Q: What is the Observational Medical Outcomes Partnership?
A: The Observational Medical Outcomes Partnership is a public-private initiative aimed at improving the science of detecting and evaluating drug safety outcomes, as well as benefits. The partnership will launch and direct a two-year research project studying the value of analyzing large observational healthcare datasets for this purpose, chiefly healthcare claims and electronic medical records.

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, as well as the FDA and other federal agencies. It is funded through, and managed by, the Foundation for the National Institutes of Health.

Q: Who is managing the partnership?
A: FNIH has retained an executive director, who is providing overall executive management under direction from the partnership’s Executive Board and the FNIH Board. Three Principal Investigators (PIs) from the pharmaceutical industry, the non-profit sector, and the FDA are leading the research team.

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: 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 a series of research activities to test the feasibility and value of using observational healthcare data to identify and evaluate the effects of medicines. These activities 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 observational data.

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

The research protocols, data models, database evaluation and quality assurance tools, analytical programs and findings generated by the partnership will be published or made publicly available as early as is feasible, enabling other researchers who are not part of or funded by the Research Core to have the opportunity to run specific partnership protocols or variants on their own databases, develop parallel or complementary tools and approaches, and publish their results.

The Partnership will encourage sharing of results and tools developed in this way for the public benefit as a matter of course; external institutions whose aims are in alignment with the partnership’s, who can credibly and objectively perform relevant research, and who are willing to share tools, approaches, findings, and other intellectual property developed as a result may be additionally recognized as members of the Partnership’s Extended Consortium.

Q: How is the Partnership related to the Sentinel Initiative?
A: The Partnership expects that its research will offer useful insights to other efforts aimed at improving the nation’s drug safety—including the Sentinel Initiative, a post-market surveillance project launched by FDA in May 2008—but they are separate programs.

Q: How will data privacy be insured?
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 observational data sources is the partnership using in its research?
A: The Partnership is focused on the use of administrative claims data and electronic health records. The Partnership’s Principal Investigators (PIs) are conducting a data selection process to determine the specific organizations with which to align as part of the partnership’s Research Core. Other data providers will be encouraged to participate as members of the partnership’s Extended Consortium.

Q: What is the Partnership’s Research Core?
A: The Research Core will design, develop, and directly manage the execution of a set of research experiments against the core data sources, and broadly share findings and publish results as specified in the Partnership Publication Policy. All research materials from the Research Core will be made available to the public through open website and peer-reviewed publications. The activities of the Research Core will be managed by the PIs, with the support of the partnership’s executive director and staff, and under review and oversight of the partnership advisory boards.

Q: Who will participate in the Partnership’s Research Core?
A: The Partnership’s Research Core will consist of respected research institutions in the field of epidemiology, including academic, government, and for-profit entities. The partnership will also encourage the participation of the broader scientific community via its Extended Consortium.

Q: What is the purpose of the Partnership’s Extended Consortium?
A: The Partnership’s Extended Consortium is intended to enable parallel research into drug safety by a broad community of scientific investigators.

Q: Who can participate in the partnership’s Extended Consortium?
A: Researchers who are not part of, or funded by, the Research Core and whose aims are in alignment with the Partnership’s, who can credibly and objectively perform relevant research, and who are willing to share tools, approaches, findings and other intellectual property developed as a result may be recognized as members of a Partnership’s Extended Research Consortium.

Q: What are the benefits of becoming a consortium member?
A: Consortium members may benefit from participation in joint publications, cross-citations, and invitations to an annual Research Symposium, sponsored by the Partnership.

Q: I’m a data provider, how can my organization get involved?
A: Data providers that are interested in getting involved should complete the Data Screening Questionnaire on the partnership’s web site. Organizations that complete the survey will be considered for inclusion into the Research Core or Extended Research Consortium.

Q: I’m a researcher, how can I get involved?
A: Under paid contracts or specific collaboration agreements with the Partnership, research institutions will be chosen to execute specific pieces of the research protocols (experiments, analyses) via an open, competitive application and award process managed by the PIs and the partnership executive director in compliance with the Partnership Grants and Contracts policy. Other researchers will be encouraged to participate as part of the Partnership’s Extended Consortium.

Q: Does the research include medical devices?
A: The Partnership Research 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: 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: Is the partnership studying only drug safety?
A: The Partnership will utilize methodological research to identify and evaluate various 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 in studying benefits? Isn't there evidence that these types of 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: Is the Partnership using a centralized data model or a distributed data model?
A: Both. The Partnership expects to collaborate with various data providers, some of which will provide de-identified datasets into a centralized IT research environment, and some of which will conduct the research from within their own firewalls as distributed partners.

Q: Where can I learn more about the Partnership?
A: Visit our website at omop.fnih.org for more information and details on how to contact our staff.