[关键词]
[摘要]
随着我国创新药物研发能力的不断提高,新药临床试验的数量也在不断增加。新药临床试验是验证药品有效性和安全性的关键环节,其结果的可靠性直接关系到百姓的用药安全。临床试验的完成质量受多方因素的影响,其中临床试验机构的管理起重要的作用。通过分析药物临床试验各环节的质量风险因素,并探讨了降低风险的应对措施,以期为药物临床试验的质量管理以及项目质量的提升提供借鉴。
[Key word]
[Abstract]
With the continuous improvement of the development capacity of innovative drugs in China, the number of new drug clinical trials is also increasing. New drug clinical trial is the key link in the verification for efficiency and safety of drugs. Also, the result of drug clinical trials is directly related to the safety of medicines. The completion quality of clinical trials is affected by many factors, in which the quality management of drug clinical trials institution plays an important role. In this article, through analyzing the quality risk in each link of drug clinical trials, we hope to provide reference for quality management and the improvement of the project quality.
[中图分类号]
[基金项目]