Department of Health
and Human Services (HHS)
and Human Services (HHS)
NOT-CA-21-050 - Notice of Intent to Publish a Funding Opportunity Announcement for The Early Detection Research Network: Biomarker Characterization Centers (U2C Clinical Trial Not Allowed)
NOT-CA-21-052 - Notice of Intent to Publish a Funding Opportunity Announcement: Early Detection Research Network (EDRN) – Data Management and Coordinating Center
National Cancer Institute (NCI)
The National Cancer Institute (NCI) plans to publish a Funding Opportunity Announcement (FOA) for the establishment of the Clinical Validation Centers (CVCs) of the Early Detection Research Network (EDRN). The EDRN is a national infrastructure to develop and validate biomarkers and imaging methods for early cancer detection and risk assessment. CVCs will conduct research to validate biomarkers and/or imaging methods for risk assessment and detection of early stage cancers. CVCs will also serve as resource centers for collaborative research within the EDRN by providing high-quality specimens for Phase 1 and Phase 2 biomarker refinement studies to other EDRN scientific units, as well as for conducting Network collaborative biomarker validation studies. The CVCs must also have the expertise and ability to conduct Phase 4 clinical utility trials of validated early detection biomarkers and/or imaging methods.
The other two scientific units of the continuing EDRN program are the Biomarker Characterization Centers (BCCs), which will (1) discover, develop, characterize and test new biomarkers or refine existing biomarkers, (2) develop, refine and/or standardize biomarker assays, (3) provide resources and support for the validation of biomarkers developed by the EDRN, and (4) participate in collaborative projects with other laboratories and centers; and the Data Management and Coordinating Center (DMCC), which will support statistical and computational analyses, informatics infrastructure, study design, coordination and management of EDRN-sponsored biomarker validation studies, and the coordination of Network-wide meetings and workshops.
This Notice is released to provide potential applicants with time to consider scientific topics for this program, plan an integrated CVC, and develop the necessary collaborations for the multi-disciplinary, multi-Principal Investigator FOA. Companion Notices for the BCCs and the DMCC are NOT-CA-21-050 and NOT-CA-21-052, respectively.
The CVC FOA is expected to be published in the Spring of 2021 with an expected application due date in the late Summer 2021.
The CVC FOA will utilize the U01 activity code for the research projects. Details of the planned FOA are provided below.
CVCs will conduct research on the validation of biomarkers and/or imaging methods for cancer risk assessment, early cancer detection and early cancer diagnosis and prognosis (i.e., EDRN-defined Phase 2, Phase 3, and Phase 4 validation studies). CVCs will also serve as resource centers for collaborative research within the EDRN by partnering with BCCs to provide high-quality specimens for Phase 1 and Phase 2 biomarker discovery and refinement studies, as well as collaborating with other CVCs, BCCs and the DMCC for conducting Network collaborative biomarker validation studies (collaborative projects will initiate in the second year of the award, which is reflected in the increased budget for Years 2-5, as indicated below).
The CVCs must describe their expertise and ability to design and conduct Phase 4 clinical utility trials of validated early detection biomarkers and/or imaging methods.
Data science, including the use of artificial intelligence (AI) and other machine learning languages (MLL), is poised to play a major role for new or improved risk stratification, early detection, and precision prevention strategies. It is encouraged that CVCs employ computational/mathematical data modeling approaches to predict the translational efficacy of the proposed biomarkers for validation, as this will ensure a greater chance of success in downstream validation phases (Phases 4 and 5) and reaching the clinic. Inclusion of data modeling can enhance the clinical validation efforts by identifying opportunities for precision screening/early detection, provide a better understanding of real-world clinical settings and needs, and also support the development of statistical modeling and simulation models to evaluate the impact of the proposed biomarker tests.
Applications submitted in response to the CVC FOA will be expected to bring translational research skills inherent in academic institutions, scientific and technological expertise in industry, and resources from translational research and disease-oriented networks and health care organizations (e.g., NCI's NCTN, NCORP, CTSA, and Cohort Consortium, NCI-designated Cancer Centers and Cooperative Groups, and HMOs).
The FOA will be open to all qualified applicants, including new and early stage investigators, who can establish and lead a multi-disciplinary, multi-Principal Investigator research projects to enable the fulfillment of the intended program goals.
More details will be outlined in the forthcoming FOA.
NCI intends to commit $10.5M million in FY 2022 and $15M million in FY 2023-2026.
Up to 12.
Each U01 application budget will be limited to $550,000 direct cost for Year 1 (FY 2022), and to $785,000 per year (direct cost) for Years 2-5 (FY 2023-2026).
93.393; 93.394
Applications are not being solicited at this time.
Please direct all inquiries to:
Sudhir Srivastava, Ph.D., M.P.H.
National Cancer Institute (NCI)
240-276-7028
Christos Patriotis, Ph.D.,
National Cancer Institute (NCI)
Telephone: 240-276-7134
Email: [email protected]