric medicines with clinical evidences are rare. The clinical trial performed in children is one of the main obstacles for the research and development of pediatric medicine, which includes various aspects such as the understanding of parents to the informed consent, recruitment of children volunteers, economic compensation, ethics and the compliance of children. The problems involved will be analyzed in this article and the corresponding suggestions will be proposed based on the research results from foreign scholars.