The Observational Medical Outcomes Partnership: Improving Post-Market Drug Safety

BETHESDA, Md., Dec. 7, 2010 /PRNewswire/ -- The Foundation for the National Institutes of Health (FNIH) announced the release of the publication "Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership" in the Annals of Internal Medicine. Ann Intern Med November 2, 2010 153:600-606.

The Observational Medical Outcomes Partnership (OMOP) is a public-private partnership composed of representatives from the FDA, academia, 17 corporate and nonprofit organizations in the pharmaceutical industry and health care providers with large health claim or electronic health record databases. The partnership is focused on the need to advance the science of active medical product safety surveillance by using existing health databases.

OMOP's transparent, open innovation approach is designed to provide evidence that can inform a viable national program of active drug safety surveillance. OMOP's research program consists of systematic and empiric investigations of numerous methods and types of observational databases that could become the infrastructure of active surveillance. This article describes the governance structure, data-access model, methods-testing approach, and technology development. The program of study is well under way.

"FDA is very enthusiastic about the Observational Medical Outcomes Partnership," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research and chairwoman of the partnership's executive board. "The partnership presents a substantial opportunity to help develop the tools and expertise needed to improve medical product safety and have a positive impact on health."

In addition to sponsoring specific research efforts, OMOP has created tools that have been placed in the public domain to enable parallel research into drug safety by a broader community of scientific investigators. This includes: experimental protocols, a common data model, database evaluation software, and analytical methods software. Based on the public health mission of the Partnership, all findings from the research project will be made public, including comprehensive reports on the scientific and technical findings, lessons learned, peer-reviewed articles on specific experimental findings by sponsored investigators.

The Observational Medical Outcomes Partnership is funded through, and managed by the Foundation for the National Institutes of Health. "As drug safety concerns increase and budgets tighten, it's more important than ever that the public and private sectors work together to identify drug safety issues in the market environment and mitigate public health risks," concludes Janet Woodcock.

About the Foundation for NIH

Established by the United States Congress to support the mission of the NIH-improving health through scientific discovery in the search for cures-the Foundation for NIH is a leader in identifying and addressing complex scientific and health issues. The foundation is a non-profit, 501(c)(3) charitable organization that raises private-sector funds for a broad portfolio of unique programs that complement and enhance NIH priorities and activities. For additional information about the Foundation for NIH, please visit www.fnih.org.

SOURCE FNIH