我国药物临床试验机构发展的现状与问题探讨

Research on the problems and current situation of drug clinical trial institutions in China

经过30多年的发展,我国在药物临床试验机构资格认定、机构建设和监督管理方面有了长足的进步,也推动了我国药物临床试验的快速发展和整体水平的提高。药物临床试验机构在临床试验的规范过程中发挥了重要的作用。本文主要对机构在药物临床试验水平的提高过程中起到的积极作用及其在管理和发展过程中存在的问题做一分析。

After 30 years of development, in our country, we have made great progress in the qualification of drug clinical trial institution, clinical trial institution construction, supervision and management ability, promoting the rapid development of China＇ s drug clinical trials and the overall level of improvement. Drug clinical trials institutions have played an important role in the process of clinical trials. In this paper, we analyzed and discussed the positive effects and the existing problems in the process of management and development of drug clinical trial institutions.