构建中医肝病新药临床试验研究技术平台探索

摘要

通过中医肝病临床新药伦理委员会、实验方法学、疗效评价、数据管理等技术平台的建设，及相关技术平台的建设，构建符合中医肝病疗效特点的新药临床评价方法和指标体系，从而搭建符合国际GCP规范的中医肝病新药临床试验技术平台。%This study was aimed to construct a clinical trial technological platform of traditional Chinese medicine (TCM) live disease in accordance with the international good clinical practice (GCP) standard. Through the con-struction of technological platforms such as clinical new medicine ethics committee of liver disease of TCM, ex-perimental methods, curative effect evaluation, data management, and etc., the clinical evaluation method and in-dex system of new drugs with the curative effect characteristics of liver disease of TCM were established. It was concluded that under the construction of relevant technological platform, an effect evaluation method and index system with TCM diagnosis and treatment characteristics were built . And a key clinical trial technological platform of new drugs of TCM liver disease was established to meet requirements of the international GCP standard.