本文介绍了中药新药临床研究分期,并从受试病例的选择(包括诊断标准、纳入标准及排除标准)、对照药物的选择、病例分组及对照方法、观测指标的确定、不良反应观测及分析、疗程及观测时点的合理性、疗效判定标准、临床研究总结报告等方面阐述中药新药临床研究的基本要求和存在的问题。 This article introduces the staging of new drug clinical research, and from the choice of test cases (including diagnostic criteria, inclusion criteria and exclusion criteria), control drug selection, case grouping and control methods, the determination of observation indicators, observation and analysis of adverse reactions, Course of treatment and the rationality of the point of observation, criteria for the determination of efficacy, clinical research summary report, and other aspects of the basic requirements of traditional Chinese medicine clinical research and existing problems.