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6 Analysis of Institute and Center Autoimmune Disease Research Activity
Pages 345-410

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From page 345...
... NIH's investment in autoimmune disease research has remained constant at about 2.8 percent of its total obligations between 2008 and 2020 (Figure 6-1) .1,2 From 2015 to 2020, total NIH obligations increased by 40 percent, whereas autoimmune disease spending increased by approximately 34 percent.
From page 346...
... 346 PREPUBLICATION COPY -- Uncorrected Proofs FIGURE 6-1  NIH Actual total obligations and autoimmune disease spending, FY 2008–2020.
From page 347...
... FIGURE 6-2  NIH Autoimmune disease spending, FY 2008–2020. PREPUBLICATION COPY -- Uncorrected Proofs NOTE: FY, Fiscal Year.
From page 348...
... is not an Institute but is included because of its funding contributions to autoimmune disease research. FY, Fiscal Year; IC, Institutes and Centers; NCATS, National Center for Advancing Translational Sciences; NCI, National Cancer Institute; NEI, National Eye Institute; NHGRI, National Human Genome Research Institute; NHLBI, National Heart, Lung, and Blood Institute; NIAID, National Institute of Allergy and Infectious Diseases; NIAMS, National Institute of Arthritis and Musculoskeletal and Skin Diseases; NICHD, Eunice Kennedy Shriver National Institute of Child Health and Human Development; NIDCR, National Institute of Dental and Craniofacial Research; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases; NIEHS, National Institute of Environmental Health Sciences; NIGMS, National Institute of General Medical Sciences; NINDS, National Institute on Neurological Disorders and Stroke; OD, Office of the Director.
From page 349...
... The committee used RePORTER activity code data to assess autoimmune disease research activities by extramural research (R and P grants) ; cooperative agreements (U grants)
From page 350...
... is not an Institute but is included because of its funding contributions to autoimmune disease research. FY, Fiscal Year; IC, Institutes and Centers; NCATS, National Center for Advancing Translational Sciences; NCI, National Cancer Institute; NEI, National Eye Institute; NHGRI, National Human Genome Research Institute; NHLBI, National Heart, Lung, and Blood Institute; NIAID, National Institute of Allergy and Infectious Diseases; NIAMS, National Institute of Arthritis and Musculoskeletal and Skin Diseases; NICHD, Eunice Kennedy Shriver National Institute of Child Health and Human Development; NIDCR, National Institute of Dental and Craniofacial Research; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases; NIEHS, National Institute of Environmental Health Sciences; NIGMS, National Institute of General Medical Sciences; NINDS, National Institute on Neurological Disorders and Stroke; OD, Office of the Director.
From page 351...
... Cooperative Agreements Cooperative agreements are a sup port mechanism frequently used for complex, high-priority research U Cooperative Agreements areas that require substantial involvement from NIH program or scientific staff. Fellowships, Training, Training Centers Fellowships provide individual research training opportunities F Fellowship Programs (including international)
From page 352...
... Among the smaller ICs, NIAMS had a significantly higher level of funding in 2020 and average of funding for 2008–2020 for grants to support autoimmune disease research (R) compared to other small ICs.
From page 353...
... , and research Program project and center (P) grants, FY 2008–2020 (in millions)
From page 354...
... SOURCE: NIH, 2021f. TABLE 6-5  Training Investment for Selected RCDC Spending Categories, FY 2020 RCDC Spending Fellow Category ship Research Career Training FY 2020 Total Alzheimer's 10.9% 72.5% 16.5% $47,440,000 Autoimmune Disease 12.1% 76.9% 11.0% $43,646,000 Breast Cancer 0.8% 2.2% 0.0% $717,665,000 Cardiovascular 9.4% 64.3% 26.3% $144,080,000 COPD 12.2% 87.8% 0.0% $7,531,000 NOTE: COPD, Chronic Obstructive Pulmonary Disease; FY, Fiscal Year; RCDC, Research, Condition, and Disease Categorization.
From page 355...
... Table 6-6 shows IC funding of training grants that support the autoimmune disease research workforce. In FY 2020, NIDDK, NIAID, and NHLBI had the highest level of funding for fellowship (F)
From page 356...
