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-21-051 - Notice of Intent to Publish a Funding Opportunity Announcement: Early Detection Research Network (EDRN) – Clinical Validation Centers
National Cancer Institute (NCI)
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for a Data Management and Coordinating Center (DMCC), one of the three scientific units of the Early Detection Research Network (EDRN). The EDRN is a national infrastructure to discover, develop, and validate biomarkers and imaging methods for early cancer detection and risk assessment. The proposed DMCC will be responsible for the following activities: 1) Network Coordination, 2) Data Science, Data Management and Study Protocol Development, 3) Validation Study Infrastructure and Services, and 4) EDRN Core Fund Management.
The other two scientific units of the continuing EDRN program are the Biomarker Characterization Centers (BCCs) which will be responsible for a combined and integrated role in biomarker discovery/development and assay development/standardization; and the Clinical Validation Centers (CVCs), which will conduct clinical research on the validation of biomarkers and/or imaging methods and will serve as resource centers for the Network by participating in collaborative biomarker validation studies with EDRN BCCs.
This Notice is released to provide potential applicants with time to consider the requirements for this program, plan an integrated DMCC, and develop the necessary collaborations for the multi-disciplinary, multi-Principal Investigator FOA. Companion notices for the BCCs and the CVCs are NOT-CA-21-050 and NOT-CA-21-051, respectively.
The DMCC FOA is expected to be published in the Spring of 2021 with an expected application due date in late Summer 2021.
The DMCC FOA will utilize the U24 activity code. Details of the planned FOA are provided below.
The DMCC serves as the scientific and organizational hub for the entire EDRN Network. The DMCC must have expertise and capabilities in biostatistics, computational analysis, imaging, modeling, information technology bioinformatics, data management, protocol development, and in coordinating and providing logistical support for meetings and conferences. DMCC will also be expected to evolve, adapt and improve in response to the needs of the EDRN community. It is essential that the DMCC applicants familiarize themselves with the companion FOAs for the other EDRN units with which the DMCC must work: BCC (RFA-CA-21-NNN) and CVC (RFA-CA-21-NNN).
Data science is poised to play a major role in new or improved risk stratification, early detection, and precision prevention strategies. It is desirable that the biomarker discovery/development approach includes data mining or in silico approaches to support and/or complement discovery efforts. It is also encouraged that computational/mathematical data modeling approaches be used to predict the translational efficacy of the proposed biomarkers as this will ensure a greater chance of success in downstream validation phases and reaching the clinic. Inclusion of data modeling can enhance the discovery 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.
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 $7.2 million in FY 2022 and $9 million per year in FY 2023-2026.
One
The proposed U24 application budget will be limited to $6 million (direct cost) of which $4.2 million must be allocated to the restricted Network Core Fund for Year 1 (FY 2022), and to $7.8 million per year (direct cost) of which $6 million per year must be allocated to the restricted Network Core Fund 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
Guillermo Marquez, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7035
Email: marquezg@mail.nih.gov