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From page 345... ... have a greater focus on autoimmune diseases tied to their mission, and thus there is considerable variation in the level of spending on autoimmune disease research activities. The OD also contributes funds to support autoimmune disease research activities. Read the entire page →
From page 346... ... 346 FIGURE 6-1 NIH actual total obligations and autoimmune disease spending, FY 2008–2020. Read the entire page →
From page 347... ... FIGURE 6-2 NIH autoimmune disease spending, FY 2008–2020. NOTE: FY, fiscal year. Read the entire page →
From page 348... ... is not an institute but is included because of its funding contributions to autoimmune disease research. FY, fiscal year; IC, Institute or Center; 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 of Neurological Disorders and Stroke; OD, Office of the Director. Read the entire page →
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) Read the entire page →
From page 350... ... is not an institute but is included because of its funding contributions to autoimmune disease research. FY, fiscal year; IC, Institute or Center; 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 of Neurological Disorders and Stroke; OD, Office of the Director. Read the entire page →
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) Read the entire page →
From page 352... ... . IC FUNDING OF GRANTS To explore ICs' use of grants to further autoimmune disease research, the committee examined IC funding for research (R) Read the entire page →
From page 353... ... FIGURE 6-3 NIH autoimmune disease funding by research (R) , cooperative agreement (U) Read the entire page →
From page 354... ... SOURCE: NIH, 2021f. TABLE 6-5 Training Investment for Selected RCDC Spending Categories, FY 2020 RCDC Spending Research FY 2020 Category Fellowship Career Training 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. Read the entire page →
From page 355... ... Among the larger ICs (Figure 6-6) , NIDDK had a significantly higher level of funding for U grants for autoimmune disease research activities in FY 2020 and over the FY 2008–2020 period. Read the entire page →
From page 356... ... 356 ENHANCING NIH RESEARCH ON AUTOIMMUNE DISEASE TABLE 6-6 Training Grant Funding for Autoimmune Disease Research by IC and FY Training as a Percent of FY 2020 IC Year(s) F K T Obligations 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 Read the entire page →
From page 357... ... INSTITUTE AND CENTER AUTOIMMUNE DISEASE RESEARCH 357 TABLE 6-6 Continued NOTE: FY, fiscal year; IC, Institute or Center; 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 of Neurological Disorders and Stroke; OD, Office of the Director. Read the entire page →
From page 358... ... FY, fiscal year; IC, Institute or Center; NIAID, 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; NIGMS, National Institute of General Medical Sciences; NHLBI, National Heart, Lung, and Blood Institute; NINDS, National Institute of Neurological Disorders and Stroke. Read the entire page →
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 2020, NCATS spent $226,174 on autoimmune disease research grants and an average of $493,918 per year over the FY 2008–2020 period. Read the entire page →
From page 360... ... FY, fiscal year; IC, Institute or Center; NIAID, 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; NIGMS, National Institute of General Medical Sciences; NHLBI, National Heart, Lung, and Blood Institute; NINDS, National Institute of Neurological Disorders and Stroke. Read the entire page →
From page 361... ... FY, fiscal year; IC, Institute or Center; NIAMS, National Institute of Arthritis ind Musculoskeletal and Skin Diseases; NIEHS, National Institute of Environmental Health Sciences; NEI, National Eye Institute; NIDCR, National Institute of Dental and Craniofacial Research. Read the entire page →
From page 362... ... , Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) , National Human Genome Research Institute (NHGRI) Read the entire page →
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 disease 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. Read the entire page →
From page 364... ... and Combined Total Cost of Funded Autoimmune Disease Research. Grants without an FOA were not included in the analysis. Read the entire page →