... 356 ENHANCING NIH RESEARCH ON AUTOIMMUNE DISEASE TABLE 6-6  Training Grant Funding for Autoimmune Disease Research by Institute and Year Training as a Percent of FY 2020 Obliga Institute Year(s) F K T tions FY 2020 $171,195 $584,384 $0 NCI 0.01% Average FY 2008–2020 $100,885 $349,586 $0 FY 2020 $814,263 $2,085,385 $653,017 NIAID 0.06% Average FY 2008–2020 $492,310 $2,454,588 $561,823 FY 2020 $804,583 $4,432,189 $0 NHLBI 0.14% Average FY 2008–2020 $442,446 $2,737,751 $0 FY 2020 $79,212 $198,504 $0 NIGMS 0.01% Average FY 2008–2020 $135,591 $118,849 $0 FY 2020 $432,647 $3,359,470 $0 NINDS 0.16% Average FY 2008–2020 $586,329 $2,324,825 $0 FY 2020 $2,062,032 $11,311,126 $93,836 NIDDK 0.61% Average FY 2008–2020 $1,640,982 $9,848,175 $159,663 FY 2020 $82,851 $570,283 $0 NICHD 0.04% Average FY 2008–2020 $26,922 $553,745 $0 FY 2020 $36,611 $87,463 $0 NIEHS 0.01% Average FY 2008–2020 $67,663 $65,037 $0 FY 2020 $0 $0 $0 NCATS Average FY 2008–2020 $0 $0 $0 FY 2020 $0 $916,394 $0 NEI 0.11% Average FY 2008–2020 $14,717 $828,068 $0 FY 2020 $281,015 $8,247,061 $3,953,872 NIAMS 2.00% Average FY 2008–2020 $229,852 $7,926,922 $4,261,852 FY 2020 $64,926 $0 $0 NHGRI 0.01% Average FY 2008–2020 $4,994 $62,014 $0 FY 2020 $107,672 $0 $0 NIDCR 0.02%  Average FY 2008–2020 $65,626 $139,637 $0 FY 2020 $0 $1,175,676 $85,655 OD 0.09% Average FY 2008–2020 $9,502 $491,711 $12,694 continued PREPUBLICATION COPY -- Uncorrected Proofs
From page 357...
... INSTITUTE AND CENTER AUTOIMMUNE DISEASE RESEARCH 357 TABLE 6-6 Continued NOTE: FY, Fiscal Year; IC, Institutes and Centers; NCATS, National Center for Advancing Translational Sciences; NCI, National Cancer Institute; NEI, National Eye Institute; NHGRI, National Human Genome Research Institute; NHLBI, National Heart, Lung, and Blood Institute; NIAID, National Institute of Allergy and Infectious Diseases; NIAMS, National Institute of Arthritis and Musculoskeletal and Skin Diseases; NICHD, Eunice Kennedy Shriver National Institute of Child Health and Human Development; NIDCR, National Institute of Dental and Craniofacial Research; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases; NIEHS, National Institute of Environmental Health Sciences; NIGMS, National Institute of General Medical Sciences; NINDS, National Institute on Neurological Disorders and Stroke; OD, Office of the Director.
From page 358...
... FY, Fiscal Year; IC, Institutes and Centers; NI AID, National Institute of Allergy and Infectious Diseases; NCI, National Cancer Institute; NICHD, Eunice Kennedy Shriver National Institute of Child Health and Human Development; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases; PREPUBLICATION COPY -- Uncorrected Proofs NIGMS, National Institute of General Medical Sciences; NHLBI, National Heart, Lung, and Blood Institute; NINDS, National In stitute of Neurological Disorders and Stroke.
From page 359...
... National Center for Advancing Translational Sciences (NCATS) was not included in the figure because it became an Institute in 2012; In FY PREPUBLICATION COPY -- Uncorrected Proofs 2020, NCATS spent $226,174 on autoimmune disease research grants and an average of $493,918 per year over the FY 2008–2020 period.
From page 360...
