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American Recovery and Reinvestment Act (Stimulus Package)
NIH Challenge Grants in Health and Science Research
American Recovery and Reinvestment Act of 2009
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
March 4, 2009
NIH has received new funds for Fiscal Years 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 (Recovery Act), Pub. L. No. 111-5. The NIH has designated at least $200 million in FYs 2009 - 2010 for a new initiative called the NIH Challenge Grants in Health and Science Research.
This new program will support research on topic areas that address specific scientific and health research challenges in biomedical and behavioral research that would benefit from significant 2-year jumpstart funds.
The NIH has identified a range of Challenge Areas that focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. Each NIH Institute, Center, and Office has selected specific Challenge Topics within the broad Challenge Areas related to its mission. The research in these Challenge Areas should have a high impact in biomedical or behavioral science and/or public health.
NIH anticipates funding 200 or more grants, each of up to $1 million in total costs, pending the number and quality of applications and availability of funds. Proposals must be compliant with the requirements specified by the NIH Challenge Grants solicitation, and must be feasible with funding only in fiscal years 2009 and 2010. Projects that would require funding beyond this timeframe should provide a detailed plan for maintaining the research efforts without any expectation of further financial assistance from NIAMS or other NIH components.
In addition, Recovery Act funds allocated to NIH specifically for comparative effectiveness research (CER) may be available to support additional grants. Projects receiving these funds will need to meet this definition of CER: "a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy." Such research may include the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER.
NIAMS is grateful for the opportunity afforded by the American Recovery and Reinvestment Act to further our mission to invest in vital biomedical research related to diseases affecting the bones, joints, muscles and skin. As listed in the RFA for the NIH-wide Challenge Grants, NIH will fund meritorious research in many of our mission areas. NIAMS will consider funding meritorious applications submitted in response to this RFA beyond those that are funded by this NIH-wide Challenge Grant opportunity. We encourage you to apply for these funds.
The application due date is April 27, 2009.
Broad Challenge Areas and Specific Challenge Topics
(01) Behavior, Behavioral Change, and Prevention
01-AR-101 Integrating Behavioral And Biomedical Research Approaches In Arthritis And Musculoskeletal Diseases.
Behavioral and social factors are involved in numerous ways in the onset, course and outcomes of chronic diseases. These factors are central in the experience of symptoms (such as pain and fatigue), disease-related distress, ability to cope, disability and, to varying extents, the success of prevention and treatment approaches. Biopsychosocial research needs in rheumatic, musculoskeletal, and skin diseases include studies of biological mechanisms of psychosocial or behavioral processes related to disease progression, and genetic and environmental influences on behaviors relevant to disease onset. Integrated approaches would allow tailoring interventions based on disease phenotype, individual psychological or social characteristics, and provide evidence to translate knowledge into behavioral change such as adopting and adhering to treatment and preventive interventions. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
01-AR-102 Studies investigating variability in patient outcomes related to behavior.
Individuals differ tremendously in their response to clinical disease and symptoms. We seek studies to investigate the behavioral differences, sex differences, ethnic background, family environment, previous trauma, education, or combination of factors underlying the observed variability in outcomes in rheumatic, musculoskeletal and skin diseases. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
01-AR-103 Education As A Global Challenge.
Health outcomes are linked to both education and literacy. Disease education is currently targeted to affected populations by patient advocate groups. In the NIAMS mission areas, there is a paucity of disease and science education targeted to children and the general public as a whole through education, we have an opportunity to improve outcomes, feed the pipeline of underserved students entering research careers in NIAMS areas, educate the public on the purpose and results of NIAMS clinical trials, and reduce the stigma associated with disfiguring diseases which are plentiful in the NIAMS portfolio. One year awards of 100K to fund current science education programs in the USA are proposed. NIAMS would challenge existing education programs to integrate the NIAMS mission areas. We could encourage current NCRR Science Education Partnership Award (SEPA) recipients to apply. The SEPA programs are robust and these organizations have the potential to integrate our areas of interest into educational models that are developed or in the process of development. Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(02) Bioethics
02-OD(OSP)-102 Ethical Issues in Health Disparities and Access to Participation in Research.
Research is needed to assess the under-representation in biomedical and clinical research of U.S. minority populations, underserved populations, and populations who may be vulnerable to coercion or undue influence, to identify barriers to participation in research and to develop approaches for overcoming them. Additionally, studies are needed to assess the impact and ethical considerations of conducting biomedical and clinical research internationally in resource-limited countries. Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; NIAMS Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
02-OD(OSP)-104 Ethical Issues in the Translation of Genetic Knowledge to Clinical Practice.
