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High-Priority Areas for Research Leveraging EHR and Large-Scale Data (R01 Clinical Trial Not Allowed)
Funding Opportunity Purpose
This Funding Opportunity Announcement (FOA) encourages research project grant (R01) applications to leverage large-scale, real-world data from electronic health records (EHRs) from a variety of systems (e.g., the Department of Defense (DOD), Department of Veterans Affairs (VA), Centers for Medicare and Medicaid Services administrative claims, as well as public or private health care systems and networks) to understand risk, onset, course, and impact of treatments and services for mental and neurological disorders and to identify promising new mental health and neurological disorders research. There is particular interest in leveraging EHRs and administrative data to 1) understand and improve the treatment of post traumatic psychopathology, including posttraumatic stress disorder, depression, traumatic brain injury (TBI), and risk for suicide; and 2) characterize post-trauma multi-symptom recovery trajectory patterns of TBI, that may include post traumatic stress disorder, depression, cognitive impairment, pain, substance abuse disorder and risk for suicide. NIMH also invites innovative approaches to use EHR and administrative data to understand risk, onset, course, and impact of treatments and services for mental disorders more broadly.
Analytical and/or Clinical Validation of a Candidate Biomarker for Pain (R61/R33 Clinical Trial Optional)
Funding Opportunity Purpose
The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the validation of strong candidate biomarkers and endpoints for pain that can be used to facilitate the development of non-opioid pain therapeutics from discovery through Phase II clinical trials. Specifically, the focus of this FOA is on advanced analytical and clinical validation of pain biomarkers, biomarker signatures, and/or endpoints using retrospective and/or prospective methods. It is assumed that: 1) a candidate biomarker has already been identified, 2) assay technology has already been developed, and 3) a working hypothesis regarding Context of Use is in place. Research supported by this FOA will ultimately demonstrate that biomarker or endpoint change is reliably correlated with variables such as clinical outcome, pathophysiologic subsets of pain, therapeutic target engagement or response to a pain therapeutic; in addition, biomarker response will demonstrate specificity to the pain condition or therapeutic as demonstrated at multiple clinical sites. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers, biomarker signatures and endpoints of pain to application in clinical trials (Phase II clinical trials and beyond) and in the spectrum of clinical practice.
Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)
Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery and validation of novel therapeutic targets to facilitate the development of pain therapeutics. Specifically, the focus of this FOA is on the basic science discovery of targets in the peripheral nervous system, central nervous system, immune system or other tissues in the body that can be used to develop treatments that have minimal side effects and little to no abuse/addiction liability. Research supported by this FOA must include rigorous validation studies to demonstrate the robustness of the target as a pain treatment target. This will lower the risk of adopting the target in translational projects to develop small molecules, biologics, natural substances, or devices that interact with this target for new pain treatments. Translational research to develop new medical devices are not the focus of this FOA. Basic science studies of pain and related systems in the body are responsive to this FOA and are encouraged in the context of novel pain therapeutic target discovery. This FOA is not specific for any one or group of pain conditions. Projects to identify novel targets for acute pain, chronic pain, migraine, other headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, sickle-cell pain, post stroke pain, etc. will be considered. Projects to identify novel targets for a combination of chronic overlapping pain conditions or for specific pathological conditions will be considered. Projects that seek to identify novel targets in specific populations such as women, children, older adults or other underrepresented groups will also be responsive to this FOA.
Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R21 Clinical Trial Not Allowed)
Funding Opportunity Purpose
This R21 NIH Exploratory/Developmental Grant supports exploratory and developmental research projects by providing support for the early and conceptual stages of pain target discovery and validation projects. These studies may involve considerable risk but may lead to a breakthrough in a pain treatment.
NIH Blueprint Program for Enhancing Neuroscience Diversity through Undergraduate Research Education Experiences (R25)
Funding Opportunity Purpose
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NIH Blueprint R25 program is to support educational activities thatenhance the diversity of the biomedical, behavioral and clinical research workforce. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on Courses for Skills Development, Research Experiences, and Mentoring Activities. The fully integrated educational activities should prepare undergraduate students from diverse backgrounds nationally underrepresented in biomedical and behavioral sciences to enter Ph.D. degree programs in the neurosciences. To accomplish this goal, this initiative will provide institutional awards to develop neuroscience research education programs comprised of collaborative partnerships integrated across different educational institution types. Each partnership must include: a) one or more institutions that have substantial enrollment of diverse undergraduates from populations underrepresented in the biomedical and behavioral sciences, b) a research-intensive institution that has an established neuroscience or neuroscience-related program, c) integrated curriculum/academic enhancement and research training activities designed to increase participants' preparation to enter doctoral programs in the neurosciences, and d) well-described plans to provide early communication and interaction between participating students and graduate neuroscience programs across the country.
BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP (U19 Clinical Trial Required)
Funding Opportunity Purpose
This FOA will support integrated, interdisciplinary research teams from prior BRAIN technology and/or integrated approaches teams, and/or new projects from the research community that focus on examining circuit functions related to behavior, using advanced and innovative technologies. The goal will be to support programs with a team science approach that can realize meaningful outcomes within 5-plus years. Awards will be made for 5 years, with a possibility of one competing renewal. Applications should address overarching principles of circuit function in the context of specific neural systems underlying sensation, perception, emotion, motivation, cognition, decision-making, motor control, communication, or homeostasis. Applications should incorporate theory-/model-driven experimental design and should offer predictive models as deliverables. Applications should seek to understand circuits of the central nervous system by systematically controlling stimuli and/or behavior while actively recording and/or manipulating relevant dynamic patterns of neural activity and by measuring the resulting behaviors and/or perceptions. Applications are expected to employ approaches guided by specified theoretical constructs, and are encouraged to employ quantitative, mechanistic models where appropriate. Applications will be required to manage their data and analysis methods in a prototype framework that will be developed and used in the proposed U19 project and exchanged with other U19 awardees for further refinement and development. Model systems, including the possibility of multiple species ranging from invertebrates to humans, can be employed and should be appropriately justified. Budgets should be commensurate with multi-component teams of research expertise including neurobiologists, statisticians, physicists, mathematicians, engineers, computer scientists, and data scientists, as appropriate - that seek to cross boundaries of interdisciplinary collaboration.
BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Clinical Trial Required)
Funding Opportunity Purpose
Invasive surgical procedures provide the unique ability to record and stimulate neurons within precisely localized brain structures in humans. Human studies using invasive technology are often constrained by a limited number of patients and resources available to implement complex experimental protocols and are rarely aggregated in a manner that addresses research questions with appropriate statistical power. Therefore, this RFA seeks applications to assemble diverse, integrated, multi-disciplinary teams that cross boundaries of interdisciplinary collaboration to overcome these fundamental barriers and to investigate high-impact questions in human neuroscience. Projects should maximize opportunities to conduct innovative in vivo neuroscience research made available by direct access to brain recording and stimulating from invasive surgical procedures. Projects should employ approaches guided by specified theoretical constructs and quantitative, mechanistic models where appropriate. Awardees will join a consortium work group, coordinated by the NIH, to identify consensus standards of practice, including neuroethical considerations, to collect and provide data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community.
Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
Funding Opportunity Purpose
The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) hereby notify Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding specific types of research grants (activity codes listed above) that funds are available for administrative supplements to improve the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project. Administrative supplements must support work within the scope of the original project. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.
Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) (D43)(Clinical Trial Optional)
Funding Opportunity Purpose
This funding opportunity announcement (FOA) encourages applications for the Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) D43 program for institutional research training programs in low-and middle-income countries (LMICs, as defined by the World Bank classification system). Applications may be for collaborations between institutions in the U.S and an eligible LMIC or may involve just LMIC institutions if there is a previous track record of externally funded research and/or research training programs by the lead LMIC institution. The proposed institutional research training program is expected to sustainably strengthen the NCD research capacity of the LMIC institutions, and to train in-country experts to develop and conduct research on NCDs across the lifespan, with the long-range goal of developing and implementing evidence-based interventions relevant to their countries. The main focus of research training covered in the application must be relevant to the interests of at least one of the participating NIH ICs as stated by each in this FOA. Other NCD topics may be included as secondary and complementary focus areas.
Clinical Trial on Effects of Statins in Older Adults without Clinical Cardiovascular Disease (U19 Clinical Trial Required)
Funding Opportunity Purpose
NIA and NHLBI invite applications for a seven-year pragmatic trial from a network or consortium of health care delivery systems (HCS) which together cover most of the geographic regions of the United States and a data coordinating center to assess the overall risks and benefits of stains in adults 75 years of age and older without clinical cardiovascular disease.