... FY, Fiscal Year; IC, Institutes and Centers; NIAID, National Institute of Allergy and Infectious Diseases; NCI, National Cancer Institute; NICHD, Eunice Kennedy Shriver PREPUBLICATION COPY -- Uncorrected Proofs National Institute of Child Health and Human Development; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases; NIGMS, National Institute of General Medical Sciences; NHLBI, National Heart, Lung, and Blood Institute; NINDS, National Institute of Neurological Disorders and Stroke.
From page 361...
... FY, Fiscal Year; IC, Institutes and Centers; NIAMS, National Institute of PREPUBLICATION COPY -- Uncorrected Proofs Arthritis and Musculoskeletal and Skin Diseases; NIEHS, National Institute of Environmental Health Sciences; NEI, National Eye Institute; NIDCR, National Institute of Dental and Craniofacial Research.
From page 362...
... did not have any P grant spending between 2012 and 2020. PREPUBLICATION COPY -- Uncorrected Proofs IC, Institutes and Centers; FY, Fiscal Year; NIAID, National Institute of Allergy and Infectious Diseases; NIAMS, National Institute of Arthritis and Musculoskeletal and Skin Disorders; NCI, National Cancer Institute; NHLBI, National Heart, Lung, and Blood Institute; NIGMS, National Institute of General Medical Sciences; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases; NINDS, National Institute of Neurological Disorders and Stroke.
From page 363...
... NIDDK solicited research funding was 2.7 times higher than NIAID funding for this grant type. Intramural research activities represent 17.3 percent of NIH funding for autoimmune research in FY 2020. A total of 50 intramural principal investigators conduct autoimmune disease research, which may include basic, translational, and clinical studies. However, the committee notes that there is a relative lack of intramural principal investigators who focus on epidemiology and autoimmune diseases.
From page 364...
... and Combined Total Cost of Funded Autoimmune Disease Research. Grants without an FOA were not included in the analysis.
From page 365...
... TABLE 6-7  Intramural, Investigator-Initiated, and Solicited Autoimmune Disease Research by IC, FY 2020 and Average FY 2008–2020 Institute Intramural Investigator-Initiated Solicited Average Average Average FY 2020 FY FY 2020 FY FY 2020 FY   2008–2020 2008–2020 2008–2020 NCI $14,270,000 $10,882,000 $11,684,000 $10,347,000 $9,416,000 $2,074,000 NIAID $34,006,000 $21,769,000 $187,328,000 $107,751,000 $55,735,000 $42,976,000 NHLBI $11,701,000 $4,077,000 $59,078,000 $39,906,000 $5,593,000 $14,307,000 NIGMS $0 $0 $15,026,000 $10,947,000 $629,000 $1,744,000 NINDS $13,474,000 $9,765,000 $54,562,000 $50,127,000 $11,350,000 $3,113,000 NIDDK $7,566,000 $4,921,000 $185,951,000 $127,257,000 $153,690,000 $120,316,000 NICHD $1,964,000 $3,444,000 $7,844,000 $8,163,000 $709,000 $1,855,000 NIEHS $4,724,000 $7,439,000 $4,602,000 $4,202,000 $2,101,000 $1,170,000 NCATS $2,606,000 $1,564,000 $590,000 $472,000 $2,801,000 $2,801,000 NEI $14,983,000 $9,614,000 $18,624,000 $10,587,000 $376,000 $128,000 NIAMS $35,790,000 $28,182,000 $86,159,000 $72,297,000 $25,767,000 $20,573,000 NHGRI $7,003,000 $3,945,000 $65,000 $371,000 $3,401,000 $6,688,000 NIDCR $4,930,000 $7,740,000 $13,950,000 $6,191,000 $0 $1,350,000 PREPUBLICATION COPY -- Uncorrected Proofs OD $0 $0 $3,316,000 $4,668,000 $11,595,000 $15,929,000 365
From page 366...
... These diseases include inflammatory bowel disease, multiple sclerosis, type 1 diabetes, rheumatoid arthritis, systemic lupus erythematous, Sjögren's disease, psoriasis, celiac disease, autoimmune thyroid disease, antiphospholipid syndrome, and primary biliary cholangitis. Hashimoto's disease and Grave's disease were combined into a single "autoimmune thyroid disease" category.