Genetics and genomics have great promise for the development of personalized medicine, yet the ethical, legal and social implications of both the research and application of genetic and genomic knowledge and technology are far reaching. Studies are needed to better understand the factors that influence the translation of genetic information to improved human health and the associated ethical issues. Examples of studies include those to address ethical issues related to broad sharing and use of new genetic information and technologies for research to improve human health, human subjects protection in genetic and genomic research, the identifiability of genetic/genomic information and how our understanding of identifiability is evolving, return of research results and incidental findings to subjects, alternative models of informed consent for broad data sharing for research, and the impact of intellectual property (IP) issues on development of new technologies. OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(03) Biomarker Discovery and Validation
03-AR-101 Biomarkers Of Persistent Damage After Acute Joint Injury.
Define early biochemical and structural changes that arise after joint injury, such as trauma or anterior cruciate ligament (ACL) tears, which would serve as indicators that could be analyzed in subsequent longitudinal studies to seek biomarkers for progression to early osteoarthritis (OA). These could be used for both preventive intervention, and as preliminary indications for pathways of disease pathogenesis to guide therapeutic development. Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
03-AR-102 Develop Novel Imaging, Proteomic, Or Genomic Approaches To Identify Risk For Fragility Fractures.
Projects may use existing data sets to define and validate measures of bone quality that are more predictive than bone mineral density measurements. Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
03-AR-103 Biomarkers: Bench to Bedside for Autoimmune and Inflammatory Skin and Rheumatic Diseases.
Define biomarkers in autoimmune disease for early diagnosis, use as predictors of clinical outcome, and as surrogates of clinical response. Create the resources required to move promising biomarkers from the bench to the clinic using state of the art statistical, analytical, and computational methods. These include development of new technologies to identify markers of disease onset and clinical response measured by changes in blood or bodily fluids, genetic biomarkers, or by in vivo imaging of cells and tissues. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
03-AR-104 Imaging Biomarkers.
Apply existing and newly developed imaging technologies to improve understanding of musculoskeletal or skin disease, and to enable identification of possible imaging biomarkers associated with disease onset and progression. Broad, innovative use of imaging techniques could enable early identification of disease onset, predict disease progression, and make possible direct monitoring of responses to therapeutic interventions. Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
03-AT-101 Psychoneuroimmunology biomarkers of stress.
Identification of biomarkers to assess the impact of stress, both social and biological, on immune function. Contact: John Glowa, Ph.D., 301-496-0527, glowaj@mail.nih.gov; NIAMS Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
03-OD(ORDR)-101 Validating biomarkers for functional outcomes in rare diseases.
This initiative will provide a program of an expert consultative group to work with research investigators in the design to validate biomarkers and collect the data necessary to relate the biomarker with functional outcome in rare diseases. This program will be designed to stimulate development of new treatment trials. Contact: Dr. Rashmi Gopal-Srivastava, 301-402-4336, gopalr@mail.nih.gov; NIAMS Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(04) Clinical Research
04-AR-101 Autoimmunity For Diseases Of The Skin, Joints, Muscle And Other Tissues.
Develop reagents and analytic methods to identify, characterize, track, and inhibit human B and T cells specific for defined self-antigens, and antigen-presenting cells in diseases of the skin, joints, and other tissues. Define mechanisms by which autoreactive lymphocytes contribute to tissue damage. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
04-AR-102 Clinical Research in Rheumatic, Muscle and Skin Diseases of Childhood.
Studies suggest that children with chronic life-threatening diseases who are treated under a clinical protocol have significantly reduced mortality and morbidity. This also enhances and accelerates understanding of disease and testing of new therapies. The goal is to establish a coordinating mechanism and database software for a pediatric rheumatology consortium, with the goal of having every child with a rheumatic disease entered into a clinical study. Development of consortia for studying children with muscular dystrophies and for rare skin or bone diseases may also facilitate and accelerate research in patients with these diseases. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
04-AR-103 Targets for Intervention in Chronic Pain in Musculoskeletal, Skin and Rheumatic Diseases.
There is significant variability in the amount of pain individuals experience in spite of having the same degree of the tissue injury and destruction due to chronic disease. Complete pain relief is not always achieved even after the replacement of the injured organ, such as in joint replacement. This indicates that many mechanisms in addition to organ damage affect the duration, intensity, and emotional response to pain. The goal is to establish collaborative approaches and private-public partnerships to discover key genetic, biochemical and cellular pathways and processes that can be targeted for intervention to provide long-term pain relief in patients with chronic rheumatic and musculoskeletal diseases. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
04-AR-104 Standardized Use of Patient Reported Outcomes (PRO) for Pain Assessment in Arthritis and Musculoskeletal Diseases Outcomes Studies.
