Q: What is the Observational Medical Outcomes Partnership?
A: The Observational Medical Outcomes Partnership (OMOP) is a public-private partnership aimed at improving the monitoring of drugs for safety, as well as evaluating benefits.

Q: How is the Partnership funded?
A: OMOP is funded by the Foundation for the National Institutes of Health, with contributions from 17 corporate and non-profit donors. For a full listing of current donors, click here.

Q: What will the Partnership do?
A: The partnership will conduct research to determine the feasibility and value of using healthcare databases to study the effects of medicines on the market. The series of studies will include assessing different types of data from across the United States, developing tools and methods to analyze the databases, and evaluating how analyses can contribute to decision-making. Together, these studies should provide the objective evidence needed to inform best practices for using such data.

Q: Where will the research data come from?
A: Data for the project will come from commonly available commercial health research databases, healthcare providers’ patient records, and insurers’ claims records. OMOP will ensure strict privacy and security safeguards while conducting research on these data.

Q: How will patient data privacy be assured?
A: OMOP will ensure strict privacy and security safeguards while conducting research. Organizations providing data to OMOP will de-identify all patient records and ensure HIPAA compliance. Research using patient-identifiable information will be conducted only by partner institutions within their secure computing facilities. In addition, patient advocates and data privacy experts from the OMOP Executive Board, Scientific Advisory Board, and Health Informatics Advisory Board will provide oversight of the research.

Q: What does the Partnership mean for patients?
A: Enhancing the ability to better identify and evaluate the safety and benefits of medicines has clear benefit for the entire healthcare system, including patients. The partnership hopes that its research will benefit patients in the long term by helping improve the nation’s drug safety system.

Q: Who is involved in the Partnership?
A: The Partnership is a collaborative public-private partnership involving the pharmaceutical industry, academic institutions, non-profit organizations, the Food and Drug Administration, and other federal agencies. It is funded through, and managed by, the Foundation for the National Institutes of Health.

Q: Will findings be released to the public?
A: OMOP intends to promote transparency by placing all information of interest in the public domain as quickly as possible. A publicly accessible web site will communicate the research and maintain awareness for consumers, patients, and providers.

Q: Is the Partnership studying only drug safety?
A: The partnership will utilize methodological research to identify and evaluate all effects of medicines. The primary focus is on potential safety issues, but studies will be conducted to explore beneficial outcomes as well.

Q: Are there unique challenges to studying benefits? Isn't there evidence that observational data aren't useful in understanding benefits?
A: It is true that current observational methods are unsatisfactory for studying health benefits of therapy. But this project will create a new research infrastructure that may prove useful in exploring questions beyond safety. The collaborators therefore will ask a few initial questions to determine how and whether methods can be developed to appropriately study benefit using these kinds of data.

Q: Does the research include medical devices?
A: The partnership core will focus on drugs only. However, an observer from the medical device industry will sit on the Executive Board to ensure its activities can translate to the medical device world.

Q: When will the Partnership complete its research?
A: The current plan calls for the partnership to complete its work by the end of 2010.

Q: How is the Partnership being managed?
A: An Executive Director provides overall executive management under direction from the partnership’s Executive Board and the Foundation for NIH Board. Three Principal Investigators, one each from the pharmaceutical industry, the non-profit sector, and the FDA are leading the research program.

Q: How is the Partnership governed?
A: An Executive Board consisting of consumer, patient, academic, healthcare provider, data provider, FDA, and pharmaceutical industry representatives sets the direction and provides oversight for the partnership. It will be assisted by a Scientific Advisory Board and a Healthcare Informatics Advisory Board, which will provide additional expertise and perspective on key scientific and information technology issues.

Q: Where can I learn more about the Partnership?
A: Visit the partnership’s website at omop.fnih.org for more information.