Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership.
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.
Johnson & Johnson Pharmaceutical Research and Development, Titusville, New Jersey 08560, USA. PStang@its.jnj.com
Paul E
PE
Stang
Patrick B
PB
Ryan
Judith A
JA
Racoosin
J Marc
JM
Overhage
Abraham G
AG
Hartzema
Christian
C
Reich
Emily
E
Welebob
Thomas
T
Scarnecchia
Janet
J
Woodcock
D016208:Databases, Factual; D004345:Drug Industry / Q000458:organization & administration*; D006801:Humans; D008490:Medical Informatics / Q000458:organization & administration; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D055818:Public-Private Sector Partnerships / Q000458:organization & administration*; D012984:Software; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D014495:Universities / Q000458:organization & administration*