Disease and treatment impact on patients are best evaluated by PROs, which are better overall predictors of long-term morbidity and mortality than many clinical and laboratory tests. The objective is to systematically validate pain PROs developed through the NIH Roadmap PROMIS initiative (http://nihroadmap.nih.gov) in clinical trials and observational studies of chronic diseases of interest to the NIAMS. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
04-AR-105 Critical, Ready To Be Deployed Clinical Research Infrastructure.
Investigators are encouraged to propose, implement and utilize research infrastructure that will accelerate progress and make efficient use of current investments in research. The objectives are to develop shared core resources including state-of-the-art new technologies and instrumentation and to expand and intensify research collaborations and communication between disease-focused research centers, medical research centers and patient care communities. Existing registries and repositories of autoimmune and rare genetic diseases of bone, muscle, skin and connective tissue require new networking systems for linking them to laboratories, research clinics and other national datasets to accelerate genetic research and early validation of biomarkers. Contact: Dr. Joan McGowan, 301-594-5055 NIAMShelp-NIHChallengeGrants@mail.nih.gov
04-AR-106 Cellular, Molecular and Genetic Therapies for Rare Inherited Diseases of Muscle, Skin and Connective Tissue and Bone.
These novel therapeutic approaches offer the possibility of restoring function to a defective gene or compensating for the loss of gene function. These approaches are potentially quite powerful and could lead to significant advances in the treatment of diseases of muscle and other tissues. The goal of the projects will be to find creative approaches to overcome some of the current technical obstacles and resolve remaining ethical issues. Areas of interest include promising vectors, therapeutic genes, local and systemic delivery methods for viral gene therapy; study the immune reaction to gene therapy approaches, methods to improve long-term expression, methods for editing gene products in vivo, such as exon-skipping antisense oligonucleotides and small RNAs. Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
04-GM-101 Personalized drug response and toxicity.
Application of pharmacogenetics and pharmacogenomics, quantitative and systems pharmacology (this could be part of a larger grouping to include systems biology and systems genetics), ADMET pharmacology, preclinical models, and new technologies and approaches to complement pharmacogenomic studies to enhance signal-to-noise ratios and aid mechanistic studies, and consensus standards for normal and altered phenotypes in drug response and toxicity. Contact: Dr. Rochelle Long, 301-594-3827, longr@nigms.nih.gov; Dr. Richard Okita, 301-594-3827, okitar@nigms.nih.gov ; NIAMS Contact: Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
04-AG-101 Therapeutic algorithms for older patients with multiple conditions: data analyses and pilot testing.
Analysis of existing medical record data sets (e.g., from the VA or HMOs) to identify problems associated with the combination of therapies for two or more specific conditions in older patients with multiple conditions. This information could be used to develop new therapeutic algorithms or refine existing algorithms to address problems related to the use of multiple algorithms in older clinically complex patients and to inform short-term intervention studies to assess their efficacy and practicality. Contact: Dr. Susan Nayfield, 301-496-6949, nayfiels@mail.nih.gov; NIAMS Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
04-AA-101 Medication Development for Hepatic Fibrosis.
Alcohol and infectious disease induced hepatic fibrosis affects millions of patients worldwide and remains an unresolved challenge for clinicians. Given the morbidity/mortality associated with this disease, there is an urgent need for translation of emerging antifibrotic molecules into effective therapies. Expediting clinical trials for compounds that have successfully undergone preclinical studies has the potential to make much needed medications available and reduce the need for liver transplantation. Contact: Dr. Samir Zakhari, 301-443-0799, szakhari@mail.nih.gov; NIAMS Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(05) Comparative Effectiveness Research
05-AR-101 Comparative Effectiveness (CE) of Biologics in Autoimmune Rheumatic and Skin Diseases.
Create a research structure to study clinical and cost-effectiveness of biologics to determine the best therapy for individual patients. Disease- and treatment-specific methodologies could include: systematic review of existing research; analysis of effectiveness from large dateset, construction of medical registries for clinical and laboratory data related to efficacy, safety, and health care utilization rates data to evaluate cost-effectiveness; and computer-based modeling of clinical trials to predict the efficacy, safety and cost effectiveness. Contact: Dr. Susana Serrate-Sztein, 301.594.5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
05-AR-102 Comparative Effectiveness (CE) of Treatments for Chronic Childhood Arthritis and Musculoskeletal (MSK) and Skin Disease.
