Construction of Clinical Trial Technological Platform of Traditional Chinese Medicine Live Disease / 世界科学技术-中医药现代化

ABSTRACT

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.