From page 365... ... TABLE 6-7 Intramural, Investigator-Initiated, and Solicited Autoimmune Disease Research by IC, FY 2020 and Average FY 2008–2020 IC 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 OD $0 $0 $3,316,000 $4,668,000 $11,595,000 $15,929,000 continued 365 Read the entire page →
From page 366... ... and combined total cost of funded autoimmune disease research variables. Grants without an FOA were not included in the analysis. Read the entire page →
From page 367... ... Of the autoimmune diseases the committee examined, the four diseases with the greatest number of funded grants over the FY 2008–2020 period were other autoimmune diseases (31.0 percent) , IBD (17.6 percent) Read the entire page →
From page 368... ... . NOTES: Percentages in the figure sum to more than 100 percent because grants can be associated with more than one autoimmune disease. Read the entire page →
From page 369... ... . NOTES: Percentages in the figure sum to more than 100 percent because grants can be associated with more than one autoimmune disease. Read the entire page →
From page 370... ... Figures 6-17 through 6-19 show trends in autoimmune diseases by the top three funding ICs (NIDDK, NIAID, and NIAMS) Read the entire page →
From page 371... ... FIGURE 6-13 Number of R01 grants by autoimmune disease, FY 2008–2020 (N=3,042) Read the entire page →
From page 372... ... 372 FIGURE 6-14 Number of non-competing continuation R01 grants by autoimmune disease, FY 2008–2020 (N=2,751) Read the entire page →
From page 373... ... The top three disease categories with the most grants were rheumatoid arthritis (orange) , other autoimmune diseases (light purple) Read the entire page →
From page 374... ... 374 FIGURE 6-15 New R01 grants by autoimmune disease, FY 2008–2020 (N=1,892) Read the entire page →
From page 375... ... FIGURE 6-16 Top 10 funding ICs by grants, FY 2008–2020 (N=8,470) Read the entire page →
From page 376... ... NIDDK was not necessarily the sole funder of each grant. FY, fiscal year; IC, Institute or Center; NIDDK, National Institute of Diabetes and Digestive Kidney Diseases. Read the entire page →
From page 377... ... FIGURE 6-18 NIAID (funding IC) grants by disease, FY 2008–2020 (N=1,671) Read the entire page →
From page 378... ... NIAMS was not necessarily the sole funder of each grant. FY, fiscal year; IC, Institute or Center; NIAMS, National Institute of Arthritis and Musculoskeletal and Skin Diseases. Read the entire page →
From page 379... ... 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. Read the entire page →
From page 380... ... All ICs in this table are administrative ICs. FY, fiscal year; IC, Institute or Center; 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 of Neurological Disorders and Stroke; OD, Office of the Director. Read the entire page →
From page 381... ... 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. Read the entire page →
From page 382... ... 382 FIGURE 6-20 LDA-generated topics for NIH autoimmune disease grants, FY 2008–2020: Disease focused topics. NOTE: IBD, inflammatory bowel disease; LDA, latent dirichlet allocation; SLE, systemic lupus erythematosus. Read the entire page →
From page 383... ... Given the large variation in the number of grants per disease, the committee decided to take random, weighted samples of the selected diseases as follows: a 10 percent sample of diseases with greater than 1,000 grants ("other autoimmune disease," IBD, multiple sclerosis, type 1 diabetes, rheumatoid arthritis, and SLE) , a 50 percent sample of diseases between 100 and 999 grants (Sjögren's, psoriasis, and celiac disease) Read the entire page →
From page 384... ... 384 FIGURE 6-21 LDA-generated topics for NIH autoimmune disease grants, FY 2008–2020: Immune response related topics. NOTE: FY, fiscal year; LDA, latent dirichlet allocation. Read the entire page →
From page 385... ... SOURCE: NIH, 2021f. FIGURE 6-23 LDA-generated topics for NIH autoimmune disease grants, FY 2008–2020: Administrative topics. Read the entire page →
From page 386... ... 386 ENHANCING NIH RESEARCH ON AUTOIMMUNE DISEASE 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. Read the entire page →
From page 387... ... Approximately 22 percent of the abstracts mentioned or focused on more than one autoimmune disease. In addition, the committee tagged abstracts based on the type of study researchers intended to conduct with their grant funding (Figure 6-25) Read the entire page →
From page 388... ... 388 FIGURE 6-24 Research characteristics identified within autoimmune disease grant abstracts (N=1,127) Read the entire page →