Create a research structure to study clinical and cost-effectiveness of pediatric rheumatic and MSK disease treatments. A number of resources exist to support the rapid implementation of this project, including networks of physicians and researchers (The Childhood Arthritis and Rheumatology Research Alliance; Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers) that have already developed preliminary protocols to evaluate efficacy, effectiveness, and safety of pediatric therapies for specific disease. Examples of CE studies utilizing these approaches could include a registry of all children receiving biologic therapy for JIA, to evaluate comparative clinical and cost-effectiveness, and long-term safety; A randomized, controlled trial to evaluate the efficacy and cost effectiveness of laser surgery and other non surgical approaches in the treatment of infantile hemangiomas;.CE of agents that target interleukin 1 pathways in NOMID; CE of steroid therapies and steroid administration regimens in children with DMD. Contact: Dr. Susana Serrate-Sztein, 301.594.5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
05-AR-103 Comparative Effectiveness of Therapies to Treat Fibromyalgia.
Several drugs have been approved to treat fibromyalgia, a chronic musculoskeletal pain condition. Chronic pain, and its adverse impact on patient functioning and quality of life, will become even more of an economic and societal burden in the United States as the population ages. The purpose of this proposal is to compare recently approved drugs with differing mechanisms of action, i.e., serotonin and norepinephrine reuptake inhibitors, with tricyclic antidepressants1, and biopsychosocial approaches, such as cognitive behavioral therapy. Contact: Dr. Susana Serrate-Sztein, 301.594.5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(06) Enabling Technologies
06-AR-101 Advanced Soft Tissue Imaging of Skin, Muscle, Tendons, Ligaments and Joint Tissues.
Advances in imaging approaches such as magnetic resonance and ultrasound are needed to improve detection and diagnosis, and to monitor regeneration of muscles and tendons damaged due to traumatic or repetitive strain injuries, acquired or inherited diseases. Emerging technologies offer opportunities for exploratory and more focused clinical research on imaging of soft tissues in rheumatic disease, including pre-diagnostic, and wound healing e.g., functional studies and non-invasive imaging to evaluate disease progression and response to treatment. Challenge grants offer support for studies to develop novel imaging techniques, standards and baseline data sets, approaches to integrate imaging data with other functional and physiological outcome measures. There is also interest on pilot studies of natural history of diseases and disorders of muscles and tendons, and on pilot studies on the use of soft tissue involvement for the evaluation of disease activity and clinical response in patients rheumatic and skin diseases. Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
06-AR-102 Systems Biology for Musculoskeletal System Development, Function and Diseases.
Methodology is needed for integrated analysis of disease mechanisms in humans, combining GWAS, gene expression, microRNA, epigenetics studies, immunologic profiles and disease phenotype using existing databases. The goal is a better understanding of the regulatory networks involved in maintaining normal musculoskeletal tissues structure and function and the changes in these networks that correlate with musculoskeletal disease. Studies of gene expression, protein-DNA, protein-RNA, and protein-protein, interactions and of regulatory micro-RNA have generated enormous amounts of relationship data (i.e., who controls whom). These data are being systematically curated to create computable databases by academic and commercial enterprises (e.g., Ingenuity Pathway Analysis software). This effort will eventually lead to the construction of a regulatory map. It is foreseeable that a map of the regulatory networks will provide a powerful tool for understanding all disease processes and for providing a guide for designing more effective therapies. Components include 1) Identify cohorts with valuable clinical and phenotypic data, cell and tissue samples, and existing data sets; 2) Address issues of consent for acquisition and use of resources, including post-mortem; 3) Address issues of data sharing; 4) Establish infrastructure and governance for widely accessible resource of data and analysis tools. Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
06-AR-103 Systems Biology for Skin and Rheumatic Diseases.
Expansion of Merck's proposed Integrative Bionetwork Community to include skin biology and diseases and rheumatic diseases. Merck has proposed to make their database of phenotypic data and genetics available to the public. While it is not clear what this database currently contains, in the area of skin biology/diseases and rheumatic diseases, there are already efforts by several NIAMS-supported research groups to identify the genetic basis of several diseases (e.g. psoriasis, vitiligo, and alopecia areata) through GWAS and to link expression data with the genetics. Similar efforts are ongoing in rheumatic diseases. It would be useful to extend the dataset by the addition of genome-wide epigenetics data and a catalogue of microRNAs identified by high throughput sequencing technologies. The data could also be extended through the addition of more diseases as well as the effects of treatment. There may also be some benefit to include stages of skin development and epidermal differentiation. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
06-DK-101 Development of cell-specific delivery systems for therapy and imaging.
