Council of Councils Meeting
July 1, 2010
NIH-HMO Research Network (HMORN) Collaboratory: Common Fund Proposal for NIH Council of Councils
IC LEADERS: ROBERT CROYLE AND MARTIN BROWN (NCI), MIKE LAUER AND BARBARA WELLS (NHLBI)
Purpose: The NIH-HMORN Collaboratory will enhance and strengthen a research platform to accelerate large epidemiology studies, pragmatic clinical trials, and Electronic Health Records (EHR) enabled health care delivery research by leveraging the HMORN's scientific, data and operational infrastructure. Over 16 years, the HMORN and its 15 U.S. members have emerged as a major resource for clinical and population based research, leveraging its large patient population (>13 million members), geographic diversity, and more than 350 multi-disciplinary scientists. HMORN research organizations have received competitive funding for specific research projects and limited infrastructure support from NIH, NCI, NHLBI, NIMH, and NCRR, and from AHRQ, CDC and FDA. However, these efforts do not provide the sustained and ongoing investment necessary to build the scientific capital and harmonize the resources of the HMORN in cutting-edge research priorities over the long run.
Programmatic Goals: The NIH-HMORN Collaboratory will enable a range of transformative research studies that scale up the HMORN's unique capabilities and facilitate the accessibility of HMORN research resources for NIH. The Collaboratory will develop more efficient large scale epidemiological studies to increase our understanding of common and rare human diseases. It will enable informative linkages that leverage high throughput technologies, biobanks, EHRs and other standardized registry activities. It will facilitate efficient design, implementation, and completion of practical trials and enable comparative effectiveness studies of treatments and innovative systems implementation strategies. It will lay the foundation for a national network of delivery systems by expanding to other health systems with integrated health data capabilities.
Federal Governance: The concept of establishing a Collaboratory arose from NIH symposia in 2009 and 2010 involving stakeholders across NIH, AHRQ, CMS, the HMORN and the HMORN-affiliated delivery systems. NIH will establish a broadly representative governance structure that includes trans-Agency and trans-NIH coordinating committees to identify cross-cutting priorities, coordinate activities across all ICs and the affiliated agencies, and to guide scientific direction.
NIH Funding Mechanism: NIH proposes to release a Limited Competition FOA to establish an HMORN Collaboratory Coordinating Center. It will be funded in FY11 as a Cooperative Agreement grant program because there is a need for substantial NIH scientific involvement and guidance. In addition, we propose to release an open competition FOA each year from FY12–15. This trans-NIH FOA will fund studies that test the capability of the HMORN infrastructure. It will enable multiple ICs to be competitive and receive funding, and will focus on new scientific domains. The trans-NIH governance group will develop the funding plan.
Components of the Coordinating Center Cooperative Agreement: The objectives of the HMORN Collaboratory Coordinating Center are to develop and maintain a unified governance structure, build scientific capacity, develop and deploy a Virtual Data Warehouse (VDW), conduct annual scientific meetings, and support developmental studies and expansion activities.
Unified Governance within the HMORN: The HMORN governance structure will serve as the first-line liaison for study development and implementation. It will interface with the trans-Agency and trans-NIH governance structures, and the HMORN Board of Governors and collaboration teams at each HMO research site. The HMORN will be required to establish a Stakeholder Council to include representatives from each partner medical group/health plan. The Stakeholder Council will help prioritize research questions critical to care delivery and financing. The unified governance structure will establish a scalable organizational model to efficiently promote communication, research opportunities, collaborations and study-specific implementation needs; facilitate the development/improvement of shared resources; and ensure ongoing accountability.
Scientific Capacity Building: The overarching objectives for scaling up scientific capacity within the HMORN are to build sustainable collaborative ties with NIH and academically-based (i.e., non-HMORN) scientists to extend the range and volume of studies; cultivate integrative relationships with clinicians and delivery system staff who can contribute to research studies as well as the planning and development of enterprise-wide resources (e.g., biobanks and clinical trials infrastructure); and, recruit and train junior faculty. These teams would focus on NIH ICs not currently involved with the HMORN to scale up in areas where there is opportunity, but limited capacity. Dissemination teams will hasten adoption of evidence-based practices.
Virtual Data Warehouse Development and Deployment: The HMORN VDW is the foundation of the current multi-site research data model. The objectives of this initiative are to improve data quality; enable cross-site and cross project synergies; balance site-, project-, and network-level priorities; and reduce the preparatory work needed to assemble cohorts, count events, and capture exposure and comorbidity data, all in support of an array of different types of studies.
Annual Scientific Conferences: Annual scientific conferences would provide users with educational and technical sessions to inform potential research sponsors and collaborators, including non-HMORN groups, of the nature of the HMORN research resource and the process of collaboration.
Pilot/Developmental Studies and Expansion Activities: Pilot and developmental studies include standardizing and harmonizing new data elements, data abstraction, and survey and trial recruitment instruments, as well as testing informatics tools and in providing proof-of-principle and preliminary data for subsequent full-scale studies funded through competitive mechanisms. Another important objective is to begin expansion of the Network membership to non-HMOs.
Metrics to Evaluate Success: Evaluation metrics examples include the ability to: standardize data across delivery sites; further develop and maintain a high-functioning VDW; bolster the research workforce in partnership with NIH and academic institutions; establish a single “front-door” for collaboration; complete large-scale, retrospective epidemiologic studies; establish and execute a portfolio of pragmatic clinical trials that inform practice; address more diverse topics of interest to the ICs; and rapidly use the intelligence to address questions of emerging national interest.