Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership
Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership
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DOI：
10.7326/0003-4819-153-9-201011020-00010
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发表时间：
2010-11-02
影响因子：
39.2
通讯作者：
Woodcock, Janet
中科院分区：
文献类型：
--
作者：
Stang, Paul E.;Ryan, Patrick B.;Woodcock, Janet
2007年的美国食品和药物管理局(FDA)修正案要求FDA开发一个系统，使用自动医疗数据来识别上市药物和其他医疗产品的风险。观察性医疗结果伙伴关系是FDA、学术界、数据所有者和制药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来推动积极的医疗产品安全监测科学的发展。观察性医疗结果伙伴关系的透明、开放的创新方法旨在系统和实证地研究关键的治理、数据资源和方法问题以及它们之间的相互关系，以便利用观察数据建立一个可行的国家主动药物安全监测计划。本文描述了这项工作的治理结构、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。
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.