FNIH publishes article aimed to improve medical product safety

FNIH publishes article aimed to improve medical product safety

December 27, 2010

FNIH has released 'Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership' in the Annals of Internal Medicine.

The Foundation for the National Institutes of Health (FNIH) has released “Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership” in the Annals of Internal Medicine (Ann Intern Med. 2010;153:600–606.).

The Observational Medical Outcomes Partnership (OMOP) is a public-private partnership composed of officials from FDA, academia, corporate and nonprofit organizations in the pharmaceutical industry, and healthcare providers with large health claim or electronic health record databases. 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, said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research and chairwoman of the partnership’s executive board.

OMOP’s transparent, open-innovation approach is designed to provide evidence that can inform a viable national program of active drug safety surveillance. Its research program consists of systematic and empiric investigations of numerous methods and types of observational databases that could become the infrastructure of active surveillance.

The article describes the governance structure, data-access model, methods-testing approach, and technology development. The program of study is under way.

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, and peer-reviewed articles on specific experimental findings sponsored by investigators.