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Pages 411-442

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From page 411...
... Inflammatory Bowel Diseases 24(6)
From page 413...
... population, with consequences that compromise quality of life for those afflicted. Many autoimmune diseases affect women predominantly, and the incidence and prevalence of these diseases appears to be rising in certain groups, such as children and adolescents in the case of two of the most common autoimmune diseases, namely inflammatory bowel disease and type 1 diabetes.
From page 414...
... Chapter 4 describes commonalities among autoimmune diseases. These commonalities suggest common immune pathways among some diseases or groups of diseases, including the role of genetics, biologic sex, and environmental exposures.
From page 415...
... Committee members reviewed IC strategic plans, websites, and other information to obtain insights into the autoimmune disease research priorities of the ICs reviewed and to identify which autoimmune diseases might be relevant to their missions. The committee notes that the lack of a central repository for autoimmune disease research at NIH hampers the ability of individuals in and outside of NIH, and in and outside of the research enterprise, to readily access this information and consequently limits transparency and communication with the public and other stakeholders.
From page 416...
... the funded grants represent the most promising, innovative, or impactful autoimmune disease research areas; (2) dollars are appropriately distributed by research topic area (e.g., crosscutting research, basic science, clinical science, specific autoimmune diseases)
From page 417...
... While the committee recognizes that the diffuse and investigator-initiated nature of NIH research, and of autoimmune disease research in particular, has many well-described and accepted advantages, this approach does not optimally promote these five elements given barriers identified by the committee. While several individual ICs address autoimmune diseases in strategic plans and may reference elements such as collaboration and evaluation, others do not.
From page 418...
... During the course of this review, the committee identified an opportunity not only for filling gaps that may fall between the work of diverse ICs, but also, as discussed in Chapter 4, capturing and leveraging an understanding of the crosscutting nature of autoimmune diseases, including their underlying common disease mechanisms, risk factors, and commonalities such as coexisting illnesses. The committee believes that emerging and evolving science now makes those connections more achievable than ever before.
From page 419...
... Such an office would be positioned to respond to the committee's concerns by: • Facilitating cross-NIH multidisciplinary collaboration and stimu lating innovation around autoimmune disease research; • Engaging in priority setting, strategic planning, and implemen tation; • Budgeting for and allocating available autoimmune disease research funds in alignment with the strategic plan; • Managing and evaluating autoimmune disease research efforts; • Communicating with key stakeholders; and • Providing visible leadership on autoimmune disease research. Option 1: Increased Funding for Autoimmune Disease Research Given the flat line of research spending levels over the past 12 years, the committee believes that increased funding will be an indispensable component of any effort to enhance autoimmune disease research opportunities, and thus it lists that option first.
From page 420...
... • Funding increases are uncertain/unpredictable, making planning difficult. • Unhelpful competition for limited new resources among ICs -- and among autoimmune diseases research areas.
From page 421...
... Autoimmune Disease Coordinating Committee • Would raise the visibility of autoimmune diseases to the cabinet level. • Engages and potentially leverages other HHS agencies, including their expertise, resources, and reach.
From page 422...
... Benefits and • Internal and external accountability and transparency for Advantages autoimmune disease research may improve. • May provide, though to a lesser extent, many of the benefits of a new Institute enumerated in Option 4, with fewer bureaucratic and other costs or controversies.
From page 423...
... Increased funding directed to certain focused autoimmune disease research activities and initiatives is another alternative. Several focused activities, such as the Autoimmunity Centers of Excellence (ACEs)
From page 424...
... Given these considerations, the committee notes that funding by itself is necessary but not sufficient for enhancing the research enterprise for autoimmune diseases; it does not address issues of coordination, prioritization, or workforce development. Option 2a: Coordination by Revitalizing the ADCC The ADCC, NIH's current coordinating mechanism for research on autoimmune diseases, was most active between 1998 and 2005, when it produced reports summarizing the state of autoimmune disease research and funding (2000)
From page 425...
... SAMHSA could be informed and benefit from NIH research on co-occurring mental health issues related to autoimmune diseases and could provide information on potential areas needing NIH research. An added benefit of elevating this issue to the cabinet level is that it would
From page 426...
... . While no analogy between diseases or the state of research for two conditions is ever perfect, there are similarities between Alzheimer's and certain autoimmune diseases in terms of the significant numbers 3 Available at https://www.nia.nih.gov/research/milestones.
From page 427...
... In some cases, research is in its infancy, treatments are limited, and there are no cures. Most importantly, no overall architecture for Alzheimer's disease research existed before developing the National Plan, and one does not exist for autoimmune disease research.
From page 428...
... Such an Institute would have significant advantages. A new Institute would likely elevate the visibility and status of autoimmune disease within NIH and externally, and it would assure a high-level, constant, broad, and detailed focus on autoimmune disease research.
From page 429...
... In the first, OAD/AR would have its own research budget and it would substantially control certain key budgetary decisions about autoimmune disease research activities conducted elsewhere in NIH, the Office of AIDS Research (OAR) serves as a model for this configuration.
From page 430...
... Based on these reviews, the Committee concludes that OAR can provide a highly desirable model for a new Office of Autoimmune Disease/Autoimmunity Research. This organizational model has provided such important elements for coordinating HIV and HIV-related research through: • Advice provided to the Director of NIH, HHS, and other entities on HIV and HIV-related research; • Establishment of research priorities/goals; • Development and annual evaluation of a strategic plan for HIV and HIV-related research throughout NIH; • Assurance that funds are invested in the areas of scientific priority and such funding is allocated; • Oversight, coordination, and management of HIV and HIV related research (scientific, budgetary, legislative, and policy)
From page 431...
