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Children's HHS Interagency Leadership on Disasters (CHILD) Working Group
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Committee, Work group, Advisory group, or Task Force
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ACF, CDC, HRSA, OS, SAMHSA
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NICHD, NIAID, NIDA, NIGMS, NIMH
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The U.S. Department of Health and Human Services (HHS) established the Children's HHS Interagency Leadership on Disasters (CHILD) Working Group in 2010 to identify and comprehensively integrate the activities related to the needs of children across all HHS inter- and intra-governmental disaster planning activities and operations. Co-led by the Administration for Children and Families and the Assistant Secretary for Preparedness and Response, the group then developed recommendations for how HHS can improve the delivery of care to children who are impacted by disasters.
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Circulating Estrogens, Androgens, and Progestogens and Risk of Breast Cancer in the PLCO Cohort
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Research Initiative
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CDC
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NCI
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In a stratified cohort study of breast cancer in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO), restricted to postmenopausal women not on menopausal hormone therapy, researchers are using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay recently developed by the Centers for Disease Control and Prevention (CDC) to assess pre-diagnostic circulating levels of the endogenous steroid hormones believed to be involved in breast cancer etiology. Although it is known that endogenous hormones play a critical role in the etiology of breast cancer, the interrelationships among estrogens, androgens, and progesterone in determining risk are not well understood.
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CLARITY - Mammary Gland efforts
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Research Initiative
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ATSDR
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NIEHS
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Collaboration between Fenton lab at NIEHS and Soto lab at Tufts University to study BPA effects on mammary gland
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Clinical and Translational Research Course for PhD Students
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Training Initiative
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FDA
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CC, NCATS, NCI, NHLBI, NIAID, NIDA, NIDCR, NIDDK, NIGMS, NIMH, NINDS
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The Clinical and Translational Research Course for PhD Students is a two-week intensive introductory course for graduate students in the basic biomedical sciences who have at least one year of graduate study. The purpose of the course is to demonstrate and highlight the roles of PhD scientists in clinical and translational research, to provide an overview and examples of how basic science and clinical observations lead to translational research, and to increase awareness and access to PhD role models, research resources, and potential career opportunities at the National Institutes of Health (NIH).
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Clinical Investigator Interagency Working Group for the Development of Antiviral Influenza Therapeutics
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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NIAID
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This working group discusses a range of issues relevant to the development of antiviral drugs for the treatment of influenza.
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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, IOS
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NLM
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The National Library of Medicine (NLM) collaborates 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) and other parts of HHS 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.
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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/DPCPSI/OBSSR, OD/OER, OD/OLPA, 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 September 2019, the database included summary protocol information on nearly 370,000 clinical studies conducted in 219 countries, with approximately 47,000 of these 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, OD/OSP, OGC, and other parts of NIH to implement the requirements under 42 CFR Part 11, provide educational information, conduct outreach activities, and develop compliance workflows and reporting tools. 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). Additionally, NLM worked closely with OD/OSP to assist OHRP in implementing the Posting of Clinical Trial Consent Form provision of the revised Common Rule at 45 CFR 46.116(h). NLM has also been working with OD/OBSSR to develop resource materials specific to researchers in the field of behavioral and social science to better support submission of their research to ClinicalTrials.gov. Finally, NLM has been collaborating with OD/OSP, OER, OLPA, and OCPL on analyzing approaches for reporting NIH-funded basic experimental studies with humans.
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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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The Centers for Medicare and Medicaid Services (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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