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NCI Multi-Cancer Dectection (MCD) Trial Team
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Research Initiative
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CMS, FDA
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NCI, OD/DPCPSI/ORWH
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Scientific development for the evaluation of Multi-Cancer Detection (MCD) assays for the purpose of cancer screening. This group is also known internally as the Tiger Team
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NCI Scientific Steering Committees (SSCs)
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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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Scientific Steering Committees (SSCs) are composed of leading cancer experts and advocates from outside the Institute as well as NCI senior investigators who meet regularly to: (1) increase the transparency and openness of the trial design and prioritization process; (2) enhance patient advocate and community oncologist involvement in clinical trial design and prioritization; (3) convene Clinical Trial Planning Meetings to identify critical questions, unmet needs, and prioritize key strategies.
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NCI Serological Sciences Network
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Research Initiative
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Not Reported
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NCI, NIAID
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The NCI Serological Sciences Network (SeroNet) is the nation’s largest coordinated effort to study the immune response to COVID-19. The network aims to combat the pandemic by improving the ability to test for infection, especially among diverse populations, and speed the development of treatments and vaccines.
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NCI-DOE Collaboration
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Research Initiative
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Not Reported
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NCI
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The National Cancer Institute - Department of Energy (NCI-DOE) Collaboration, started in June 2016, is an interagency strategic partnership enabled by the National Strategic Computing Initiative and Precision Medicine Initiative. DOE contributes advanced computing and AI expertise along with high performance computing resources. NCI contributes driving cancer research questions along with subject matter expertise and sources of data. Along with the government agencies, multiple DOE national laboratories are involved in this effort along with Frederick National Laboratory for Cancer Research. The goals of the Collaboration are bi-directional - aimed at advancing specific areas of cancer research through application of advanced computing and AI while providing design input for future DOE leadership class computing systems through the application of complex, highly heterogeneous datasets. The Collaboration has produced numerous software tools, data-driven computational models and large-scale, predictive datasets that can be accessed through the NCI Predictive Oncology Models and Data Clearinghouse (MoDaC, modac.cancer.gov) and the Computational Resources for Cancer Research portal (computational.cancer.gov). Other collaborative activity: resource development
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NCI-FDA Joint Fellowship Program (IOTF)
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Training Initiative
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FDA
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NCI
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The objective of the NCI-FDA Joint Fellowship Training Program is to train a cadre of scientists in research and research-related regulatory review, policies, and regulations so that they develop a skill set bridging the two disparate processes. Fellows learn to build awareness of regulatory requirements into the early stages of the medical product development process and develop strategies to improve planning throughout research and regulatory review. There are four different programs tracks within the program. For example, the Clinical Investigator Program track trains physicians in aspects of clinical trials methodology and analysis, epidemiology, clinical aspects of medical product development, and regulation to facilitate the movement of drugs, biologics, and devices from the basic bench science to commercialization. This allows the FDA to gain 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, renewed in 2012, 2017, and 2022 establishes an official relationship in clinical proteomic regulatory science between NCI's Office of Cancer Clinical Proteomics Research and the 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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Collaboration Type also includes: Research Initiative, Resource Development 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). On Friday, September 17, 2021, leadership from the National Cancer Institute (NCI), Food and Drug Administration (FDA), and Health Resources and Services Administration (HRSA) signed a Memorandum of Understanding (MOU) to support solutions for early cancer detection and diagnosis to improve patient outcomes, quality of life, and reduce health disparities among medically underserved, geographically isolated, and otherwise vulnerable populations. The MOU formalizes the establishment of CD2.
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NEHEP Partnership Summit
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Committee, Work group, Advisory group, or Task Force
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OASH
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NEI
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NEHEP was joined by the Office of Disease Prevention and Health Promotion in a partnership summit in 2023 to connect NEI and NEHEP’s work to the Healthy People 2030 vision objectives.
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NEI-FDA-ONC Joint Partnership 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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This virtual NEI, FDA, and ONC hosted workshop focused on delineating the state of the science and improving interoperability among ocular imaging modalities and devices to improve biomedical research and patient care. This meeting consisted of a day of discussion identifying the gaps in knowledge, barriers to progress, and potential strategies for overcoming them in the context of addressing the goal of Promoting the Adoption of Ocular Imaging Standards. This was an open workshop to the general public, attended by researchers from academia, industry, non-profits, other government agencies, patients and care partners. The white paper from this workshop, Accelerating Care: A Roadmap to Interoperable Ophthalmic Imaging Standards in the United States, was published in January 2024. As a follow up to the workshop, NEI published the Standardized Ocular Imaging Expectations for Clinical and Nonclinical Research Funded by NEI notice in May 2024. This notice strongly encourages applicants to use common formats for files and metadata standards when incorporating ocular imaging in their research proposals. This applies to both clinical and nonclinical research applications submitted in response to NOFOs where NEI is the issuing or participating organization. Investigators are strongly encouraged to adopt common formats for files and metadata standards in their research involving ocular imaging. For instance, the Digital Imaging and Communications in Medicine (DICOM) standard, widely used for medical imaging devices, defines formats and accompanying data. Applicants may propose alternative standards provided they meet the necessary requirements for data interoperability, accessibility, and sharing. The widespread adoption of standardized imaging formats will significantly advance the field by:Enabling streamlined digital workflows.Facilitating interoperability of large datasets.Creating extensive training sets for artificial intelligence-based research.By promoting these standards, we aim to foster an environment where data can be seamlessly integrated and analyzed across different studies, enhancing the overall impact of vision research.
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Networking and Information Research and Development (NITRD) National Coordination Office
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Committee, Work group, Advisory group, or Task Force
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Not Reported
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NCI, NHGRI, NIBIB, NIGMS, NLM, OD/DPCPSI/ODSS
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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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