Develop non-viral strategies for cell-specific delivery of pathway-interactors and molecular probes. These new molecular complexes could allow delivery of cell-penetrating agents for the study of disease pathways, the imaging of tissue mass and disease progression, or the development of tissue-specific therapeutics. Contact: Dr. Olivier Blondel, 301-451-7334, blondelol@mail.nih.gov; Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
06-OD(OBSSR)-101 Using new technologies to improve adherence.
New and innovative technologies to improve patient adherence to prescribed medical regimens and utilization of adherence-enhancing strategies in clinical practice would greatly enhance the health impact of efficacious treatments and preventive regimens. This challenge invites the development of new technologies to change patient and provider behaviors to improve adherence. OBSSR contact: Lynn Bosco, 301-451-4286, boscol@od.nih.gov; NIAMS Contact: Dr.Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(07) Enhancing Clinical Trials
07-AR-101 Modeling Clinical Trials in Rheumatic, Skin and Musculoskeletal Diseases.
Promote the development of computer models to assess the influence of prevention and treatment strategies on outcomes and cost effectiveness in common chronic diseases (e.g., osteoarthritis, psoriasis, rheumatoid arthritis and osteoporosis). Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
07-AR-102 Expanding the Use of Alternative Trial Design in Clinical Trials of Rare Diseases of Connective Tissue, Muscle, Skin and Bone.
Owing to the unique nature and limited availability of patients with rare diseases, large traditional clinical trials are often not possible. The objective is to propose novel trial designs that not only capture the scientific and statistical rigor necessary to draw meaningful conclusions from the trial once complete, but are able to accommodate and adapt as necessary to the challenges posed by the study of patients with these diseases. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
07-AR-103 Expand The Involvement Of Clinical Practice Physicians In Community Settings, In Large-Scale Trials in Chronic Musculoskeletal and Skin Diseases.
Efficacy and Effectiveness studies in common chronic diseases often require a large number of patients that are not always followed at large clinical centers. Rare diseases are often hampered by the difficulty in recruiting patients in a timely and cost effective way. The objective is to develop mechanisms that facilitate and accelerate the integration of clinical practices in the organization and implementation of clinical and community based interventions and prevention programs. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
07-AR-104 Develop Central IRB Approval Processes For Existing Clinical Research Networks.
An IRB managed by one institution which reviews all multicenter trials conducted by a collaborating network could potentially provide a higher standard of review with greater efficiency and shorter turn around times. This can potentially decrease trial costs and duration significantly. The goal is to develop stringent but dynamic Central IRB policies and procedures and standardize their deployment for clinical studies in chronic skin, rheumatic and musculoskeletal diseases conducted by established networks. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
07-OD(OBSSR)-101 Improving and/or assessing external validity in randomized clinical trials (RCTs).
The practice of conducting RCTs with volunteer samples recruited from patients in clinical or community settings limits the generalizability of results, a critical problem for comparative effectiveness research. Research is needed to develop scientific tools for improving and/or assessing the external validity of RCT results to known populations, including methods for applying probability sampling in the identification and recruitment of RCT participants, measuring biases in RCT participant pools, and accounting for such biases in the analysis of RCT results. OBSSR contact: Dr. Ronald Abeles, 301-496-7859, abelesr@od.nih.gov; NIAMS Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
07-OD(ORD)-102 Rare disease genetic patient registry.
Support for an efficient infrastructure and expert staff in developing a registry capable of asking for rare-disease-specific information and capturing genetic results across any number of rare diseases, thereby ensuring patients are identified for trials as treatments become available. Contact: Dr. Rashmi Gopal-Srivastava, 301-402-4336, gopalr@mail.nih.gov; NIAMS Contact: Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(08) Genomics
08-AR-101 Genotyping of Existing Cohorts in Rheumatic, Skin, and Musculoskeletal Diseases.
These studies will utilize existing clinical cohorts to add to the broadly shared data resources available to genetic researchers. The immediate result of the work will be the submission of large genotype-phenotype datasets to the database of Genotypes and Phenotypes (dbGaP) (http://www.ncbi.nlm.nih.gov/sites/entrez?db=gap). This is expected to allow the submitting investigators and others to pursue analytical projects that will identify genetic loci contributing to disease risk. The datasets will also provide a testing ground for new methodological approaches for the identification of genetic risk factors. Medical sequencing and replications studies are included, but recruitment of new cohorts is not. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
08-AR-102 Gene Environment Interactions in Autoimmune Disease.