... . Using OAR as a model, the committee believes that a well-configured OAD/AR could be an essential ingredient in further stimulating promising and impactful autoimmune disease and autoimmunity research at NIH that can be translated into clinical practices that will prevent autoimmune disease or improve the lives of those living with autoimmune disease.
From page 432...
... Strengthening outreach could also inform funding for other important research priorities undertaken by various ICs. In support of strategic planning, the Office, in collaboration with ICs and other stakeholders, should develop a consensus vocabu lary that includes both clinically defined autoimmune diseases and autoimmune mechanisms and a list of autoimmune diseases.
From page 433...
... 5. Coordinating with the Center for Scientific Review to review assignment guidelines to ensure that autoimmune diseases grants are assigned to the appropriate study sections with optimal representation of experts and expertise, including expertise for reviewing basic science (i.e., tissue culture, ani mal, translational)
From page 434...
... On balance, the committee believes that the advantages of creating an Office significantly outweigh the disadvantages. Such an Office has potential promise and impact in expanding both the frontiers and nearterm impacts of autoimmune disease research.
From page 435...
... population-based epidemiology studies on autoimmune disease.  Such studies would allow for assessing trends, identifying differences among population subgroups, and determining the prevalence and incidence of under-researched autoimmune diseases and conditions, such as celiac disease. The National Cancer Institute's Surveillance, Epidemiology, and End Results Program, which provides information on cancer incidence and survival in the United States, is a model for such studies that already exists at NIH.
From page 436...
... Early life exposures and timing of these exposures influence health at different life stages at a population and individual patient level. Autoimmune diseases are long-lasting and heterogeneous conditions for which manifestations and coexisting morbidities change over time.
From page 437...
... Prioritized research streams should include, but need not be limited to, clinical and basic research that addresses the research streams below. Heterogeneity in autoimmune diseases takes many forms, which could range from differences in symptom presentation and disease progression, as seen in persons with systemic lupus erythematosus, to severity of disease, as observed in myocarditis in men compared with women, to varying responses to the same therapy.
From page 438...
... influence autoimmune disease, examining the effect of puberty, pregnancy, and menopause to understand sex differences in autoimmune diseases • Identify autoantigens across autoimmune diseases using new technologies that allow T-cell receptors identified by single cell RNA sequencing from tissue to be interrogated without bias transfecting mRNA libraries into reporter antigen presenting cells • Dissect molecular mechanisms associated with poor outcomes • Design research that bridges animal models and human studies to better understand common mechanisms in inflammation for specific autoimmune diseases Researching less common autoimmune diseases can be difficult owing to smaller pools of persons affected. At the same time, identifying genetic variants, for example, could reveal insights that might be applied to more common diseases.
From page 439...
... influence autoantibody levels/types and/ or immune complex formation that are diagnostic or pathologi cal for autoimmune diseases • Explore the pipeline for development and validation of auto antibodies as disease biomarkers and surrogate endpoints of disease • Identify novel biomarkers and complex "signatures" that pre dict and diagnose autoimmune diseases including cytokines, microRNAs and other markers As discussed in Chapter 2 and Chapter 4, genetics, and particularly gene variants, environmental exposures, and timing interact to increase or blunt an individual's susceptibility to autoimmune diseases. Identifying the biological functions of gene variants and the effects of environmental exposures on their functions over time could reveal new avenues for care.
From page 440...
... and social determinants of health in children and adults, including stress, for individual and/or multiple autoimmune diseases, including disease flares • Determine the effect of environmental exposures on immune pathways in patients and animal models of autoimmune disease • Utilize a life-course approach along with advanced methodolo gies (e.g., computational science) to identify and examine the potential effect of interacting co-exposures that may increase susceptibility to disease, and to understand how these factors affect onset, progression, and severity of disease • Conduct a systematic investigation of the effects of nutrients, dietary antigens, exercise, aging, and microbiome in normal tissue development and homeostasis in the pre-clinical phase of disease and during disease and recovery • Explore novel methodologies to identify distinct and interacting biological and biopsychosocial factors contributing to observed sex/gender differences in autoimmune diseases, including the effect of puberty, menopause, and pregnancy on autoimmune diseases
From page 441...
... • Investigate the occurrence of and risk factors for disease com plications (e.g., functional impairment, disability, growth impairment) , co-occurring autoimmune diseases, coexisting morbidities (e.g., cardiovascular disease, cancer)
From page 442...
... Foster research to advance health equity for all autoimmune disease patients. • Investigate genetic, biological, and social determinants, and environmental mechanisms of autoimmune diseases in differ ent racial, ethnic, and other underrepresented groups, as well as across sexes and over the lifespan • Identify individuals at high risk of autoimmune diseases and implement prevention strategies • Investigate disparities and determinants of disparities in dis ease stage at presentation and progression of disease, including complications, coexisting morbidities, functional impairments, and disability • Explore novel methodologies to identify distinct and inter acting biological and biopsychosocial factors contributing to observed sex differences in autoimmune diseases • Collaborate with consumers, community-based organizations, and other partners to develop and evaluate health care delivery and/or policy interventions to address identified disparities and generate evidence to support their feasibility, sustainability, and dissemination • Build long-term partnerships between patients, communities, clinicians, and scientists to increase participation of under served populations in interventional clinical trials and other clinical and translational research studies • Conduct dissemination/implementation research to determine best practices and to improve outcomes for all • Conduct research on how to increase recruitment of under served populations in clinical research, and in interventional clinical trials in particular • Conduct research on how best to target interventions for patients with worse outcomes and/or underserved populations Chapter 2 noted that rates of many autoimmune diseases are rising.


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