中国特色药物临床试验机构质量管理体系建设

Construction of quality management system with Chinese characteristic for drug clinical trial institution

药物临床试验是药品上市最后一道评价防线,其研究资料和数据是药品上市的主要依据,其质量直接影响到药品质量和公众用药安全。药物临床试验机构要保障药物临床试验质量,依靠简单的质控无法达到要求,应根据中国医院的管理现状,建立医院和专业两个层级的质量管理体系。质量管理系统是由组织机构和职能、管理文件、培训、质控、体系评估和持续改进组成的管理循环,该体系良好运行才能保证药物临床试验科学、伦理,数据真实、完整、准确、可靠。

Drug clinical trial is the last evaluation stage before marketing,the research materials and data are the principle evidences for the approval of drug.The quality of clinical trial directly affects the quality of medical product and its safety use for public.Inspection storm of clinical trial has exposed that most of sponsors are vacancy in quality management of drug clinical trial,and also exposed that there are many problems in quality control of drug clinical trial institution.Since drug clinical trial institution accreditation in 2004,it paid more attention in clinical quality,the strength of quality control increased constantly,and the quality of clinical trial were also improved with a certain extent,but it still has a large gap to the core of good clinical practice（GCP）.In the author’ s opinion,the quality of clinical trial can not only rely on the pure quality control.According to the current management situation of Chinese hospital,we should establish quality management systems form of hospital and clinical specialties.The quality management system is a cycle system which was incorporated with organization and its functions,management documents,training,quality control,system evaluation and continuous improvement,only when it run well,can the clinical trials be ensured to be scientific and ethical,and the data to be true,complete,accurate and reliable.