“三结合”中药审评证据体系下儿童用药临床试验年龄段的选择

中药审评审批机制改革以来,在“三结合”中药审评证据体系下,儿童用药研发积极性日益增高,对于需要开展临床试验者,年龄段的选择是研发者容易忽视的问题。针对来源于人用经验的中药儿童用药研发临床试验中年龄段的选择提出了相关思考和建议,如需关注中医药理论、人用经验情况、目标人群发病情况、剂型选择适宜性、疗效评价指标和工具的适用性,以及对临床试验实施的影响等,以期为中药儿童用药研发提供参考。

Age of pediatric population in clinical trials of traditional Chinese medicine development under "three combined" evaluation evidence system of TCM

Since the reform of the review and approval mechanism of traditional Chinese medicine(TCM) new drugs development, under the "three combined" evaluation evidence system of traditional Chinese medicine, the enthusiasm of children''s drug research and development has been increasing. For those who need to carry out clinical trials, the age of subjects in clinical trials tend to bed ignored. This paper puts forward some thoughts and suggestions on the issues that need to be paid attention to in the clinical trial of children''s medication research and development of traditional Chinese medicine, such as the need to pay attention to TCM theory, human use experience, the incidence of the target population, the suitability of dosage form, the suitability of efficacy evaluation tools, etc. In order to provide reference for the research and development of children''s medicine of TCM.