Johnson & Johnson Pharmaceutical Research and Development, Titusville, New Jersey 08560, USA.
Ann Intern Med. 2010 Nov 2;153(9):600-6. doi: 10.7326/0003-4819-153-9-201011020-00010.
The U.S. Food and Drug Administration (FDA) Amendments Act of 2007 mandated that the FDA develop a system for using automated health care data to identify risks of marketed drugs and other medical products. The Observational Medical Outcomes Partnership is a public-private partnership among the FDA, academia, data owners, and the pharmaceutical industry that is responding to the need to advance the science of active medical product safety surveillance by using existing observational databases. The Observational Medical Outcomes Partnership's transparent, open innovation approach is designed to systematically and empirically study critical governance, data resource, and methodological issues and their interrelationships in establishing a viable national program of active drug safety surveillance by using observational data. This article describes the governance structure, data-access model, methods-testing approach, and technology development of this effort, as well as the work that has been initiated.
2007 年美国食品和药物管理局（FDA）修正案要求 FDA 开发一个系统，以利用自动化医疗保健数据来识别已上市药物和其他医疗产品的风险。观察性医疗结局伙伴关系是 FDA、学术界、数据所有者和制药行业之间的公私合作伙伴关系，旨在通过使用现有的观察性数据库，推进积极的药物安全监测科学。观察性医疗结局伙伴关系的透明、开放创新方法旨在系统地和经验性地研究关键的治理、数据资源和方法学问题及其相互关系，以建立一个可行的国家主动药物安全监测计划，使用观察性数据。本文描述了这一努力的治理结构、数据访问模型、方法测试方法和技术开发，以及已经启动的工作。