From page 367...
... . NOTES: Percentages in the figure add up to be more than 100 percent because grants can be associated with more than one auto immune disease.
From page 368...
... . NOTES: Percentages in the figure add up to be more than 100 percent because grants can be associated with more than one auto immune disease.
From page 369...
... . Figure 6-18 FIGURE 6-12  Top 10 activity codes for autoimmune disease research.
From page 370...
... 370 PREPUBLICATION COPY -- Uncorrected Proofs FIGURE 6-13  Number of R01 grants by autoimmune disease, FY 2008–2020. NOTE: FY, Fiscal Year.
From page 371...
... PREPUBLICATION COPY -- Uncorrected Proofs FIGURE 6-14  Number of non-competing continuation R01 grants (n=2,751) by autoimmune disease, FY 2008–2020.
From page 372...
... To assess the level of collaboration among ICs, the committee examined co-funded autoimmune disease research grants for FY 2008–2020. To accomplish this, the committee used NIH RePORTER data to identify administrative ICs funding autoimmune disease research grants and corresponding funding ICs that contributed to the total cost of grants during this period.
From page 373...
... PREPUBLICATION COPY -- Uncorrected Proofs FIGURE 6-15  New R01 grants by autoimmune disease (N=1,892)
From page 374...
... . NOTES: Percentages do not sum to 100 percent because the figure includes only the top 10 funding ICs and does not include grants without a funding IC listed in NIH RePORTER.
From page 375...
... PREPUBLICATION COPY -- Uncorrected Proofs FIGURE 6-17  NIDDK (funding IC) grants by disease, FY 2008–2020.
From page 376...
... 376 PREPUBLICATION COPY -- Uncorrected Proofs FIGURE 6-18  NIAID (funding IC) grants by disease, FY 2008–2020.
From page 377...
... PREPUBLICATION COPY -- Uncorrected Proofs FIGURE 6-19  NIAMS (funding IC) grants by disease, FY 2008–2020.
From page 378...
... statistical modeling to identify research topics in the set of 8,470 NIH research abstracts related to autoimmune disease grants funded between 2008 and 2020. Topic modeling using LDA is a method of fitting a pre-determined number of topics to a set of texts.
From page 379...
... All ICs in this table are administrative ICs. FY, Fiscal Year; IC, Institutes and Centers; NCATS, National Center for Advancing Translational Sciences; NCI, National Cancer Institute; NEI, National Eye Institute; NHGRI, National Human Genome Research Institute; NHLBI, National Heart, Lung, and Blood Institute; NIAID, National Institute of Allergy and Infectious Diseases; NIAMS, National Institute of Arthritis and Musculoskeletal and Skin Diseases; NICHD, Eunice Kennedy Shriver National Institute of Child Health and Human Development; NIDCR, National Institute of Dental and Craniofacial Research; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases; NIEHS, National Institute of Environmental Health Sciences; NIGMS, National Institute of General Medical Sciences; NINDS, National Institute on Neurological Disorders and Stroke; OD, Office of the Director.
From page 380...
... In Figure 6-21, immune response (innate immunity) may be disproportionately high because of its relevance to various aspects of autoimmune disease research as well as a lack of a concrete definition for innate immunity.
From page 381...
... PREPUBLICATION COPY -- Uncorrected Proofs FIGURE 6-20  LDA-generated topics for NIH autoimmune disease grants, FY 2008–2020: Disease focused topics. NOTE: SLE, systemic lupus erythematosus; IBD, inflammatory bowel disease.
From page 382...
... In other words, this method cannot be used to actively search for specific research topics. RCDC Spending Categories The second approach the committee used to evaluate the NIH research portfolio was to determine which other NIH RCDC spending categories co-occur with the autoimmune disease spending category.
From page 383...
... PREPUBLICATION COPY -- Uncorrected Proofs FIGURE 6-21  LDA-generated topics for NIH autoimmune disease grants, FY 2008–2020: Immune response related topics.
From page 384...
