在我国药物临床试验机构建设中引入国际通行管理模式

摘要

With the movement of global drug research and development centers to the East, Chinese medicine and clinical trial markets have developed rapidly. Clinical trial inslitutions, however, still have got a long way to go. Only by introducing Site Management Organizations (SMO, currently the most internationally recognized management method) , establishing a strong quality management system, maintaining good operation procedures, improving clinical trial management and assuring trial quality will China's clinical trials can meet international standards.%随着全球新药研发重心东移,我国医药市场和临床试验的市场迅速发展,药物临床试验机构建设任重而道远,引入以现场管理组织(SMO)管理模式为代表的国际通行管理模式,建立完善的质量管理体系,保持良好的运作机制,提高试验的综合管理水平,保证临床试验的质量,使国内药物临床试验机构完成的试验数据得到国际认可,将有利于推动中国药物临床试验与国际接轨的进程.