Early Detection Research Network Data Management and Coordinating Center and Statistics and Biomarker Resource Center (U24) | Apply Online

Opportunity Summary:

The Early Detection Research Network Data Management and Coordinating Center and Statistics and Biomarker Resource Center (U24) funding opportunity (RFA-CA-09-020) is an NIH cooperative agreement meant to support two core, network-wide resources within the Early Detection Research Network (EDRN). EDRN is a national consortium focused on discovering, developing, and validating biomarkers that can be used for early cancer detection, cancer risk assessment, and the molecular diagnosis and prognosis of early-stage disease. In practical terms, this FOA is not primarily about running a single biomarker project in isolation. It is about building and operating the shared statistical, informatics, and coordination backbone that allows many biomarker studies across the network to be designed well, executed consistently, analyzed rigorously, and communicated effectively.

The FOA splits EDRN statistical and informatics responsibilities between two complementary centers: a Data Management and Coordinating Center (DMCC) and a Statistics and Biomarker Resource Center (SBRC). The DMCC is positioned as the operational hub for network-wide coordination and data infrastructure. Its work includes supporting statistical and computational analysis at the network level, managing data flows and standards, helping develop study protocols, maintaining informatics infrastructure, and organizing EDRN-wide meetings and conferences. The DMCC has four major responsibility areas: (1) Network Coordination, meaning it helps keep the consortium aligned through planning, communication, and coordination of collaborative activities; (2) Data Management and Protocol Development, meaning it supports consistent study documentation, data capture, data quality practices, and protocol harmonization across studies; (3) Theoretical and Applied Statistical Research, reflecting an expectation that the DMCC contributes advanced statistical thinking and methods relevant to biomarker development and validation; and (4) Validation Infrastructure and Services, which points to the systems and support needed to run and support biomarker validation efforts across sites, including the infrastructure that makes multi-site validation feasible and comparable.

The SBRC, by contrast, is framed as a direct statistical support and knowledgebase content resource for EDRN investigators. Its core role is to provide statistical services and consultation for EDRN studies, especially around study design and protocol development for individual projects. That typically implies hands-on input on design choices, power and sample size considerations, analytic plans, and other statistical decisions that determine whether biomarker studies yield reliable, interpretable results. In addition, the SBRC serves as the content management center for the EDRN biomarker knowledgebase, meaning it has responsibility for curating, organizing, and maintaining the information products that capture what biomarkers exist within the network, what evidence supports them, and how they are described and tracked over time.

This FOA sits within a larger EDRN structure that also includes three other major component types: Biomarker Developmental Laboratories (BDLs), Clinical Validation Centers (CVCs), and Biomarker Reference Laboratories (BRLs). Those components are supported through parallel funding announcements (BDLs under a U01 mechanism, CVCs under a U01 mechanism, and BRLs under a U24 mechanism). The DMCC and SBRC are designed to connect and strengthen all of those components by providing shared coordination, statistical guidance, data systems, and knowledge management, rather than duplicating those functions at each site.

From an administrative standpoint, the award mechanism is a U24 cooperative agreement, which signals substantial NIH involvement compared with a standard grant. In cooperative agreements, the funded centers generally work closely with NIH program staff on priorities, milestones, and network needs, which is consistent with the FOA's emphasis on consortium-wide infrastructure, harmonization, and coordinated outputs rather than purely investigator-driven work. The opportunity is categorized as discretionary funding, aligned with health and cancer research activities, and linked to CFDA numbers 93.393 (Cancer Cause and Prevention Research) and 93.394 (Cancer Detection and Diagnosis Research. There is no cost sharing or matching requirement indicated.

Key dates and funding details place this as a time-limited, archived opportunity from 2009: it was posted and created on July 24, 2009, with an original and current closing date of October 29, 2009, and an archive date of November 29, 2009. The estimated total funding listed is $3,000,000, which reflects the scale expected for operating core network resources rather than a small single-lab study. The sponsoring agency is the National Institutes of Health.

Eligibility is broad and includes public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status (with the stated exceptions noted in the eligibility language), for-profit organizations other than small businesses, and small businesses. Additional eligible applicants also include eligible federal government agencies and U.S. territories or possessions. The FOA provides an official NIH link for full details (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-09-020.html) and lists NIH Office of Extramural Research webmaster contacts for access or linking issues.

Overall, the opportunity is best understood as funding for the central nervous system of EDRN's biomarker pipeline: the DMCC runs the coordination, data, infrastructure, and network-level statistical and validation support, while the SBRC provides investigator-facing statistical consulting and manages the biomarker knowledgebase content. Together, these centers are intended to improve consistency, quality, and speed across biomarker discovery-to-validation efforts by making sure the network shares methods, data practices, protocols, and curated knowledge in a coordinated way.

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Next opportunity: Limited Competition Support for Human Specimen Banking in NCI Supported Clinical Trials Cooperative Group Banks (CGB) (U24)

Previous opportunity: The Early Detection Research Network Biomarker Reference Laboratories (U24)

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