乳腺增生症中药新药临床研究关键问题

The key issues in clinical research of investigational Chinese medicine in mammary hyperplasia

在药品监管政策较大变动的背景下,中药新药的研发思路正在转变为"以临床价值为导向"、"符合中医药特点的中药安全和疗效评价方法"和"彰显中医药在疾病治疗中的优势"。本文基于以临床价值为导向、体现中医药特点的整体研究理念,从立项可行性分析、临床研究定位、临床试验方案设计的总体考虑和关键问题、试验药物的安全性评估以及质量控制措施6个方面,阐述了乳腺增生症临床研究方案设计中需关注的关键问题。

Under the background of big changes in drug regulatory policies,the ideas on research and development of investigational Chinese medicine are converting into"clinical value-oriented","safety and efficacy evaluation methods in line with the characteristics of TCM"and"highlighting the advantages of TCM in disease treatment".Based on the overall research idea of clinical value orienting and the reflecting of characteristics of TCM,this article mainly discusses the key issues in clinical research of investigational chinese medicine in the treatment of mammary hyperplasia based on six aspects,including feasibility analysis of project approval,positioning of clinical research,overall considerations and key issues of clinical trial protocol design,safety assessment of investigational Chinese medicine,as well as quality control measures.