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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 Pharmacology Quality Assurance Program (CPQA)
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Other
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CDC
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NIAID
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The Clinical Pharmacology Quality Assurance program provides proficiency test materials for the DAIDS clinical pharmacology labs, both domestic and internationally. The Proficiency testing panels include replicate samples of antiretroviral drugs of unknown concentration, which are determined by the labs using liquid-chromatography mass spectrometry (LC-MS/MS) methodology. Labs must determine concentrations with high accuracy and precision to 'Pass" the panel. In a partnership with the Center for Disease Control, two of their labs have been included to participate in the CPQA proficiency Testing Program. They ae the International Laboratory Branch Bioanalytical Laboratory and the Analytical and Clinical Evaluations Laboratory of the domestic CDC HIV Prevention Program. The CPQA also did validations of their drug quantification assay protocols and have conducted site visits to evaluate their operations. The CPQA contract operates through TRP in DAIDS.
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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) works 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 data for research purposes. NLM's Clinical Data Discovery branch uses the VRDC to answer useful epidemiologic and clinical questions, specifically about drug benefits and possible harms.
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Clinical Trials of Biodefense Vaccines (Dengue)
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Research Initiative
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CDC
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NIAID
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Clinical Trials of Biodefense Vaccines (Dengue)
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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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Resource Development
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CDC, CMS, FDA, ONC
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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, maintaining, and disseminating clinical terminologies and codes related to health information technology, electronic health records, and messaging.
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CMS MCBS, Dietary Supplements, Measures of Malnutrition and Frailty
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Health Survey
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CMS
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OD/DPCPSI/ODS
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The National Institutes of Health's, Office of Dietary Supplement has been working with the Centers of Medicare and Medicaid Service to collect data on dietary supplement use, malnutrition and measures of frailty in the Medicare Current Beneficiary Study (MCBS). MCBS is a nationally representative survey that collects health and Medicare claims data from participants multiple times per year for up to 4 years. This information will be very helpful in assessing risk of malnutrition and frailty. Since the participants data are linked to their Medicare claims data, information can be validated against claims data, with the possibility for outcomes also to be assessed.
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CMS-NIH 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, NCCIH, NCI, NHGRI, NHLBI, NIA, NIDA, NIDDK, NIMHD, OD/IMOD, OD/OER
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Facilitates leadership-level development of mutual priorities between both Department of Health and Human Services (HHS) operating divisions.
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CMS/NIH/NHLBI Sickle Cell Disease Working Group
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Meeting/ Workshop
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CMS
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NHLBI
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Working group that meets to explore what is required to implement CMS coverage for curative therapies in SCD.
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Collaborative Acute Toxicity Modeling Suite (CATMoS)
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Committee, Work group, Advisory group, or Task Force
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ATSDR, CDC
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NIEHS, NCATS
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With the increasing number of chemicals to assess for acute oral systemic toxicity potential (LD50) and the lack of in vitro approaches, the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), Acute Toxicity Workgroup organized an international collaborative project to develop in silico models as alternatives to predict LD50 and bridge data gaps. Participants from 35 groups submitted a total of 139 predictive models built using a dataset of 11,992 chemicals split into training (75%) and evaluation sets (25%). Crowdsourced models were developed for five endpoints: LD50 value, EPA hazard categories, GHS hazard categories, very toxic (LD50 < 50 mg/kg), and non-toxic (LD50 > 2000 mg/kg). Predictions within the applicability domains of the submitted models were evaluated, then combined into consensus predictions based on a weight-of-evidence approach. The resulting consensus model, forming the Collaborative Acute Toxicity Modeling Suite (CATMoS), leverages the strengths and overcomes the limitations of individual modeling approaches. The consensus predictions are fully reproduceable and performed at least as well as independent replicate in vivo acute oral toxicity assays. The CATMoS consensus model is available via the free and open-source tool OPERA (Open Structure-activity/property Relationship App).
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