Research

OMOP is working with research investigators and organizations to conduct methodological research and make the findings available to the public.

OMOP 2013-2016 Research Agenda
OMOP's direction is defined by the OMOP Strategic Objectives and Tasks 2013-2016. The overall strategy has an emphasis on building upon OMOP's prior research and empirical evidence base while increasing alignment with the needs of the FDA Sentinel Initiative and the community. Please contact OMOP if you have any questions or comments about the objectives and tasks.

OMOP Strategic Objectives and Tasks 2013-2016

  1. Objectives

Through its research, the Observational Medical Outcomes Partnership aims to:

  • Create a foundation for the common representation of disparate healthcare data so they can be subjected to reproducible analysis;
  • Create an empirical evidence base to support study of the association between medical products and outcomes, both known and unknown,
    and
  • Create a framework for incorporation of observational data into evidence based decision making

If this work is successfully completed, appropriately skilled entities:

  • will be able to investigate the association between drugs of interest and the most important adverse outcomes, with an empirically based foundation for interpretation of findings
  • will have an understanding of the utility of observational healthcare data for the identification of unknown outcomes associated with medical products
  • will have a framework for incorporating the results of observational studies into decisions about medical interventions.
  1. 2013-2016 Infrastructure and Operations Tasks
  • Continue the development of the Common Data Model, standardized vocabularies, and data characterization tools that support the use of healthcare system data for the assessment of medical product safety and effectiveness.
  • Function as the catalyst for active engagement of the research, regulatory, and healthcare communities to share in the development, adoption, and implementation of the CDM and standardized vocabularies
  • A long-term goal of this task is for the healthcare system data user community to converge on a single CDM that it adopts and maintains as a data standard
  • Coordinate, conduct and collaborate in research that will enable the implementation of the FDA Sentinel project as a widely accessible, empirically characterized risk identification and analysis system, and the practice of others in the fields of risk and effectiveness identification and analysis (pharma company projects, PCORI, and others)
  • Provide a testbed to generate empirical evidence on the performance of methods and data sources prior to implementation within the FDA Sentinel Project
  • In collaboration with key stakeholders, translate key research findings into standards of practice
  • Actively communicate the OMOP research and results within the scientific, medical and healthcare community
  1. 2013-2016 Research Tasks
  • Expand the empirical evidence to support the study of the effects of medical products in observational data
    1. Extend the evidence base from the 4 health outcomes of interest that were the subject of the 2011-12 OMOP research to the approximately 20 key health outcomes of interest for pharmacovigilance (Ref: Trifiro, G., et al., Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiol Drug Saf, 2009. 18(12): p. 1176-84)
    2. Evaluate the contribution of observational clinical data (eg, electronic health record data), compared to claims data, to the study of medical product effects
    3. Continue the development of novel methods and the improvement of existing methods for observational data analysis
    4. Begin to explore the use of observational data for the identification of benefits
  • Develop a framework for incorporating observational data and stakeholder perspectives into decision making.
  • Develop analytical methods and evidence to enable active surveillance of newly marketed medical products over time, including establishing a framework for evaluating how and when observational data can be used to rule out medical product - outcome associations of concern or interest.
  • Develop empirical evidence to evaluate the performance of methods for detecting unknown associations between medical products and outcomes
  • Download OMOP Strategic Objectives and Tasks 2013-2016