Explore the contribution and mechanisms mediating the contribution of gene-environment interactions in autoimmune disease onset and progression. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
08-NR-101 Genetic and Epigenetic Predictors of Symptom Severity
This initiative will support research on the genetic underpinnings of symptom severity. The findings from this research will identify individuals at greatest risk for symptoms from both acute and chronic conditions and design individualized interventions that will maximize symptom management. Contact: Dr. Joan Wasserman, 301-594-5971, wassermanje@mail.nih.gov; NIAMS Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(09) Health Disparities
09-AR-101 Define The Biologic Mechanisms Underlying Increased Susceptibility To And Severity Of Lupus Among Ethnic Groups.
People of all races can have lupus; however, African American women have a three times higher incidence (number of new cases) and mortality than white women, develop the disease at a younger age and have more serious complications. Lupus it is also more common in women of Hispanic, Asian, and Native American descent. The goals are to define the biologic mechanisms underlying increased susceptibility to and severity of lupus among ethnic groups, foster research to identify strategies to reduce health disparities in lupus patient populations, promote research on the relationships between socioeconomic status factors and disease outcomes (i.e. self-efficacy, literacy, patient preferences, access,), and explore new strategies that improve participation of disproportionately affected lupus groups in patient-oriented research. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
09-AR-102 Prevention Strategies that Target Disproportionately Affected Lupus and Scleroderma Patient Populations.
Basic and epidemiologic research provides the knowledge base to design effective strategies for biologic prevention of disease onset. The goal is to develop reagents and methods to identify populations at risk for disease onset and organ-specific clinical manifestations. This includes the development of new technologies, such as chip technology to identify populations at risk, diagnose disease, assess tissue damage and monitor responses to therapy. Chip technology allows for high-density, comprehensive gene expression analysis, and for measuring the expression of thousands of genes at a time, producing a very detailed picture of how one cell differs from other cells. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
09-AR-103 Reduce Racial Disparities In Total Joint Replacement.
Total joint replacement is a successful procedure for end-stage arthritis of the major weight-bearing joints. More than 500,000 hip and knee replacements are done annually in the United States. For reasons that are not fully understood, more of these procedures are performed in whites than in African Americans. Observed differences in the rate of total hip replacement by race may reflect a disparity in access, referral for care, or patient knowledge and preferences for African Americans. The focus is on new refined methods to further analyze the underlying reasons for the disparate ratio of total joint replacement utilization. In this way, the benefits of total joint replacement can be extended to a segment of the population that may benefit, but appears to have limited utilization. Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
09-AR-104 Understanding Vitiligo.
Vitiligo is a disease of the skin characterized by a loss of pigment in all people who are affected. The psychological and social consequences are particularly profound in people of color who are affected. The goal is to discover the genes that cause vitiligo and once the gene(s) are identified characterize the gene defects, protein abnormalities, and determine how these changes result in the disease itself. Utilize this information to design predictive, diagnostic and treatment approaches. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
09-AR-105 Keloids.
Keloids are an abnormal exuberant form of wound healing in which excessive connective tissue is laid down at the wound site, and is not remodeled normally (as distinguished from hypertrophic scars in which there is excess connective tissue initially, but remodeling takes place over time). Keloids are seen predominantly in African American individuals. The goals are to identify the gene(s) for keloid formation and how these abnormalities produce disease and the use this information to design predictive, diagnostic, and treatment strategies. The focus is also on studies of collagen deposition and remodeling, fibroblast growth and metabolism and its control and on new experimental model systems for keloids to evaluate potential new therapies. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
09-MD-102 Trans-disciplinary Research to Integrate the Biological and Non-biological Determinants of Health to Address Health Disparities.
Research interests include trans-disciplinary approaches to address health disparities through collaborative efforts and sustained partnerships with social scientists, policy researchers, health researchers, environmental scientists, and behavioral scientists, for example. Strategies that develop community infrastructure and networks, including non-traditional partnerships are also of interest. NCMHD Contact: Dr. Nathaniel Stinson, 301-402-1366, stinsonn@mail.nih.gov; NIAMS Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(10) Information Technology for Processing Health Care Data
10-OD-101 Adapt existing genetic and clinical databases to make them interoperable for pharmacogenomics studies.
In order for personalized approaches to drug therapy to be developed, genetic data and clinical data need to be superimposed. Analysis of the superimposed data will generate hypotheses concerning genetic control of drug efficacy. NIDA Contact: Joni Rutter, 301-435-0298, jrutter@mail.nih.gov; NIAMS Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
10-LM-101 Informatics for post-marketing surveillance.
Use computational data mining (artificial intelligence and natural language processing, among other techniques) of a large longitudinal medical records database to perform post-marketing surveillance (Phase 4 Clinical Trial). Large clinical data repositories exist that contain longitudinal health records for millions of people. Advanced computational techniques can be used to mine clinical notes, test data and abnormal images to undertake an in silico Phase 4 Clinical Trial, by searching for possible adverse drug events and side effects of drugs already in use. Contact: Dr. Milton Corn, 301-496-4621, cornm@mail.nih.gov; NIAMS Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(11)Regenerative Medicine
11-AR-101 Musculoskeletal And Skin Tissue Regeneration.
