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NCI/FDA Federal Investigator Registry of Biomedical Information Research Data (FIREBIRD)
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Resource Development
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FDA
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NCI
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An agreement has been reached by the U.S. Food and Drug Administration and the National Cancer Institute to manage and share information about clinical investigators using the Federal Investigator Registry of Biomedical Information Research Data, or FIREBIRD, system. Drug makers are encouraged to also submit information about investigators electronically to the new registry. FIREBIRD is the first module of an expected suite of software programs that will comprise a system called the Clinical Research Information Exchange (CRIX). CRIX is intended to support the biomedical and biopharmaceutical research community by streamlining the document and data exchange process. The resulting reduction of paperwork is expected to increase the efficiency and lower the cost of conducting clinical trials.
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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
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The National Cancer Institute (NCI) Enterprise Vocabulary Services is working with the U.S. Food and Drug Administration (FDA) to develop and support controlled terminology in several areas. More than 10,000 FDA terms and codes are stored in the NCI Thesaurus.
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NCI/FDA Memorandum of Understanding for Proteomics
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Research Initiative
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FDA
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NCI
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This Memorandum of Understanding (MOU), signed in 2007 and renewed in 2012, establishes an official relationship in clinical proteomic regulatory science between the NCI (Office of Cancer Clinical Proteomics Research) and the FDA. Active areas of research collaboration include sample collection, preparation, storage and processing; bioinformatics and data analysis; discovery and validation of biomarkers; and surrogate biomarkers of cancer development and drug response, including standardization among technology platforms and assay standards development.
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NEI/FDA Symposium – Ocular Inflammatory Diseases
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Meeting/ Workshop
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FDA
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NEI
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Meeting with FDA to develop outcome variables for use in clinical trials of drugs in ocular inflammatory diseases.
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NEI/FDA Symposium: NEI-FDA Diabetic Retinopathy Clinical Trial Endpoints Symposium
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Meeting/ Workshop
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FDA
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NEI
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Meeting with FDA to develop outcome variables and study designs for use in clinical trials of treatments for diabetic retinopathy.
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Nested Case-Controlled Study of Lung Cancer and Diesel Exhaust Among Non-Metal Miners
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Research Initiative
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CDC
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NCI
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A retrospective cohort mortality and nested case-control study of about 12,315 non-metal miners (278,041 person-years) to investigate risk of lung cancer in relation to quantitative measures of exposure to diesel exhaust.
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Neural Interfaces Conference
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Meeting/ Workshop
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FDA
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NIBIB, CSR, NEI, NIA, NICHD, NIDCD, NINDS
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The Neural Interfaces research community consists of investigators, supported by grants or contracts, who are working in areas that include functional neuromuscular/electrical stimulation, auditory prosthesis, cortical prosthesis, neuromodulation, microelectrode array technology, brain computer/machine interfaces and other related areas. Conferences were held in 2010 and 2012 and most recently in June 2014. The next planned conference is scheduled to be held in June 2016.
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Newborn Screening Coding and Terminology Guide
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Resource Development
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CDC, HRSA, OS
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NLM, NHGRI, NHLBI, NICHD
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This ongoing collaboration develops, supplements and publicizes a free online resource with guidance to help promote efficient electronic exchange of standardized newborn screening data. Related efforts include studying the screening process for diseases including severe combined immunodeficiency (SCID), lysosomal storage disorders (LSDs), and critical congenital heart disease (CCHD), and developing standard codes for ordering and reporting the results of newborn screening for SCID, CCHD, and other conditions added to the Uniform Recommended Screening Panel by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children.
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Newborn Screening Federal Partners Committee
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Committee, Work group, Advisory group, or Task Force
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CDC, HRSA
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NICHD, NHLBI, NLM
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The National Institutes of Health, Health Resources and Services Administration, Centers for Disease Control and Prevention (CDC), the American College of Medical Genetics and the Genetic Alliance meet monthly, in person or online, to discuss and coordinate current activities and initiatives in newborn screening. Topics include the activities of the Newborn Screening Translational Research Network Coordinating Center, the Clearinghouse of Newborn Screening Information, Sickle Cell Screening Programs, the CDC Newborn Screening Quality Assurance Program, and the Regional Newborn Screening Collaboratives.
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Newborn Screening Pompe Pilot Study
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Research Initiative
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CDC, FDA, HRSA
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NICHD
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The purpose of this research initiative is establishing a resource to be used to support the development and rapid data collection of Pompe Disease to be added to the Recommended Uniform Screening Panel (RUSP) and to pilot the development and rapid data collection of a Pompe Disease newborn screening assay. This project supports the development of a Pompe Disease screening method in the newborn screening environment by establishing a pool of high throughput newborn screening laboratories (state and private) with the capacity to screen a large number of newborns in relatively short periods of time (12-18 months). These groups address follow-up and educational needs stemming from pilot studies for the newborn screening system.
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