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Clinical Research Using Medicare Data from the Virtual Research Data Center (VRDC)
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Research Initiative
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CMS
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NLM
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The National Library of Medicine (NLM) is working with the Centers for Medicare and Medicaid Services (CMS) and other National Institutes of Health (NIH) institutes and centers (ICs) to demonstrate the value of the CMS Virtual Research Data Center (VRDC) as a source of Big Data.
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Clinical Utilization Plan for Anthrax Medical Countermeasure Use in a Mass Casualty Event (CUPAC) Medical Countermeasures Workgroup
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Committee, Work group, Advisory group, or Task Force
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CDC
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CC
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The National Institutes of Health (NIH) Clinical Center is participating as a member of the Medical Countermeasures Work Group to provide clinical algorithms that will assist clinicians to evaluate, triage, diagnose and treat large numbers of patients presenting with symptoms of anthrax. It will also provide a clinical prioritization schema for the use of medical countermeasures specific to anthrax and outline unique critical care issues that may require special consideration.
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Clinical Vocabulary and Standards Development for Meaningful Use of Electronic Medical Records
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Committee, Work group, Advisory group, or Task Force
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AHRQ, CDC, CMS, OS
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NLM
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The National Library of Medicine (NLM) is collaborating with the Office of the Secretary OS and the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) on developing and disseminating regulatory language related to health information technology, meaningful use, and standards and certification criteria related to electronic health records and messaging. The collaboration includes serving as members of the Content Standards Workgroup, and Semantic Standards Workgroup of the Health IT (HIT) Standards Committee. The HIT Standards Committee is a Federal advisory committee that was created by the Health Information Technology for Economic and Clinical Health (HITECH) Act to provide input to HHS on the policies and technologies needed to improve health and care.
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ClinicalTrials.gov
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Resource Development
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FDA
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NLM, CC, NCATS, NCCIH, NCI, NCMHD, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, OD/OER, OD/OSP
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ClinicalTrials.gov is a National Library of Medicine (NLM) operated database containing summary protocol and results information from publicly and privately funded clinical research studies. As of December 2018, the database included summary protocol information on more than 292,000 clinical studies conducted in 207 countries, with nearly 34,000 records displaying summary results. NLM originally collaborated with the Food and Drug Administration (FDA) on implementing Section 113 of the Food and Drug Administration Modernization Act of 1997. It subsequently collaborated with FDA, the Department of Health and Human Services (HHS) Office of the General Counsel (OGC), and the National Institutes of Health (NIH) Office of the Director (OD) to implement the statutory requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 through rulemaking. Regulations (42 CFR Part 11) were promulgated in September 2016. NLM continues its collaboration with FDA, OGC, and other parts of NIH to implement the requirements under 42 CFR Part 11 and provide educational information and conduct outreach activities. NLM is also continuing its collaborating with NIH OD and other parts of NIH to implement the 2016 NIH Policy on the Dissemination of NIH-funded Clinical Trial Information and other NIH policies (e.g., reporting results of valid analyses by sex/gender and race/ethnicity for NIH-funded trials to ClinicalTrials.gov as required by the 21st Century Cures Act). Finally, NLM has worked closely with OD/OSP to assist OHRP in preparing to implement the Posting of Clinical Trial Consent Form provision of the revised Common Rule at 45 CFR 46.116(h).
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CMS End-stage Renal Disease (ESRD) Affinity Group
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Committee, Work group, Advisory group, or Task Force
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CMS
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NIDDK
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CMS has established a number of affinity groups to focus groups of individuals interested in and working on particular topics -- in this case, end-stage renal disease (ESRD). The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Program staff have participated in meetings, bringing domain expertise and perspectives on current research findings.
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CMS-NIH Senior Leadership Council
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Committee, Work group, Advisory group, or Task Force
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CMS
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OD/OSP, NCATS, NCI, NHGRI, NHLBI, NIA, NIDA, NIDDK, OD/IMOD, OD/OER
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Facilitates leadership-level development of mutual priorities between both HHS operating divisions.
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Collaborative for Enhancing Emergency Care Research in LMICs (CLEER)
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Meeting/ Workshop
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CDC
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FIC, NICHD, NINDS
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The Fogarty International Center (FIC) hosted a meeting and writer’s workshop titled “Collaborative for Enhancing Emergency Care Research in LMICs (CLEER)” in 2017. The workshop brought together researchers from high-income countries (HICs) and low-and middle-income countries (LMICs) to define challenges and propose solutions for conducting research in acute care settings in LMICs, including but not limited to (i) data definitions, collection, analysis, comparison and solutions including the use of technology and (ii) research ethics. At the conclusion of the workshop, six manuscripts were started by working groups and written primarily in 2018 for publication in the scientific journal, BMJ Global Health. The manuscripts are entering the final stages of submission/review for publication and will be disseminated at relevant conferences, meetings, and panel discussions.
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Collaborative on Healthy Parenting in Primary Care
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Public Education Campaign
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CDC, HRSA, SAMHSA
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NICHD
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The Collaborative on Healthy Parenting in Primary Care recognizes the accumulated evidence of the effectiveness of family-focused prevention programs that promote the physical and behavioral health and emotional well-being of children from before their birth through adolescence. Members of the Collaborative have united around an initiative to support the integration of effective programs that promote healthy parenting into primary care settings in order to achieve optimal health for children.
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Combating Antibiotic Resistant Bateria (CARB)
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Resource Development
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CDC, FDA
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NLM, NHGRI, NIAID
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The National Action Plan for Combating Antibiotic-resistant Bacteria is a multi-agency initiative to deal with the threat of increasing antibiotic resistance. The National Center for Biotechnology Information (NCBI) has a part in Sub-Objective 2.1.4: Develop and maintain a national sequence database of resistant bacteria.
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Common Data Elements (CDE) for Patient-Centered Outcomes Research
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Resource Development
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OS
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NLM, CC, CIT, NCATS, NCI, NEI, NHGRI, NHLBI, NIA, NIAID, NIAMS, NICHD, NIDA, NIDDK, NIEHS, NIMH, NINDS, NINR, OD/OER
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Led by the National Library of Medicine (NLM), a Task Force of the National Institutes of Health (NIH) Scientific Data Council and others are working to promote the use of common data elements in research, surveillance, and patient registries to facilitate data sharing and reuse. Work to date has produced a portal of NIH projects that use Common Data Elements (CDEs) and, with the assistance of funding to develop data infrastructure to promote patient-centered outcomes research (OS Patient-Centered Outcomes Research Trust Fund), will contribute to development of a search, retrieval, and repository mechanism that will support and reflect the standards work of the Standards & Interoperability (S&I) Framework Structured Data Capture Initiative. This project contributes to efforts to develop a repository and search tool for identification of CDEs for Patient-Centered Outcomes Research. Initially formed as a work-group of the Trans-NIH BioMedical Informatics Coordinating Committee (BMIC), and changed to SDC Task Force in 2016.
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