中国药物临床试验的质量管理

摘要

The article introduced the current status of clinical trials and quality issues in China, as well as international Good Clinical Practice and concepts such as the efficient setup of quality management system, and quality-by design. Key components of quality and process in clinical trial and all the clinical trial stakeholders, as well as quality assurance and control approaches adopted by in China, have been discussed later. In summary, to achieve the quality goals of including good scientific design, effectively answering the specific research questions with the reliable data as well as protection the right of the participants, all the stakeholders, multidiscipline talents and professionals should cooperate in the different stages of the clinical trial and explore the practical Chinese quality management model.%本文指出了我国药物临床试验的现状及存在的质量问题,介绍了国际药物临床试验的质量管理规范及理念,如建立有效的以数据为中心的质量管理体系、临床试验质量应该被设计等,并分别从质量要素和临床试验重要流程、中国临床试验各相关参与方承担的职责以及对提高试验质量采取的质量保证和控制措施等方面进行了探讨.为了达到保证试验的科学性、保护受试者权益并获得可信数据来有效地回答科学问题这一系列质量目标,在药物临床试验各个阶段需要所有参与方、多学科、多方面人才的合作.本文旨在探索适合中国现状的质量管理模式.