... SOURCE: NIH, 2021f. FIGURE 6-23  LDA-generated topics for NIH autoimmune disease grants, FY 2008–2020: Administrative topics.
From page 385...
... INSTITUTE AND CENTER AUTOIMMUNE DISEASE RESEARCH 385 TABLE 6-9  Percent of Autoimmune Disease Grants Co-occurring with other RCDC Spending Categories (N=8,470) Co-Occurring with Autoimmune Disease RCDC Spending Category Spending Category Genetics 2,718 32.1% Biotechnology 1,978 23.4% Prevention 1,938 22.9% Pediatric 1,349 15.9% Women's Health 1,095 12.9% Infectious Disease 1,007 11.9% Aging 688 8.1% Cancer 660 7.8% Minority Health 590 7.0% Cardiovascular 490 5.8% Immunotherapy 388 4.6% Eye Disease and Disorders of Vision 327 3.9% Microbiome 298 3.5% Biomedical Imaging 176 2.1% Precision Medicine 157 1.9% Pain Research 143 1.7% Health Services 132 1.6% Estrogen 71 0.8% Chronic Pain 56 0.7% Acquired Cognitive Impairment 49 0.6% Depression 42 0.5% Cerebrovascular 41 0.5% Fibromyalgia 14 0.2% Burden of Illness 12 0.1% Caregiving Research 2 0.0% SOURCE: NIH, 2021f.
From page 386...
... Alternatively, depression as both an RCDC category and a PICO Portal research characteristic tag both occurred infrequently in autoimmune disease grants (0.5 percent)
From page 387...
... . NOTE: Percentages in the figure add up to be more than 100 percent because grants could be tagged with more than one research characteristic.
From page 388...
... nih.gov/StudySections, accessed November 24, 2021. The committee entered the name of each of the select autoimmune diseases of committee interest into the study section search field to identify the names of its associated chartered study sections.
From page 389...
... Table 6-1015 provides a snapshot of data generated by the RePORTER Matchmaker tool. The table shows study sections -- the names of which appear in the far left column -- that reviewed funded grants focusing on the autoimmune diseases of interest to the committee; the table reflects a two-year period.16,17 The table identifies those study sections that reviewed the most funded grants for each disease of focus according to a bar graph RePORTER automatically generates to provide this information; the number of grants are indicated in the corresponding cells.
From page 390...
...   Celiac Sjögren's Psoria- Crohn's Hashimoto's SLE APS RA IBD Dis- PBC MS T1D Disease sis Disease Thyroiditis ease Gastrointestinal Muco 25 1 13 sal Pathobiology Hypersensitivity, Auto immune and Immune- 11 6 6 9 Mediated Diseases Arthritis, Connective 8 6 3 Tissue and Skin Oral, Dental and Cra- 2 7 4 niofacial Science Cellular and Molecular 3 1 4 3 Immunology B Clinical Neuroimmu nology 11 and Brain Tumor Innate Immunity 4 3 3 and Inflammation PREPUBLICATION COPY -- Uncorrected Proofs Cellular and Molecular 8 Biology of Glia
From page 391...
...   Celiac Sjögren's Psoria- Crohn's Hashimoto's SLE APS RA IBD Dis- PBC MS T1D Disease sis Disease Thyroiditis ease Clinical and Integrative 8 Diabetes and Obesity Cellular Aspects of 6 Diabetes and Obesity Hepatobiliary Patho 6 physiology Skeletal Biology and 3 Developmental Disease Diseases and Pathol ogy 2 of the Visual System Molecular and Cellular 2 Endocrinology Atherosclerosis and Inflammation of the 1 Cardiovascular System Cellular Signaling and Regulatory Sys- 1 PREPUBLICATION COPY -- Uncorrected Proofs tems continued 391
From page 392...
... Table reflects data available as of October 5, 2021. NOTE: APS, antiphospholipid syndrome; IBD, inflammatory bowel disease; MS, multiple sclerosis; PBC, primary biliary cholangitis; RA, rheuma toid arthritis; SLE, systemic lupus erythematosus; T1D, type 1 diabetes SOURCE: NIH, 2021f.
From page 393...
