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NCI Clinical Trials and Translational Research Advisory Committee (CTAC)
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Committee, Work group, Advisory group, or Task Force
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CMS, FDA
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NCI
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The Clinical Trials and Translational Research Advisory Committee makes recommendations on the National Cancer Institute-supported national clinical trials enterprise to build a strong scientific infrastructure by bringing together a broadly developed and engaged coalition of stakeholders involved in the clinical trial process. The Committee will provide advice on matters related to the conduct, oversight, and implementation of clinical trials and translational research across the Institute.
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NCI Convenes Workshop on Reproducibility of Fecal Microbiota Transplants in Cancer Therapeutics
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Meeting/ Workshop
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FDA
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NCI, NIAID
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To explore the potential role that fecal microbiota transplants (FMT) and pre/probiotics may play in cancer therapeutics and to address reproducibility and safety to inform translational human studies and clinical trials, NCI convened a “Strategic Workshop on Rigor and Reproducibility: Precision Fecal Microbiota Transplant and Microbiome Cancer Therapeutics” on September 5, 2019. This timely meeting brought together scientists and FDA regulatory staff in the fields of FMT, pre/probiotics, nutrition, microbiome, synthetic biology, biomarkers, computation, immunology, gastroenterology, oncology, and infection. Workshop Goals Assess the current state of clinical research and clinical trials involving FMT and microbiome-based cancer therapeutics; Discuss the knowledge gaps and future opportunities in the field; Provide feedback to National Cancer Institute (NCI) and National Institutes of Health (NIH) regarding future priority areas to enhance precision- and mechanism-based rigor and reproducibility of defined microbiome-based therapeutic clinical research for cancer and other diseases Workshop Focus Areas Standardization (material manufacture and quality control), FMT donor selection, microbiome measurement, clinical protocols, procedures, and trial design; Microbiome composition and function as biomarkers associated with cancer therapy, such as reproducibility, safety, and efficacy; Confounding variables — host genetic and disease state, environment, antibiotics, diet and other lifestyle factors; Clinical efficacy and safety of FMT and microbiome-based cancer therapy; Clinically relevant models and human translational studies; Data sharing; FDA regulatory issues
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NCI Scientific Steering Committees (SSCs)
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Research Initiative
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FDA
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NCI
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FDA engages with the NCI Scientific Steering Committees on their monthly calls, in person meetings, and Clinical Trials Planning Meetings (CTPMs).
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NCI's Surveillance, Epidemiology and End Results (SEER) cancer registry data and the Centers for Medicare & Medicaid Services' (CMS) Medicare Consumer Assessment of Healthcare Providers and Systems (CAHPS®) patient surveys.
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Committee, Work group, Advisory group, or Task Force
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CMS
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NCI
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The SEER-CAHPS data set is a resource for quality of cancer care research based on a linkage between the NCI's Surveillance, Epidemiology and End Results (SEER) cancer registry data and the Centers for Medicare & Medicaid Services' (CMS) Medicare Consumer Assessment of Healthcare Providers and Systems (CAHPS®) patient surveys.
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NCI/CCR-FDA Clinical Investigator Program
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Research Initiative
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FDA
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NCI
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Multilateral Benefit in a Joint Program to Recruit Combined Food and Drug Administration (FDA) and the National Cancer Institute's (NCI) Center for Cancer Research (CCR) Clinical Investigators: the FDA gains an academic oncologist with disease-specific expertise who is actively involved and understands critical nuances of the field; NCI gains a clinical investigator and leader who understands regulatory considerations in drug development; and the oncologic community gains a regulator/academic who will provide a leadership voice to help design trials with regulatory endpoints in mind
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NCI/FDA Memorandum of Understanding for Proteomics
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Research Initiative
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FDA
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NCI
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This Memorandum of Understanding (MOU), signed in 2007 and renewed in 2012, establishes an official relationship in clinical proteomic regulatory science between the National Cancer Institute's (NCI) Office of Cancer Clinical Proteomics Research and the Food and Drug Administration (FDA). Active areas of research collaboration include sample collection, preparation, storage and processing; bioinformatics and data analysis; discovery and validation of biomarkers; and surrogate biomarkers of cancer development and drug response, including standardization among technology platforms and assay standards development.
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NCI/FDA/HRSA/CMS Task Force on Cancer Diagnostic Devices (CD2) for Near-Patient Use
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Committee, Work group, Advisory group, or Task Force
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CMS, FDA, HRSA
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NCI
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The primary goal of this initiative is to develop opportunities that accelerate the pace by which point of care diagnostic devices get to patients for the earlier detection and screening of cancer. The Task Force and Initiative will address cancer types for geographically isolated, medically underserved, and otherwise vulnerable communities, with emphasis to: 1) Cancer types with clear, existing need and highly prevalent, for example cervical cancer; and 2) Cancer types that have evidence of future need from emerging at-risk populations, for example liver cancers derived from nonalcoholic steatohepatitis (NASH).
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Networking and Information Technology Research and Development (NITRD)
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Research Initiative
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AHRQ
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NIGMS
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The Networking and Information Technology Research and Development (NITRD) Program provides a framework in which many Federal agencies come together to coordinate their networking and information technology (IT) research and development (R&D) efforts.
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Neutron Radiobiology and Dosimetry Workshop Meeting Report
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Meeting/ Workshop
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ASPR
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NIAID
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The purpose of this meeting was to work with stakeholders to discuss the current state of dosimetery used in research involving neutrons and mixed field radiation. The discussion examined gaps in knowledge and discuss strategies to plan studies to better inform the research community on the impact neutrons on drug efficacy studies. A meeting report is now being drafted for submission in 2020, as an open source of information for other researchers.
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Newborn Screening Coding and Terminology Guide
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Resource Development
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CDC, FDA, HRSA, IOS
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NLM, NHGRI, NHLBI, NICHD
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This ongoing collaboration develops, supplements, and publicizes a free online resource with guidance to help promote the efficient electronic exchange of standardized newborn screening data. Related efforts include studying the screening process for diseases including severe combined immunodeficiency (SCID), lysosomal storage disorders (LSDs), and critical congenital heart disease (CCHD), and developing standard codes for ordering and reporting the results of newborn screening for SCID, CCHD, and other conditions added to the Uniform Recommended Screening Panel by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children.
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