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Planning and Design for post-acute care assessment instruments and data elements
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Resource Development
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CMS
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NLM
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The ultimate goal of this work is to improve quality of care and interoperability of computerized data in acute hospitals and post-acute care (PAC) settings through use of health informatics and real-time transfer of patient information. The National Library of Medicine (NLM) and Centers for Medicare & Medicaid Services (CMS) collaborate on planning and design for the Continuity Assessment Record & Evaluation (CARE) instrument and its data elements, and those of other CMS post-acute care assessment tools; develop logical data model and software applications that promote compliance and compatibility with Federal Health Architecture consolidated health informatics (CHI) standards; adopt Federal government-wide health information interoperability standards associated with Meaningful Use; and improve data and messaging for the Medicare program. This collaboration benefits from NLM''s role as central U.S. Department of Health and Human Services (HHS) coordinating body for clinical terminology standards, and provides NLM specific and usage-based feedback on the utility of such standards in this environment.
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Planning Committee for the NIH Consensus Workshop on Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain
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Meeting/ Workshop
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FDA, HRSA
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NCI, NHLBI, NIA, NICHD, NIDCR, NIDDK, NINDS, NINR, OD/DPCPSI/OBSSR, OD/DPCPSI/ODP, OD/DPCPSI/ORWH
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This consensus workshop is designed to determine what data exists or is needed to help improve the clinical treatment of pain with opioids.
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Pluripotent Stem Cells in Translation: Early Decisions
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Meeting/ Workshop
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FDA
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NINDS, NHLBI, NIDCR, OD/DPCPSI
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The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) are organizing a series of workshops that will engage the broader research community regarding requirements necessary for translation of pluripotent stem cell-derived products into the clinic. The first workshop, held March 2011, focused on establishment of stem cell lines and banks, covering safety and regulatory issues related to how the original cell line derivation is done in the case of embryonic stem cells, and how the cells are reprogrammed in the case of Induced pluripotent stem (iPS) cells. The second workshop, held July 10-11, 2012, focused on preclinical safety and proof of concept testing, including, among other topics, clinical relevance of the animal models, selection of cell dose levels, impact of host microenvironment, and cell fate post-administration. A third, and final, workshop is expected to focus on clinical trial design including safety monitoring, immunogenicity, immunosuppressant use and immune monitoring.
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Polyhalogenated aromatic hydrocarbons (PHAH) and thyroid cancer
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Research Initiative
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CDC
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NCI
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Polyhalogenated aromatic hydrocarbons are being measured in banked serum/plasma samples from cohort studies to evaluate the association with thyroid cancer incidence.
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Population Assessment of Tobacco and Health Study
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Health Survey
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FDA
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NIDA
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The Population Assessment of Tobacco and Health (PATH) Study is the first large-scale National Institutes of Health (NIH)/U.S. Food and Drug Administration (FDA) collaboration since Congress granted FDA the authority to regulate tobacco products in the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009. The PATH Study is a national longitudinal cohort study that will follow an estimated 59,000 U.S. household residents ages 12 years and older for at least three years. Objectives are to assess initiation and use patterns; to study trends in tobacco-product use cessation and relapse; to monitor behavioral and health impacts, including in risk perceptions and other tobacco-related attitudes; and to assess differences in tobacco-related attitudes, behaviors, and health outcomes among racial/ethnic, gender, and age subgroups. The PATH Study will also collect biospecimens from adults to analyze biomarkers of tobacco use and related health outcomes. By measuring and accurately reporting on the social, behavioral, and health effects associated with tobacco-product use in the U.S., the PATH Study will provide an empirical evidence base to help inform FDA’s decisions about changes in tobacco products in meeting the objectives of the 2009 FSPTCA.
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Post-traumatic Stress Disorder (PTSD)/Trauma Brain Injury (TBI) Workgroup
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Committee, Work group, Advisory group, or Task Force
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OS
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NIMH, NIAAA, NIDA, NINDS
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A 2012 White House Executive Order, emphasizing support of service members, veterans, and their families as a “top priority,” called for an urgent increase in the U.S. Departments of Health and Human Services (HHS), Defense (DOD), and Veterans Affairs (VA) research coordination to address the problems of Post-traumatic stress disorder (PTSD), Traumatic brain injury (TBI), and suicide. Section 5 of this Executive Order requested a National Research Action Plan to develop biomarkers, define the pathophysiology, and create new treatments for PTSD. HHS charged the National Institute of Mental Health (NIMH) to lead this effort along with a parallel effort for TBI led by the National Institute of Neurological Diseases and Stroke (NINDS), with both Institutes working closely with the VA and DOD. In 2013, the National Research Action Plan was released in response to the Executive Order. Fortunately, prior investments interrogating the molecular, genomic, and circuitry changes that give rise to PTSD in the context of environmental factors provide the requisite foundation to respond to this White House request for biomarkers for risk prediction, as well as new targets for medications and other therapies to treat PTSD. Such an investment has the potential to revolutionize the care for individuals at high risk for PTSD, and prevent the development of chronic complex treatment resistant PTSD.
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Potential of Candidate Cell Substrates for Vaccine Production to Propagate the Agents of Transmissible Spongiform Encephalopathies
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Research Initiative
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FDA
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NIAID
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Accidental contamination represents a major risk associated with the use of cell-substrate derived biologicals, including vaccines and antibodies, for human use. The possibility for viral contamination exists in primary cultures and established cultures. Sometimes these cells are grown in serum containing fetal calf serum, which can develop into transmissible spongiform encephalopathy (TSE/BSE). This initiative aims to rigorously characterize and safety test these cell substrates. For TSE/BSE infectivity, the long incubation time requires testing over multiple years. An external committee recommended testing for at least 10 years to obtain the maximum information.
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Practical Oral Care for People with Developmental Disabilities
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Public Education Campaign
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CDC
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NIDCR, NICHD
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A series of publications designed to equip dental professionals in the community with the information they need to deliver quality oral health care to people with special needs.
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President''s Commission on the Study of Bioethical Issues
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Committee, Work group, Advisory group, or Task Force
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OS
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CC
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Christine Grady participates as a Commissioner on the Presidential Commission for the Study of Bioethical Issues. The Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. The Commission seeks to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner. The Commission undertakes study of issues presented to them by the President and the Secretary of Health and Human Services.
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President’s Emergency Plan for AIDS Relief (PEPFAR) Implementation Science / Combination Prevention
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Research Initiative
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CDC
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NIAID, NIDA
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This President''s Emergency Plan for AIDS Relief (PEPFAR) activity focuses on testing treatment as prevention on the population level in South Africa and Zambia. This activity was initiated through the HIV Prevention Trials Network (HPTN), with support of multiple National Institutes of Health (NIH) Institutes and Centers, PEFPAR, and the Bill & Melinda Gates Foundation. The Requests for Application (RFA) was issued concurrently with a Centers for Disease Control and Prevention (CDC) RFA for combination prevention, and the agencies have worked together to ensure that the studies are complementary and do not overlap.
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