摘要：本文对我国中药新药研发临床评价相关问题进行了梳理和分析，如临床研究阶段的分期和动态性、疗效评价指标、上市后再评价等，认为中药新药研发必须重视临床疗效，科学合理进行临床评价。本文为中药新药研发提供了借鉴。

    关键词：中药；新药研发；临床评价

    DOI：10.3969/j.issn.1005-5304.2016.06.004

    中图分类号：R2-05 文献标识码：A 文章编号：1005-5304(2016)06-0014-02

    Abstract： This article summarized and analyzed problems about clinical evaluation of new traditional Chinese medicine， including the staging and dynamics in clinical research stage， indexes of therapeutic evaluation， and post-marketing revaluation. It also proposed that the research and development of new traditional Chinese medicine should attach importance to clinical efficacy and conduct clinical evaluation reasonably. The article provides references for research and development of new traditional Chinese medicine.

    Key words： traditional Chinese medicine； research and development of new medicine； clinical evaluation

    在科技进步和学科发展带动下 ......