Define the molecular pathways that regulate the integration of muscle, tendon, and bone into functional units. Develop applicable animal models for regeneration of musculoskeletal or skin tissues. Define outcome measures, such as non-invasive analysis of disease, injury, and repair. Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
11-AR-102 Basic Studies on Regenerative Medicine/Tissue Engineering and Wound Repair.
The objectives are to define differences in molecular pathways in healing versus non-healing wounds, in acute versus chronic tissue (skin, joint) damage, and in the pathways that regulate the integration of muscle, tendon and bone into functional units. NIAMS Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(12) Science, Technology, Engineering and Mathematics Education (STEM)
For this RFA, there is no NIAMS-specific Challenge Topic in this Challenge Area.
(13) Smart Biomaterials — Theranostics
13-AR-101 Biomaterials for Wound Healing.
The inability of chronic wounds to heal is a major health problem in the United States, and the problem will increase in magnitude as the population ages. Understanding and controlling the regenerative process is essential; the natural wound healing response is "over-exuberant" and can create additional morbidity in the form of hypertrophic scarring and fibrosis. There is tremendous interest in developing methods to attract endogenous cells to the wound site to mediate the healing processes; to conduct exploratory work to evaluate new scaffolds and biomaterials that may allow identification of cell populations migrating to the wound edge, and enhance homing and residency of endogenous cells. Other studies of interest include investigation of materials to deliver cells, growth factors, cytokines, or other agents and the use functional bonds to regulate release of these factors. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
13-EB-101 Theranostics: Combined delivery of diagnostic and therapeutic agents.
Development of novel approaches to deliver combined diagnostic and therapeutic agents to appropriate sites with high specificity and in adequate concentrations to realize the promise of combined diagnosis and treatment of diseases in a single sitting ("theranostics"). NIBIB Contacts: Dr. Lori Henderson, 301-451-4778, hendersonlori@mail.nih.gov; William Heetderks, 301-451-4772, heetderw@mail.nih.gov; NIAMS Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(14) Stem Cells
14-AR-101 Delineate Factors That Control The Differentiation Of Pluripotent Stem Cells In The Skin And Musculoskeletal System Into Different Lineages.
Define the cells' phenotypes as they differentiate along these pathways. Develop a common vocabulary for stem cell differentiation. NIAMS Contact: Dr. Susana Serrate-Sztein 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
14-AR-102 Discovery Technologies for Multipotent and Induced Pluripotent Stem Cells from Human Skin and Musculoskeletal Tissues.
Manipulation of stem cells offers exciting opportunities to understand disease and indentify new effective therapies. Identify and characterize multipotent stem cell populations in adult tissues of the skin and musculoskeletal system and develop methods for isolation of these cells. Develop more efficient methods to generate induced pluripotent stem cells from skin cells without the risk of future malignancy due to integration of viral vectors. Delineate factors that control the differentiation of these multipotent and induced pluripotent stem cells into different lineages. Define the cells' phenotypes as they differentiate along these pathways. Develop a common vocabulary for stem cell differentiation. NIAMS Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
14-DK-101 Induced pluripotent stem cells--cellular and humanized mouse models of disease.
Somatic cells, such as fibroblasts, from patients with diseases can be used to create cell lines, tissues and, perhaps, organ systems, through induced Pluripotent Stem Cell (iPSC) technology. Such models could be used to elucidate underlying pathology of disease or screen for agents that could be used therapeutically. Combining this approach with mouse strains able to accept multiple human tissues without rejection could provide the microenvironmental milieu to support the tissue's physiological function within the context of the whole organism, enabling greater understanding of disease pathogenesis and providing a platform for preclinical testing of drug candidates. NIDDK Contact: Dr. Dan Wright, 301-594-7717, wrightdan@mail.nih.gov; NIAMS Contact: Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
(15) Translational Science
15-AR-101 Interrelationships Between The Immune Response And Regulatory And Structural Components Of Synovium, Cartilage, Bone And Muscle In Health And Disease.
The objective is to promote multi and interdisciplinary research teams and projects that will effectively and swiftly integrate the study of immune mechanisms in the investigation of pathogenesis of chronic musculoskeletal, skin and muscle diseases. Recent work indicates that bone and possibly skeletal muscle and the immune system share some of a complex network of cytokines and molecular mediators that regulate function and homeostasis. Better understanding in normal and pathological situations of interactions between the immune system and bone, muscle, skin and joint tissue will lay the groundwork for future therapies for diseases within the NIAMS mission. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
15-AR-102 Link Genomics, Proteomics, Bioinformatics, And Systems Biology To Clinically Relevant Outcomes in Autoimmune Diseases.