From page 389... ... 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. Read the entire page →
From page 390... ... 16 The committee used the RePORTER Matchmaker search tool available at https://reporter.nih.gov/matchmaker, accessed December 3, 2021. The committee entered the name of each of the select autoimmune diseases of committee interest into the field to yield the number of projects associated with that disease. Read the entire page →
From page 391... ... TABLE 6-10 Chartered Study Sections That Reviewed Funded Grants (FY 2019–2020) According to Select Autoimmune Diseases* Read the entire page →
From page 392... ... TABLE 6-10 Continued 392 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 tems Read the entire page →
From page 393... ... 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, rheumatoid arthritis; SLE, systemic lupus erythematosus; T1D, type 1 diabetes SOURCE: NIH, 2021f. Read the entire page →
From page 394... ... The committee obtained clinical trial data from clinicaltrials.gov18 and linked clinical trials to the grants associated with the committee's autoimmune diseases of interest. Clinical trials were de-duplicated using their Clinical Trial ID and included based on their relevance to the committee's specific diseases of interest and autoimmune disease as a broader category ("other autoimmune disease") Read the entire page →
From page 395... ... . NOTE: Percentages in the figure sum to more than 100 percent because clinical trials can be associated with more than one autoimmune disease. Read the entire page →
From page 396... ... 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) Read the entire page →
From page 397... ... , 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. Read the entire page →
From page 398... ... . NOTE: Percentages in the figure sum to more than 100 percent because publications can be associated with more than one autoimmune disease. Read the entire page →
From page 399... ... FIGURE 6-28 Number of autoimmune disease publications by disease and year, 2008–2020 (N=159,416) Read the entire page →
From page 400... ... . The committee examined patents and patent applications by autoimmune diseases. Read the entire page →
From page 401... ... FIGURE 6-29 Average JIF for the 10 journals with the highest JIF for all autoimmune disease publications, 2008–2020. NOTES: Because of the vast differences in the size of citation pools for general journals (large citation pools) Read the entire page →
From page 402... ... . Fewer patent applications were filed for the remaining autoimmune diseases. Read the entire page →
From page 403... ... . NOTE: Percentages in the figure sum to more than 100 percent because patents can be associated with more than one autoimmune disease. Read the entire page →
From page 404... ... . NOTE: Percentages in the figure sum to more than 100 percent because patents can be associated with more than one autoimmune disease. Read the entire page →
From page 405... ... . Systemic lupus erythematosus Unique "immune signatures" can identify pregnant patients with SLE who could suffer such complications as preeclampsia, high blood pressure and damage to organ systems such as the liver and kidneys, which endanger the mother, and death of a fetus as well as issues with fetal growth and preterm delivery. Read the entire page →
From page 406... ... 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. Read the entire page →
From page 407... ... . 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) Read the entire page →
From page 408... ... NIH may need to reconsider the current strong focus on investigator-initiated 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 Read the entire page →
From page 409... ... . There is a greater percentage of clinical trials from filing years 2008–2020 for such autoimmune diseases as type 1 diabetes, SLE, IBD, and rheumatoid arthritis, with a much smaller percentage seen for other autoimmune diseases. Read the entire page →
From page 410... ... Paper read at NASEM Committee for the Assessment of NIH Research on Autoimmune Diseases: Meeting 2 (Continuation) , February 1, 2021, Webinar. Read the entire page →

From page 345...

... have a greater focus on autoimmune diseases tied to their mission, and thus there is considerable variation in the level of spending on autoimmune disease research activities. The OD also contributes funds to support autoimmune disease research activities.