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Comparison of Age-related Macular Degeneration (AMD) Treatment Trials
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Research Initiative
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CMS
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NEI
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Head-to-head Comparative Effectiveness Trial between two chemically related anti-VEGF treatments for Age-related Macular Degeneration.
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Comprehensive Assessment of Occupationally-Relevant Exposures- Welding Fume
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Research Initiative
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CDC
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NIEHS
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The purpose of these studies is to identify possible candidate industries, labor unions and workplaces with occupational exposures to welding fumes (WF) with special emphasis on manganese (MN) and recruit their participation in an exposure assessment study.
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Computational Toxicology for NIH Medications Discovery
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Research Initiative
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FDA
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NIDA
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Through an Inter-Agency Agreement, the FDA provides structure-activity relationship-based toxicity predictions for compounds that are under evaluation in the NIDA Addiction Treatment Discovery Program. On a limited basis, other NIH institutes and centers may utilize this resource by working through NIDA.
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Computer Models and Validation for Medical Devices Workshop
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Meeting/ Workshop
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FDA
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NHLBI, NIBIB
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This has been an annual summer workshop organized by the FDA, NIH, and NSF on computer models of medical devices, although the workshop was suspended in 2012. Planning for the 2013 workshop began in 2012, and will focus on identifying the conditions under which computer-simulated human-response data can be used to support a regulatory submission to the FDA.
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Computer-aided Diagnosis for Radiology Images
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Research Initiative
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FDA
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CC
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The collaboration focuses on the improvement of computer-aided diagnosis for radiology images. Specific applications include computer-aided polyp detection for CT colonography, improvements in the conduct and analysis of observer performance experiments using radiology images and the use and development of advanced machine learning and receiver operating characteristics methods with application to computer-aided diagnosis.
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Conducting Comprehensive Toxicological Assessments
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Research Initiative
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FDA
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NIEHS
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The purpose of this Agreement is to conduct, at FDA/NCTR, comprehensive toxicological assessments on FDA priority chemicals/agents nominated to the National Toxicology Program. Studies can include range finding sub-chronic and chronic, compound-specific mechanistic studies, and consideration of the use of alternate test systems. This combination of studies is designed to facilitate the interpretation of study results in support of comprehensive quantitative human health risk assessments. The primary goal of this program is to develop a comprehensive scientific data base that can be utilized to reduce the uncertainty in risk assessment/risk benefit analysis for specific chemicals with high FDA impact.
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Congenital Heart Disease Expert Meeting
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Meeting/ Workshop
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CDC
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NHLBI
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The goal of this CDC-sponsored meeting was to develop a public health research agenda for congenital heart disease. An NHLBI representative participated on the committee with CDC members that planned and oversaw the meeting. Fifty invited experts attended the meeting representing diverse expertise in content (congenital heart disease, adult heart disease, statistics), methods (public health strategies), and personal experience. The group included persons from varied backgrounds (physicians, surgeons, epidemiologists, public health officials, advocates, and patients), with a broad representation of public health, professional, and CHD advocacy organizations. The meeting focused on four specific areas including epidemiology, health services, long term morbidity and mortality, and long term psychosocial and neurodevelopmental outcomes. The findings from the meeting were summarized in a manuscript which will be published in a cardiology or public health journal.
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Congenital Heart Public Health Consortium
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Resource Development
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AHRQ, CDC
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NHLBI
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The Congenital Heart Public Health Consortium (CHPHC) is a group of organizations uniting resources and efforts in public health activities. The mission of the CHPHC is to prevent congenital heart defects and improve outcomes for affected children and adults. The consortium achieves its mission by providing leadership and a unified voice for public health priorities, expanding opportunities for surveillance and public health research, and informing public policy priorities that benefit public health and affected persons. The CHPHC represents various federal, state, and community organizations, including those representing patient/family, clinical, and research interests. It is pooling expertise and experience and using a public health model to address CHD issues across the lifespan.
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Consensus Development Conference: Diagnosing Gestational Diabetes Mellitus
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Meeting/ Workshop
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AHRQ
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OD/DPCPSI/ODP, NICHD
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Gestational diabetes mellitus (GDM) is a condition in which women without previously diagnosed diabetes exhibit high blood glucose levels during pregnancy (especially during the third trimester of pregnancy). In collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the NIH Office of Disease Prevention organized a Consensus Development Conference to better understand the benefits and risks of various GDM screening and diagnostic approaches. After weighing the evidence presented by speakers and an evidence report, an unbiased, independent panel prepared and presented a consensus statement addressing the key questions. The conference was held on March 4-6, 2013.
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Consortium for Tuberculosis (TB) Biomarkers (CTB2)
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Research Initiative
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FDA
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NIAID
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The Consortium seeks to establish a robust biorepository of well-documented clinical specimens to support the discovery and qualification of biomarkers of Tuberculosis (TB) drug effect, especially surrogate markers for stable cure vs. relapse, and to facilitate development of rapid, reliable TB diagnostics, including tests for drug-susceptibility that would be practical for use in resource poor settings.
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