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Trans-NIH Working Group for Objective Measures in Cancer
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Committee, Work group, Advisory group, or Task Force
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FDA
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NCI, NIBIB, NIDDK
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An National Institutes of Health (NIH) working group was formed to develop and consolidate wearable, passive and continuous out-of-clinic monitoring strategies for clinical assessment and understanding of disease progression in cancer. The goal of this group and its activities is to examine how these devices and techniques can be used to assess and understand cancer progression from multi-parameter data (context, vitals, and/or chemistry). Currently, several non-HHS agencies (National Institute of Standards and Technology (NIST), Department of Defense (DoD), Department of Energy (DOE), the National Aeronautics and Space Administration (NASA) and HHS agencies (NIH and the Food and Drug Administration) are also involved in these discussions and will integrate their expertise/mission to propagate for medical purposes.
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Translational Science Interagency Fellowship (TSIF)
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Training Initiative
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FDA
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NCATS
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The Translational Science Interagency Fellowship (TSIF) program is jointly sponsored by NCATS and the U.S. Food and Drug Administration (FDA) and aims to provide training in both translational science and regulatory science. The common goal of NCATS and the FDA is to bring safe and effective drugs, regimens and devices from the bench to the bedside as quickly and efficiently as possible. To that end, fellows will be trained in preclinical translational science, technology development, and regulatory research and review.
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Transplant Cancer Match Study
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Research Initiative
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HRSA
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NCI
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A study linking databases of US transplant recipients, donors, and waitlist candidates to multiple US cancer registries to evaluate the spectrum of cancer risk and outcomes in the transplant population.
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Trial to Assess Chelation Therapy 2 (TACT2)
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Research Initiative
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CDC
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NIDDK, NCCIH, NHLBI, NIEHS
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TACT2 is a clinical trial to determine whether intravenous (IV) Na2EDTA chelation therapy with oral (by mouth) multivitamins will reduce the risk of major cardiovascular events (such as stroke and heart attack) in patients who have already had a heart attack and who also have type 2 diabetes.
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Trial Transparency via Registration and Results Reporting at NIH 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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Tribal Epidemiology Centers Program
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Research Initiative
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IHS, CDC
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NIMHD, OD/DPCPSI/THRO
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The Tribal Epidemiology Centers Program develops Epidemiology Centers and public health infrastructure for American Indian/Alaska Native communities.
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Tribal Health Research Advisory Council (HRAC)
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Committee, Work group, Advisory group, or Task Force
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ACF, AHRQ, CDC, HRSA, IHS, OS, SAMHSA
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NIMHD, OD/DPCPSI/THRO
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The National Institutes of Health (NIH) supports the activities of the Tribal Health Research Advisory Council (HRAC), including obtaining input from tribal leaders on health research priorities and needs, and dissemination of information.
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Tularemia Animal Model Qualification Working Group
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Committee, Work group, Advisory group, or Task Force
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BARDA, FDA
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NIAID
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This working group is collaborating on the qualification of a primate model of pneumonic tularemia under the Food and Drug Administration (FDA) Animal Model Qualification/Drug Development Tools Program. Animal model qualification is a regulatory decision and will be published on the FDA website when final. The collaboration includes the exchange of study data, study reports, and agreements on regulatory strategy for model qualification.
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Tumor Mutational Burden (TMB) Harmonization Project
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Resource Development
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FDA
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NCI
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The project conducts analytical and clinical validation studies to support a standardized method of (tumor mutational burden) TMB measurement to enable consistent TMB reporting in a clinical setting despite differences in the testing panel used.
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U.S. and Canada Human Milk Composition Initiative (HMCI)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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NICHD, OD/DPCPSI/ODS, NIDDK, NCI
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Coordinate and support the development of human milk composition data in the U.S. and Canada for use by federal policy, program and other stakeholders to provide nutrition and dietary guidelines, education and programs for infants.
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