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NCI Cervical Cancer "Last Mile" Initiative (LMI)
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Research Initiative
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FDA, CDC
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NCI
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The NCI Cervical Cancer ‘Last Mile’ Initiative (LMI) is a public private partnership between several stakeholders (including federal agencies, industry partners, and professional societies/clinical practice guidelines organizations) to validate self-sampling-based HPV testing approaches as comparable (non-inferior) alternatives to provider-collected cervical specimen for HPV testing in cervical cancer screening, and accelerate progress towards regulatory approvals.
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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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Committee, Work group, Advisory group, or Task Force
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FDA
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NCI
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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;NCI Fecal Microbiota Transplants and Defined Microbiota Cancer Therapeutics Clinical Research Working Group;Since 2019 NCI FMT workshop, the Working Group continues hosting seminar series,;yearly to highlight the research discovery and assess the research needs. The most recent webinar is on Nov 6, 2022 in which Drs. Hassane Zarour and Giorgio Trinchieri, the world experts on FMT and cancer immunotherapy, discussed NCI funded study published in Science this year “Fecal microbiota transplant overcomes resistance to anti-PD-1 therapy in melanoma patients”. The next coming FMT talk will be on April 8th, 2022, at 2pmIn addition to the webinar, in FY 2022,;Working Group;is working on developing FOA: RFA:;Fecal Microbiota Transplants and Defined Microbiota Cancer Therapeutics Clinical Research Network.;Plan to present in DCTD meeting in April, May or July.Plan future meeting in 2024. NCI workshop on the “State of the Science: Cancer Complementary and Alternative Medicine Therapeutics Research” and the recent upsurge in the field of gut microbiota research suggest that the microbiome plays a role in cancer therapeutic outcomes. This may be especially important for patients receiving anti-PD-1 immunotherapy. 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 (agenda). 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 GoalsAssess the current state of clinical research and clinical trials involving FMT and microbiome-based cancer therapeuticsDiscuss the knowledge gaps and future opportunities in the fieldProvide feedback to NCI and 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 diseasesWorkshop Focus AreasStandardization (material manufacture and quality control), FMT donor selection, microbiome measurement, clinical protocols, procedures, and trial designMicrobiome composition and function as biomarkers associated with cancer therapy, such as reproducibility, safety, and efficacyConfounding variables — host genetic and disease state, environment, antibiotics, diet and other lifestyle factorsClinical efficacy and safety of FMT and microbiome-based cancer therapyClinically relevant models and human translational studiesData sharingFDA regulatory issues
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NCI Enterprise Vocabulary Services (EVS) controlled terminology and standards development in collaboration with FDA and international regulatory agencies including NCI/FDA Memorandum of Understanding for Drug Related Information
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Resource Development
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FDA
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NCI
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The National Cancer Institute (NCI) Enterprise Vocabulary Services is working with the US Food and Drug Administration (FDA) to develop and support controlled terminology in several areas. More than 25,800+ FDA terms and codes are stored in the NCI Thesaurus.
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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 and 2017, 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 NCI, FDA, Health Resources and Services Administariton (HRSA) and CMS partnered in late 2019 to establish the Interagency Cancer Diagnostic Devices (CD2) Task Force for Near-Patient Use. Near-patient diagnostics generally refers to a system whereby a sample is analyzed, and the results are delivered in the same location and while the patient is being evaluated. Near-patient diagnostics are often offered at point-of-care settings where at-home tests may be available with a prescription or purchased over-the-counter. CD2 is a collaborative effort among four federal partners working together within and across their respective missions to bring more soluctions to: detect and diagnose cancer earlier; enhance identification of patients at high risk of developing cancer and surveillance of those at risk of cancer recurrence; improve monitoring of patient response during cancer treatment; and reduce the effect of health disparities and equitably extend the benefits of health care to all populations. 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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NEI-FDA-ONC Joint Workshop on Promoting Adoption of Ocular Imaging Standards
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Meeting/ Workshop
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FDA, ONC
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NEI
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Virtual Workshop on Tuesday, May 10, 2022 from 10:00a – 5:00p EST Agenda: Session 1: Where are we now and where do we want to be? NEI Director, Dr. Michael Chiang, will open the day by describing a “Vision for the Future” with broad interoperability in ocular imaging; to expand research opportunities and play a role in improving patient care and quality of life.;Session 2:;Ocular imaging basics, technical hurdles, and regulatory standards and recommendations. This section will describe the role of each organization (NEI, ONC, FDA) in ensuring interoperability. Presentations will be focused on research on imaging (what is possible and what isn’t until we address some gaps), FDA regulations on devices, and ONC efforts for interoperability with EHR. Session 3:Will showcase different viewpoints on how to address barriers to adoption of DICOM. Session 4:;Will focus on how compliance might be evaluated and what else is needed beyond DICOM in its current state.;;Session 5:;Panelists from NEI, ONC, FDA, ; AAO will present their ideas for approaches to address the challenges for imaging standardization to improve the eco-system of ocular imaging.;;
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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 strategies to plan studies to better inform the research community on the impact neutrons on drug efficacy studies. A meeting report was peer reviewed and published in 2021 as an open source of information for other researchers.
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