儿科药品临床研究立项与试验设计策略分析

Strategies of the initiation and design of paediatric drug trials

儿科药品临床研究是完善儿科用药信息的有效途径之一。鉴于目前市场上儿科用药信息普遍缺乏,需要根据临床需求的迫切程度,选择优先关注领域,逐步完善,因此,前期立项依据尤为重要。本文引用国外该领域研究发现及成果,结合相关实例,对儿科临床研究试验设计桥接研究、不同年龄段特殊性、标本的采集与使用、对照组选择、知情同意、评估的终点指标等进行考虑,旨在为同行提供参考。

Clinical research of pediatric drugs is one of the effective ways to improve children＇s medication information. In view of the lack of medication information for children, we should improve it gradually according to clinical demand and the priority areas of concern. Thus the prophase of the project is particularly important. Refer- enced to new founds and achievements in this field of foreign countries and combined some examples, this review focuses on some considerations for the design of pediatric drug trials, such as initiating a project basis, risk and benefit, bridging research, the particularity of different ages, specimen collection and use, the selection of control group, inform and consent, assessment of endpoint, and so on The review maybe offer help for peers.