我国药物临床试验机构现状分析

Situation analysis for drug clinical trial institutions

药物临床试验是新药研发的一个重要环节,其操作的规范程度直接关系到药物研发的成败。因此,提高新药临床试验的质量至关重要,而药物临床试验机构在药物临床试验质量管理中起到十分关键的作用。在制药行业国际化发展和临床试验产业化大趋势下,我国药物临床试验机构经过多年的发展,药物临床试验的整体水平迅速提高,也开展了大量的中药新药临床试验。但与欧美发达国家相比,我国药物临床试验起步晚,对药物临床试验及药物临床试验管理的认识还有待提高。因此,我国药物临床试验机构的建设和管理依旧任重道远。该研究从机构组织管理、机构地区和专业分布以及药物临床试验机构质量管理3个方面对当前我国药物临床试验机构的发展现状进行分析,并对目前机构管理中存在的问题进行探讨,提出加大中医专业建设、引入药品风险管理和加强信息化管理3方面的建议,以期为今后机构的发展和建设提供一些参考。

Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore,improving the quality of drug clinical trials is of great importance,and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials.After years of development,the overall level of drug clinical trials has advanced rapidly in China,and a large number of clinical trials of traditional Chinese medicine have also been carried out. However,there is still a big gap between our country and developed countries. Therefore,for the construction and management of Chinese drug clinical trial institutions,there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects,including current situations of institutional organization and management,regional and professional distributions,and quality control. And some suggestions are put forward finally,including support of traditional Chinese medicine,introduction of drug-risk management system,and construction of information management.