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Native American Research Center for Health (NARCH)
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Research Initiative
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IHS
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NIGMS, CSR, NCI, NIA, NIAAA, NIAID, NIAMS, NICHD, NIDA, NIDCR, NIDDK, NIEHS, NIMH, NIMHD, OD/DPCPSI/OBSSR, OD/DPCPSI/ORWH
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The Native American Research for Health (NARCH) program is a trans-NIH collaboration with the Indian Health Service (IHS) that supports collaborations between federally-recognized American Indian/Alaska Native (AI/AN) Tribes or Tribal organizations and research-intensive academic institutions that support health research projects prioritized by the Tribal communities. NARCH supports competitive research linked to the health priorities of AI/AN organizations and health disparities; increasing the capacity of both AI/AN organizations and research-intensive institutions to reduce distrust by AI/AN communities and people toward research; and developing a cadre of AI/AN scientists and health professionals engaged in biomedical, clinical, behavioral, and health services research who will be competitive in securing the National Institutes of Health (NIH) funding.
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Natural Compounds to Reduce Nitrate in Meat Products: Phytome
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Research Initiative
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CDC
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NCI
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The National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC) are collaborating on a longitudinal human feeding study of processed meats and drinking water nitrate conducted by Maastricht University. CDC researchers are measuring volatile nitrosamines (NOCs) and nitrate concentrations in urine samples taken before and after consumption different types of processed meats with and without the intake of nitrate in drinking water. NCI will also evaluate nitrate and nitrosamine excretion levels in relation to the oral microbiome. Results from this study will characterize NOC formed from water nitrate and processed meat ingestion.
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Natural Experiments and Effectiveness Studies in the Prevention and Control of Diabetes
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Research Initiative
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CDC
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NIDDK
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This project will focus on population-targeted interventions that health systems, communities, and governments can undertake to reduce the incidence of diabetes and its complications. This project will also strengthen the capacity of the Centers for Disease Control and Prevention (CDC) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to conduct vital health services and health policy research related to diabetes prevention and care.
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Natural History of Ebola Virus Zaire (Kikwit-7U) in Cynomolgus Macaques
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Resource Development
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FDA
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NIAID
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The US Army Medical Research Institute of Infectious Diseases (USAMRIID) is conducting a detailed natural history study in the cynomolgus macaque (Macaca fascicularis) model of EBOV Zaire (Kikwit 7U) infection delivered by the intramuscular route. Numerous vaccine studies have been performed using this model, however a detailed natural history study following Good Laboratory Practices regulations is required to satisfy the Food and Drug Administration (FDA) “Animal Rule”.
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NCCOR- National collaborative for childhood obesity research
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Committee, Work group, Advisory group, or Task Force
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CDC
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NHLBI, NCI, NICHD, NIDDK, OD/DPCPSI/OBSSR
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To accelerate progress in reducing childhood obesity in America.
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NCHS-CDC-NHANES, Audiometry, Balance, and Words in Noise Component
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Health Survey
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CDC
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NIDCD
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To provide support to the National Center for Health Statistics (NCHS), CDC for balance/vestibular testing and related questions on balance and dizziness problems in the U.S. population aged 40+ years.in the National Health and Nutrition Examination Survey (NHANES Epidemiology Survey), 2018 (pilot testing) and 2019-2020 (implementation). In addition the Audiometry Component of NHANES 2019-2020 will be augmented with a Word in Noise test administered to older adults, 70+ years of age. The prevalence of balance disorders in the US is high and increases with age. Data from NHANES 2000-2004 epidemiological survey indicate that 35.4% (69 million) US adults aged 40 or older have some balance dysfunction; prevalence jumps to 69% among those aged 70-79 years and 85% among those aged 80+ years. The higher risk of balance impairments among the elderly is due to functional changes associated with aging. The control of balance becomes increasingly dependent on visual and proprioceptive cues as we age, making the elderly more vulnerable to falls when those orientation cues are degraded.
