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Pages 1-16

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From page 1...
... Definitional boundaries of autoimmunity and autoimmune disease are evolving, and there are differing approaches to characterizing autoimmune diseases -- one based on clinical criteria and another based on underlying biological mechanisms. The diseases are heterogeneous in presentation, 1 References are not included in the report summary.
From page 2...
... Congressional interest in autoimmune diseases, driven largely by constituents, advocacy groups, and other stakeholders, is longstanding, and congressional requests and mandates have contributed to the trajectory of NIH autoimmune disease research. CHARGE TO THE COMMITTEE In response to a congressional request, the National Institutes of Health (NIH)
From page 3...
... • Evaluate Institute and Center structure in support of NIH autoimmune disease research to identify where needs are met and where coordination could be enhanced. • Produce  and  publish  a final consensus committee report summarizing the committee's findings, conclusions, and recommendations.
From page 4...
... To arrive at a final list, the committee considered autoimmune diseases that are identified in congressional language requesting this study; are overrepresented in women; may affect multiple systems and are associated with comorbidities; and that illustrate the spectrum of autoimmune disease. A final consideration was the availability of data on NIH research funding for the disease, as the committee had determined that this could provide valuable information on the focus of NIH's autoimmune disease research portfolio.
From page 5...
... The committee examined overall NIH spending for autoimmune disease research grants and projects and that of 13 ICs that contribute the most funding to autoimmune disease research. The committee examined congressional action regarding NIH autoimmune disease research, the different types of NIH funded grants and awards, the process for reviewing and awarding grants, and the funding and operation of extramural and intramural programs.
From page 6...
... The methodologies are in Appendix G CROSSCUTTING ISSUES IN AUTOIMMUNE DISEASES Based on its review of the literature, the committee highlighted the characteristics that are common across autoimmune diseases because they provide valuable information about disease pathogenesis that could provide direction for more targeted research that might lead to strategies to prevent, delay, diagnose, treat, and cure disease.
From page 7...
... ANALYSIS OF INSTITUTE AND SPECIFIC AUTOIMMUNE DISEASE RESEARCH ACTIVITY In reviewing NIH's research portfolio on autoimmune diseases, the committee employed a general framework that considered the inputs (spending) , activities (research conducted)
From page 8...
... Despite the generation of important information summarizing the autoimmune disease research enterprise, the committee encountered substantial challenges in making quantitative or qualitative judgements about the portfolio and the progress made to address the broad range of autoimmune diseases. In part, this is because a recent overarching strategic research plan with implementation goals and milestones does not exist, thus the committee was unable to discern concrete metrics against which progress could be assessed.
From page 9...
... Major barriers to NIH's ability to maximize outcomes of this research portfolio is the variation found in IC strategic plans regarding autoimmune diseases and most significantly, the absence of a research plan that spans all ICs to provide an overall strategic NIH plan for autoimmune diseases. Absent the latter, NIH lacks a comprehensive, transparent, and strategic approach to how it plans and evaluates progress made on autoimmune disease research.
From page 10...
... However the committee believes that any centralized entity, to be effective, will require new resources; and that the broader and better research enterprise on autoimmune disease has a greater potential to bring relief to patients and their families. The committee considered five options for enhancing autoimmune disease research and resulting outcomes.
From page 11...
... Given this, the committee considered two configurations of this Office. In the first, the Office would have its own research budget and it would substantially control certain key budgetary decisions about autoimmune disease research activities conducted elsewhere in NIH.
From page 12...
... 5. Address autoimmune disease research workforce and training issues, includ ing diversity of the workforce.
From page 13...
... 7. Coordinating autoimmune disease research across other HHS agencies and other federal agencies (e.g., AHRQ, CDC, FDA)
From page 14...
... Acknowledging that creating an of Office of Autoimmune Disease/ Autoimmunity Research may take some time, the committee makes two specific recommendations related to data collection that could be implemented independent of the Office by ICs, one independently and the other in collaboration with other ICs.  First, progress on autoimmune disease requires substantially more sophisticated and refined epidemiology on the individual and aggregate burden of autoimmune disease. The extant knowledge base is growing, but there are important gaps, including trends with respect to incidence and prevalence, comprehensive evaluations of the burden (including direct and indirect costs)
From page 15...
... Achieving this objective will require coordination and collaboration among researchers, research groups, and stakeholders as well as the dedicated pursuit of research that: defines autoantibodies that predict and diagnose autoimmune diseases; identifies common mechanisms in inflammation; determines gene-environment interactions within and across autoimmune diseases; examines the role of environmental exposures on autoimmune diseases; elucidates disparities and their determinants; determines the impact of comorbidities and complications of autoimmune diseases on clinical outcomes, functional outcomes, quality of life and health care utilization; and explores the effect of interventions to mitigate impact of comorbidities and complications for patients with autoimmune disease across the lifespan. PREPUBLICATION COPY -- Uncorrected Proofs
From page 16...
... CONCLUSION The quantity and quality of the research NIH conducts on autoimmune diseases is impressive. The committee believes that a strategic plan for all NIH autoimmune disease research and a well-configured and wellfunded Office to support the coordination and collaboration of all ICs that can play a role in advancing the field represent an opportunity for NIH to both optimize its significant resources and to maximize the ground covered by the research it conducts.


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