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Global Environmental and Occupational Health (GEOHealth)
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Training Initiative
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CDC
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NIEHS, FIC, NCI, OD/DPCPSI/ORWH
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The Global Environmental and Occupational Health (GEOHealth) program supports the development of institutions in low- or middle-income countries (LMICs) serving as regional hubs for collaborative research, data management, training, curriculum and outreach material development, and policy support around high-priority local, national and regional environmental and occupational health threats.
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Global Health Security Agenda (GHSA) Action Package Prevent 3 (APP3), Biosafety and Biosecurity Working Group
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Committee, Work group, Advisory group, or Task Force
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CDC, OS
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OD/OSP
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Promotes awareness and implementation of comprehensive national-level biosafety and biosecurity frameworks within the Global Health Security Agenda.
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Global Initiative for Cancer Registry Development (GICR)
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Other
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CDC
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NCI
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Cancer incidence and mortality are rising rapidly worldwide, particularly in low- and middle-income countries. There is an overwhelming need for countries to adopt and implement cancer control actions. Yet only one in five low- and middle-income countries have the necessary data to drive policy and reduce the burden and suffering due to cancer. The Global Initiative for Cancer Registry Development (GICR) is a coordinated, multi-partner approach to deliver the required change. Its objective is to make cancer data count. NCI partners with the U.S. Centers for Disease Control and Prevention to provide technical and financial support to the Caribbean Hub of GICR.
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Global Substance Registration System (GSRS)
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Research Initiative
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FDA
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NCATS
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The Global Substance Registration System, formerly known as the Global Ingredient Archival System (Ginas) is a project that aims to provide a common identifier for all substances used in medicinal products, utilizing a consistent definition of substances globally, including active and inactive substances under clinical investigation, consistent with the ISO 11238 standard. The FDA and other stakeholders around the world including the European Union are utilizing software from this project to meet their obligations under the Identification of Medicinal Products (IDMP) global regulatory scheme. In 2016, the software was deployed onto FDA internal systems and FDA's existing data was migrated into their instance. A public version of FDA's substance definitions for use by researchers outside the agency was made available through NCATS' website for the project. The FDA uses GSRS to publish updates to their substance catalogs on a monthly basis which are also available for public use on the NCATS project site.
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Government-University-Industry Research Roundtable (GUIRR)
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Committee, Work group, Advisory group, or Task Force
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FDA
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NCATS, OD/IMOD
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The National Academies of Sciences, Engineering, and Medicine Government-University-Industry Research Roundtable is charged with improving the research enterprise of the United States by successfully resolving the cross-sectoral issues that prevent the U.S. research enterprise from reaching its full potential. This mission is achieved by convening senior-most representatives from government, universities, and industry to frame the critical issues, followed – when appropriate – by the execution of activities designed to address specific cross-sectoral impediments to achieving a healthy, vibrant research enterprise. GUIRR provides a unique forum for dialogue among top government, university and industry leaders of the national science and technology enterprise.
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Gynecologic Cancer Steering Committee Clinical Trials Planning Meeting: Defining and Targeting Molecular Pathways to Direct Personalized Value-added Treatments for Patients with Epithelial Ovarian Cancer - February 25-26, 2021
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Meeting/ Workshop
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FDA
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NCI
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The meeting objectives were to (1) define current and emerging molecular and clinical classifications of epithelial ovarian cancer subgroups and subsequent implications for trial design and eligibility; (2) design clinical trials that will explore new hypotheses needed to drive targeted treatment approaches in epithelial ovarian cancer; (3) incorporate novel trial designs and clinical endpoints that promote integral patient selection in a personalized medicine approach.
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Harmonization of various Common Data Models and Open Standards for Evidence Generation
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Committee, Work group, Advisory group, or Task Force
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FDA, ONC
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NCI, NCATS, NLM
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The goal of this project is to facilitate the use of Real World Data (RWD) sources (e.g., claims, Electronic Health Records (EHRs), registries, electronic Patient Reported Outcomes (ePRO)) to support evidence generation for regulatory and clinical decision making.
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Harmonization of various Common Data Models and Open Standards for Evidence Generation (CDMH II)
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Resource Development
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FDA
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NCATS, NCI, NLM
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The goal of this project is to build data infrastructure for conducting patient-centered outcomes research using data derived from the delivery of health care in routine clinical settings. These data are collectively referred to as observational data. The sources of these data may include, but are not limited to insurance billing claims, electronic health records (EHRs), and patient registries. The Common Data Model (CDM) organizes data into a standard structure, which may differ across networks. This project intends to harmonize several existing CDMs in order to support research and analyses across multiple data networks. The aim is to advance the utility of data and its interoperability across networks to facilitate patient-centered outcomes research. The enhanced data infrastructure created through this project will have the capacity to support evidence generation on patient-centered outcomes that can inform regulatory and clinical decision making within federal programs.
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HCS Research Collaboratory
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Research Initiative
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AHRQ, CDC, CMS, FDA, OS
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OD/DPCPSI/OSC, OD/DPCPSI/ODP
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The Health Care Systems (HCS) Research Collaboratory program is strengthening the national capacity to implement cost-effective large-scale research studies that engage health care delivery organizations as research partners. The studies funded through this program, referred to as pragmatic clinical trials, engage medical centers across the country in addressing a wide range of pressing public health concerns. The HCS Collaboratory works with representatives from the Food and Drug Administration (FDA), Agency for Healthcare Research and Quality (AHRQ), Office for Human Research Protections (OHRP), and Centers for Disease Control and Prevention (CDC) in order to bring expertise from across HHS to bear on the implementation of these complex pragmatic clinical trials.
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Health and Retirement Study (HRS)
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Research Initiative
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CDC, CMS
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NIA
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This study follows more than 20,000 men and women over 50, offering insight into the changing lives of the older US population. Launched in 1992, this multidisciplinary, longitudinal study has become known as the Nation’s leading resource for data on the combined health and economic conditions of older Americans.
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