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Clinical Islet Transplantation Consortium
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Research Initiative
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CMS, FDA
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NIDDK, NIAID
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The Clinical Islet Transplantation (CIT) Consortium is a network of clinical centers and a data coordinating center established in 2004 to conduct studies of islet transplantation in people with type 1 diabetes. Studies conducted by the CIT Consortium will focus on improving the safety and long-term success of methods for transplanting islets, the insulin-producing cells of the pancreas, in people whose own islets have been destroyed by the autoimmune process that characterizes type 1 diabetes. One clinical trial, in particular, is studying the efficacy of islet transplantation after kidney transplantation. Participants may include Medicare beneficiaries. This study was mandated in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
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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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NLM is working with CMS and other NIH ICs to demonstrate the value of the CMS Virtual Research Data Center (VRDC) as a source of Big Data.
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Clinical Trial Designs for Emerging Infectious Diseases
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Meeting/ Workshop
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CDC, FDA
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NIAID
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This workshop was hosted by the FDA in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), and the CDC.This workshop explored the ethical and methodological assumptions behind the choice of different trial designs, described different types of emerging infectious diseases of concern, and then explored several clinical trial designs for both vaccines and therapeutic products. Participants discussed the scientific, ethical, and practical issues considered in the choice of specific trial designs, and the generalizability of these designs for other types of emerging infectious diseases.
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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 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 number 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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NLM is collaborating with OS and 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. 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 an NLM-operated database containing summary protocol and results information from publicly and privately funded clinical research. As of December 2016, the database included summary protocol information on more than 230,000 clinical studies conducted in over 195 countries, with nearly 24,000 records displaying summary results. NLM originally collaborated with FDA on implementing Section 113 of the Food and Drug Administration Modernization Act of 1997. It subsequently collaborated with FDA and NIH OD to implement the statutory requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 through rulemaking. The final rule (42 CFR Part 11) was issued in September 2016. NLM is currently collaborating with FDA and other parts of NIH to implement the regulatory requirements of 42 CFR Part 11.
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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). NIDDK Program staff have participated in meetings, bringing domain expertise and perspectives on current research findings.
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CMS-FDA-NIH Trilateral Council
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Committee, Work group, Advisory group, or Task Force
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CMS, FDA
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OD/OSP, NIA, OD/OER
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The CMS-FDA-NIH Trilateral Council provides a forum for agency leaders to discuss policy issues, programs, and research initiatives of mutual interest and determine appropriate interfaces and collaborations that may inform NIH-funded research, FDA guidance and regulations, and CMS policies and programs. The Council formed in April 2016 and meets at the request of the Chairs: the NIH Director, FDA Commissioner, and CMS Administrator.
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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, NIA, OD/OER
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The CMS-NIH Senior Leadership Council provides a forum for agency leaders to discuss policy issues, programs, and research initiatives of mutual interest and determine appropriate interfaces and collaborations that may inform NIH-funded research and CMS policies and programs. The Leadership Council is co-chaired by the NIH Director and CMS Administrator, and meets at the request of the Chairs.
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CMS/CDC/FDA/NIH Opioid Abuse Collaboration
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Committee, Work group, Advisory group, or Task Force
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CDC, CMS, FDA
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NIA, NIDA, NINDS
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The purpose of this collaboration is to discuss agency activities surrounding the HHS Secretary’s opioid abuse initiatives.
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