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Research and Reporting Methods |

Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership

Paul E. Stang, PhD; Patrick B. Ryan, MEng; Judith A. Racoosin, MD, MPH; J. Marc Overhage, MD, PhD; Abraham G. Hartzema, PharmD, MSPH, PhD; Christian Reich, MD, PhD; Emily Welebob, RN, MS; Thomas Scarnecchia, MS; and Janet Woodcock, MD
[+] Article, Author, and Disclosure Information

From Johnson & Johnson Pharmaceutical Research and Development, Titusville, New Jersey; Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, Maryland; GlaxoSmithKline, Research Triangle Park, North Carolina; Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland; Regenstrief Institute and Indiana University School of Medicine, Indianapolis, Indiana; College of Pharmacy, University of Florida, Gainesville, Florida; and Digital Aurora, Manchester, Vermont.

Disclaimer: This article expresses the views of the authors and does not necessarily represent those of their affiliated organizations.

Acknowledgment: The OMOP thanks Jeffrey S. Dubin, MD, MBA, for his clinical and editorial input.

Grant Support: The OMOP is funded by the Foundation for the National Institutes of Health, with contributions from a consortium of 17 organizations (Appendix Table). Three members of the research team (Dr. Stang, Mr. Ryan, and Dr. Racoosin) serve in-kind and are not compensated for their participation.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-1147.

Requests for Single Reprints: Paul E. Stang, PhD, Johnson & Johnson, 1125 Trenton-Harbourton Road, PO Box 200, MS K304, Titusville, NJ 08560; e-mail, PStang@its.jnj.com.

Current Author Addresses: Dr. Stang: Johnson & Johnson, 1125 Trenton-Harbourton Road, PO Box 200, MS K304, Titusville, NJ 08560.

Mr. Ryan, Dr. Reich, and Ms. Welebob: Foundation for the National Institutes of Health, 9650 Rockville Pike, Bethesda, MD 20814.

Dr. Racoosin: U.S. Food and Drug Administration, 10903 New Hampshire Avenue, WO51-6346, Silver Spring, MD 20993-0002.

Dr. Overhage: Medical Informatics, Regenstrief Institute, Inc., Health Information and Translational Sciences Building (HITS), 410 West 10th Street, Suite 2000, Indianapolis, IN 46202.

Dr. Hartzema: College of Public Health and Health Professions, University of Florida, HPNP, Room 3339, 101 South Newell Drive, PO Box 100496, Gainesville, FL 32610-0496.

Mr. Scarnecchia: PO Box 686, Manchester, VT 05254.

Dr. Woodcock: U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 6133, Silver Spring, MD 20993.

Author Contributions: Conception and design: P.E. Stang, P.B. Ryan, J.M. Overhage, A.G. Hartzema, C. Reich.

Analysis and interpretation of the data: P.E. Stang, P.B. Ryan, J.A. Racoosin, J.M. Overhage, A.G. Hartzema, C. Reich, E. Welebob.

Drafting of the article: P.E. Stang, P.B. Ryan, J.M. Overhage, E. Welebob, T. Scarnecchia.

Critical revision of the article for important intellectual content: P.E. Stang, P.B. Ryan, J.A. Racoosin, J.M. Overhage, A.G. Hartzema, C. Reich, J. Woodcock.

Final approval of the article: P.E. Stang, P.B. Ryan, J.A. Racoosin, J.M. Overhage, A.G. Hartzema, T. Scarnecchia, J. Woodcock.

Provision of study materials or patients: P.B. Ryan.

Statistical expertise: P.E. Stang, P.B. Ryan.

Obtaining of funding: P.E. Stang, P.B. Ryan, T. Scarnecchia.

Administrative, technical, or logistic support: P.E. Stang, P.B. Ryan, C. Reich, E. Welebob, T. Scarnecchia, J. Woodcock.

Collection and assembly of data: P.E. Stang, P.B. Ryan, J.M. Overhage, C. Reich, E. Welebob.

Ann Intern Med. 2010;153(9):600-606. doi:10.7326/0003-4819-153-9-201011020-00010
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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.





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