Details

Autor(en) / Beteiligte

• Stang, Paul E
• Ryan, Patrick B
• Racoosin, Judith A
• Overhage, J Marc
• Hartzema, Abraham G
• Reich, Christian
• Welebob, Emily
• Scarnecchia, Thomas
• Woodcock, Janet

Titel

Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership

Ist Teil von

• Annals of internal medicine, 2010-11, Vol.153 (9), p.600

Ort / Verlag

United States

Erscheinungsjahr

2010

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.