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本课题组在十二五期间,将“药物临床试验项目管理系统”应用于中药新药临床Ⅱ、Ⅲ期项目,为提高临床试验质量提供了保障,为中药新药临床试验规范化、标准化提供了科学可行的研究模式,加强了我院中药新药临床评价技术平台建设。
During the 12th five-year plan period, our group applied “Drug clinical trial project management system” to clinical phase II and III of new drug of traditional Chinese medicine, which provided guarantee for improving the quality of clinical trial and provided standardization and standardization of new drug clinical trial Scientific and feasible research model, strengthen our hospital new drug clinical evaluation technology platform construction.