... Clinical trials were fewer for the remaining autoimmune diseases. 18Grants with an RCDC code for "Autoimmune Disease" obtained from NIH RePORTER for Fiscal Year 2008 (October 1, 2008–September 30, 2008)
From page 394...
... . PREPUBLICATION COPY -- Uncorrected Proofs NOTE: Percentages in the figure add up to be more than 100 percent because clinical trials can be associated with more than one autoimmune disease.
From page 395...
... Figure 6-2720 shows publications by disease category per year. Of the autoimmune diseases examined, the four diseases associated with the greatest number of publications over the 2008–2020 period were other autoimmune disease TABLE 6-11  Phase 4 Clinical Trials, Autoimmune Disease Prevention or Treatment Condition or Primary Official Title Disease Purpose RHYTHM (RHeumatoid Arthritis studY of THe Myocardium)
From page 396...
... , and JIF is a measure of journal quality exclusively. In the context of evaluating NIH's autoimmune disease portfolio, the committee focused on publications resulting from NIH-funded autoimmune disease research and the quality of the journals in which they are published.
From page 397...
... . PREPUBLICATION COPY -- Uncorrected Proofs NOTE: Percentages in the figure add up to be more than 100 percent because publications can be associated with more than one autoimmune disease.
From page 398...
... 398 PREPUBLICATION COPY -- Uncorrected Proofs FIGURE 6-28  Number of autoimmune disease publications by disease and year, 2008–2020. SOURCES: Clarivate, 2021; NIH, 2015, 2021f; NLM, 2021b.
From page 399...
... . Patents granted as a result of NIH-funded autoimmune disease research aim to encourage and protect biomedical innovation and may serve as a proxy for knowledge generation and translational value in the field (Kalutkiewicz and Ehman, 2014)
From page 400...
... JIF, Journal Impact Factor. SOURCES: Clarivate, 2021; NIH, 2015, 2021f; NLM, 2021b.
From page 401...
... 26 Autoimmune Disease Research Highlights were collected from NIH biennial and trien nial reports to congress, and NIH websites. PREPUBLICATION COPY -- Uncorrected Proofs
From page 402...
... . NOTE: Percentages in the figure add up to be more than 100 percent because patents can be associated with more than one auto immune disease.
From page 403...
... . NOTE: Percentages in the figure add up to be more than 100 percent because patents can be associated with more than one auto immune disease.
From page 404...
... This finding paves the way for Research on Interferons Could "precision-based medicine," a customized treatment Identify Individuals with approach which tailors health care based on a person's Sjögren's Disease Most Likely genes to those patients most likely to respond to certain to Respond to Treatment therapies, such as anti-IFN treatments. In addition, it could improve the selection of for clinical trials.
From page 405...
... Better outcomes such as improvement in bone marrow and "resetting" of the immune system are associated with such factors for patients as younger age, fewer prior immunotheraStem Cell Transplants Leads pies and not having reached high disability levels. For to Positive Outcomes for Mul researchers, such results justify a future clinical trial tiple Sclerosis Patients on stem cell transplants for treating MS including an evaluation of safety and efficacy against approved therapies of high efficacy.
From page 406...
... . Inflammatory bowel disease Because irritable bowel disease makes it difficult for food nutrients to be absorbed, growth in children who have ulcerative colitis (a type of IBD limited to the co lon)
From page 407...
... NIH may need to reconsider the current strong focus on investigatorinitiated research in order to target areas of high priority and effectively address the long-term, complex, and heterogeneous nature of autoimmune diseases. Regarding the activities conducted under funded autoimmune disease research grants, the multiple methods the committee used yielded PREPUBLICATION COPY -- Uncorrected Proofs
From page 408...
... The outputs of NIH's investment in autoimmune disease research can be measured in a variety of ways, including clinical trials (the translation of research knowledge into interventions) , publications, and the number of patents associated with autoimmune research grants (an important indicator of innovation)
From page 409...
... 2021. Autoimmune disease research supported by extramural NIAID.
From page 410...
... https://clinical trials.gov/ct2/about-studies/glossary (accessed December 14, 2021)


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