Individuals with balance trouble have a six-fold increase in the risk of falling; fall risk increases even further among individuals who report symptoms of dizziness. Falls are the leading cause of both fatal and nonfatal injuries among older adults (aged 65 years and older). In 2014, approximately 3 million older adults sought treatment in emergency rooms for fall-related injuries; 800,000 of these patients required hospitalization and 27,000 patients died. Direct medical costs of falls in the US in 2000 were more than $19 billion. Many people who fall develop a fear of falling, even if they are not injured. This fear may cause them to limit their activities leading to reduced mobility and loss of physical fitness, which in turn increases their actual risk of falling.
In addition to the elderly, several other groups are at increased risk for balance disorders. Race other than white, lower educational status, diabetes, and hearing loss is associated with poorer balance function. In addition, individuals who have sustained head injuries are likely to suffer from problems with balance and dizziness.
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NCI Clinical Trials and Translational Research Advisory Committee (CTAC)
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Committee, Work group, Advisory group, or Task Force
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CMS, FDA
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NCI
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The Clinical Trials and Translational Research Advisory Committee makes recommendations on the National Cancer Institute-supported national clinical trials enterprise to build a strong scientific infrastructure by bringing together a broadly developed and engaged coalition of stakeholders involved in the clinical trial process. The Committee will provide advice on matters related to the conduct, oversight, and implementation of clinical trials and translational research across the Institute.
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NCI Convenes Workshop on Reproducibility of Fecal Microbiota Transplants in Cancer Therapeutics
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Meeting/ Workshop
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FDA
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NCI, NIAID
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To explore the potential role that fecal microbiota transplants (FMT) and pre/probiotics may play in cancer therapeutics and to address reproducibility and safety to inform translational human studies and clinical trials, National Cancer Institute (NCI) convened a “Strategic Workshop on Rigor and Reproducibility: Precision Fecal Microbiota Transplant and Microbiome Cancer Therapeutics” on September 5, 2019. This timely meeting brought together scientists and Food and Drug Administration (FDA) regulatory staff in the fields of FMT, pre/probiotics, nutrition, microbiome, synthetic biology, biomarkers, computation, immunology, gastroenterology, oncology, and infection.
Workshop Goals
Assess the current state of clinical research and clinical trials involving FMT and microbiome-based cancer therapeutics; Discuss the knowledge gaps and future opportunities in the field; Provide feedback to NCI and National Institutes of Health (NIH) regarding future priority areas to enhance precision- and mechanism-based rigor and reproducibility of defined microbiome-based therapeutic clinical research for cancer and other diseases
Workshop Focus Areas
Standardization (material manufacture and quality control), FMT donor selection, microbiome measurement, clinical protocols, procedures, and trial design; Microbiome composition and function as biomarkers associated with cancer therapy, such as reproducibility, safety, and efficacy; Confounding variables — host genetic and disease state, environment, antibiotics, diet and other lifestyle factors; Clinical efficacy and safety of FMT and microbiome-based cancer therapy; Clinically relevant models and human translational studies; Data sharing; FDA regulatory issues
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NCI/CCR-FDA Clinical Investigator Program
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Research Initiative
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FDA
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NCI
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Multilateral Benefit in a Joint Program to Recruit Combined Food and Drug Administration (FDA) and the National
Cancer Institute''s (NCI) Center for Cancer Research (CCR) Clinical Investigators: the FDA gains an academic oncologist with disease-specific expertise who is actively involved and understands critical nuances of the field; NCI gains a clinical investigator and leader who understands regulatory considerations in drug development; and the oncologic community gains a regulator/academic who will provide a leadership voice to help design trials with regulatory endpoints in mind
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NCI/FDA Memorandum of Understanding for Drug Related Information
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Resource Development
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FDA
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NCI, CC, NHGRI, NHLBI, NIAID, NIDCR, NLM
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The National Cancer Institute (NCI) Enterprise Vocabulary Services is working with the US Food and Drug Administration (FDA) to develop and support controlled terminology in several areas. More than 24,000+ FDA terms and codes are stored in the NCI Thesaurus. NCI Enterprise Vocabulary Services (EVS) provides resources and services to meet NCI, National Institutes of Health (NIH), and other partners; needs for controlled terminology, including the creation, extension, subsetting, mapping, accessing, and publishing of shared standard biomedical terminologies and ontologies. The National Cancer Institute (NCI) is collaborating with other NIH institutes to develop terminology content standards extending across basic, translational and clinical research, clinical care, epidemiology, public health, administration, and public information.
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