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Specificity and Quality of Influenza Specific Antibodies
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Research Initiative
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FDA
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NIAID
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This collaboration supports the evaluation of specificity and quality of influenza specific antibodies in human subjects that have been vaccinated or naturally infected with influenza. Specific tasks include the construction of phage display libraries, production of recombinant proteins, development of surface plasmon resonance assays and the use of these technologies to measure antibody affinity maturation.
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Standardization of Methods to Generate Spiked Clinical Samples for Use in Studies to Support FDA Clearance of Diagnostics for Low Prevalence Pathogens
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Research Initiative
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FDA
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NIAID
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The National Institutes of Health (NIH) has been working with the Food and Drug Administration (FDA) to develop standardized methods to generate clinical samples to assess the performance of diagnostic tests.
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Standards for Genetic Testing Report
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Research Initiative
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AHRQ, CDC, OS
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NLM, NHGRI
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This activity aims to develop a standard reporting format for genetic variations using Logical Observation Identifiers Names and Codes (LOINC) and HL7, for electronic medical records health information exchange, and activities of the Office of the Secretary.
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State Cancer Profiles
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Resource Development
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CDC
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NCI
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The objective of the State Cancer Profiles Web site is to provide a system to characterize the cancer burden in a standardized manner in order to motivate action, integrate surveillance into cancer control planning, characterize areas and demographic groups, and expose health disparities. The focus is on cancer sites for which there are evidence based control interventions. Interactive graphics and maps provide visual support for deciding where to focus cancer control efforts.
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Strategic Multisite Initiative for the Identification, Linkage and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH)
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Research Initiative
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CDC
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NICHD, NIDA, NIMH
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The Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) was awarded grant money to expand their project of increasing availability of HIV testing for adolescents 12-24 and the provision of adolescent-focused healthcare services for those adolescents who are diagnosed with HIV infection. The project’s expansion includes all the ATN sites across the U.S. The Eunice Kennedy Shriver National Institute of Child Health and Human Development is collecting data to evaluate the effectiveness of adolescent oriented linkage to care services for the HIV infected adolescents. This collaboration has the potential to improve the health of American youth, both by identifying those with undiagnosed HIV and bringing them into adolescent-friendly treatment programs and by reducing the chances of them further spreading the virus to others. There is a committee "SMILE in CARING for YOUTH" that monitors activities related to the National Institutes of Health-Centers for Disease Control and Prevention collaboration on enhancing treatment and retention in care of HIV youth.
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Structured Data Capture (SDC) Initiative
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Resource Development
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AHRQ, CDC, CMS, FDA, HRSA, IHS, OS
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NLM, NCI
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The Structured Data Capture (SDC) Initiative is sponsored by the Department of Health and Human Services, Office of the National Coordinator (ONC), as part of the Standards and Interoperability Framework, a program developed to foster collaboration between the public and private sectors to promote interoperable exchange of health data and information. The SDC mission is to develop and validate a data architecture and exchange standards so that a structured set of data can be accessed from electronic health record systems, merged with comparable data and made accessible for purposes other than clinical care, such as research, patient safety and public health. The SDC Working Group on Common Data Elements and Forms, chaired by NLM/NIH with NCI/NIH participation, evaluated and selected two ISO standards to serve as the basis for definitions of Common Data Elements and electronic Case Report Forms (eCRF) under the initiative: ISO/IEC 11179 (Metadata Registries and Data Elements metamodel) and ISO/IEC 19763-13 (Forms metamodel).
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Structured Data Capture Forms and Common Data Element Working Groups
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Other
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AHRQ, CDC, FDA
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NCI, NLM
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This working group designed a Structured Data Capture (SDC) form and Data Element structure, as well as developed XML artifacts and an implementation guide. Provided expertise on ISO 11179 and 19763-13. We participated in a connectathon with CDC and FDA in 2015, and are monitoring activity ongoing. The 2016 connectathon is testing version 2 for the form design, we intend to realign our forms to enable transformation between NCI forms and SDC forms once the standard is stabilized.
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Study of Cancer Among United States Firefighters
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Research Initiative
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CDC
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NCI
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A retrospective cohort study to evaluate the relationship between occupational exposures of firefighters and cancer risk.
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Sub-SPIRIT Ebola Environment Sampling Concept of Operations
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Committee, Work group, Advisory group, or Task Force
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FDA, OS, SAMHSA
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NICHD
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The goal of this effort is to develop concepts of operations (CONOPS) for strategic research, including both controlled-environment and systematic field studies, to improve our understanding of the real-world environmental fate and transport of the Ebola virus to provide additional data to support public health efforts to protect at-risk workers and the public.
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Subpopulations and Intermediate Outcome Measures in Chronic Obstructive Pulmonary Disease (COPD)
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Research Initiative
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FDA
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NHLBI
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SPIROMICS (SubPopulations and Intermediate Outcome Measures In Chronic Obstructive Pulmonary Disease Study) is an observational study of COPD (Chronic Obstructive Pulmonary Disease) that seeks to identify practical intermediate outcome measures and mechanistically homogeneous subgroups of patients with the disease. The study was developed in cooperation with the U.S. Food and Drug Administration and will be implemented with industrial partners.
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