The objective is to develop new, cost effective and accurate tools that will be used to predict, prevent and monitor autoimmune diseases. Define assays that are effective at monitoring disease activity and that predict the development of specific complications. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
15-AR-103 Joint Structures, Alignment, and Gait.
The development of appropriate therapies and biomarkers for arthritis requires a clear understanding of the risk factors and structural components that are associated with well-phenotyped disease. The goal is to develop collaborative research teams that include bioengineers, kinesiologists, rheumatologists, orthopaedic surgeons, physiatrists and imagers to improve our understanding of the interactions between joint structures, alignment, and gait. Such collaborations could lead to the development of multidisciplinary and multi-systems approaches to treatment and prevention of disease. Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
15-AR-104 Bone and the Nervous System.
Nerves thread throughout bones, carrying chemical and electrical messages to and from the brain. Evidence has begun to accumulate suggesting that the nervous system can have significant influence on the balance between bone formation and bone resorption. Understanding this communication between bone and nervous system could lead to new therapies to prevent or reverse bone loss. It could also reveal previously unrecognized side effects of drugs already in wide use for the treatment of high blood pressure, seizures, and depression. Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
15-AR-105 Bone And Adipose Tissue.
Recent advances have shown that bone metabolism is closely linked to regulation of energy metabolism, and is sensitive to signals originating in adipose tissue, the digestive system, and the central nervous system. The unanticipated consequences of certain drugs may occur because their targets often have functional roles in several different tissues, and signals can arise in one tissue and act in another. For example, some drugs that are widely used to control diabetes may have deleterious effects on bone. Targeting specific molecules and biochemical pathways that mediate the interactions between bone and adipose tissue will be critical to develop therapies that improve both bone health and energy metabolism. Contact: Dr. Joan McGowan, 301-594-5055, NIAMShelp-NIHChallengeGrants@mail.nih.gov
15-AR-106 Transdermal Drug Delivery.
Transdermal delivery of drugs for local and systemic therapy have several advantages over oral and IV administration and hypodermic injection, including improved bioavailability, prolonged release, increased patient compliance, cost, and the avoidance of needles.. There is a need to improve our understanding of the skin barrier function and identify molecules and processes that could be targeted to affect skin permeability. Transdermal delivery could be extended to hydrophilic small molecules and macromolecules such as peptides, monoclonal antibodies, siRNAs and nanoparticles. In addition, vaccines delivered to skin may generate a stronger immune response through the targeting of epidermal Langerhans' cells and dermal dendritic cells. Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
15-DE-102 New Models and Measures in Pre-clinical Chronic Pain Research.
Existing animal models of temporomandibular or orofacial pain conditions inadequately reflect the pathology or the phenotypes of the human state. Goal: Development of new animal models to study the transition from acute to chronic pain in temporomandibular joint disorders or other orofacial pain disorders. Coupled with the development of new functional and behavioral assays of acute and chronic pain, these animal models would be a powerful means to enhance our understanding of the biological mechanisms underlying the development of these chronic pain conditions and the responses of patients to therapeutic interventions. NIDCR Contact: Dr. John Kusiak, 301-594-7984, John.Kusiak@nih.gov; NIAMS Contact: Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
15-TW-101 Models to predict health effects of climate change.
Quantitative and predictive models of effects of climate change on disease burden and health outcomes are needed. Approaches may include statistical, spatial or other modeling methods to quantify the current impacts of climate on a diversity of communicable or non-communicable diseases, or project impacts of different climate and socio-economic scenarios on health. For example, new and innovative approaches to develop projections of changes in disease burden in specific regions or populations will facilitate public health planning. Existing databases on population and environmental variables, such as air quality and climatologic episodes should be used to test the utility of these models where possible. FIC Contact: Dr. Joshua Rosenthal, 301-496-1653, joshua_rosenthal@nih.gov; NIAMS Contact: Dr. Susana Serrate-Sztein, 301-594-5032, NIAMShelp-NIHChallengeGrants@mail.nih.gov
For general information on NIAMS implementation of NIH Challenge Grants, contact:
Robert H. Carter, MD
Deputy Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
NIAMShelp-NIHChallengeGrants@mail.nih.gov
For Financial or Grants Management questions, contact:
Andrew Jones
Acting Chief Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
301-435-0610
jonesan@mail.nih.gov
