Limited Competition for the Continuation of the Childhood Liver Disease Research Network (ChiLDReN) Scientific and Data Coordinating Center (U24 Clinical Trial Optional) | Apply Online

Opportunity Summary:

This funding opportunity, RFA-DK-18-502, is a limited-competition NIH cooperative agreement (U24, clinical trial optional) intended to continue support for the Childhood Liver Disease Research Network (ChiLDReN). The overarching goal is to sustain and strengthen a national research network focused on clinical and translational studies of rare pediatric liver diseases, where individual institutions typically cannot enroll enough patients alone to answer major questions about natural history, outcomes, biomarkers, and potential interventions. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) serves as the NIH sponsor of the network, reflecting a collaborative, hands-on model typical of cooperative agreements in which NIH program staff are actively involved in stewardship and coordination rather than functioning solely as a funder.

ChiLDReN under this announcement is organized as a multi-site consortium made up of a Scientific and Data Coordinating Center (often referred to as the DCC) working in close partnership with participating Clinical Centers (CCs). The DCC is the operational hub responsible for the scientific coordination and the data infrastructure needed to run network-wide studies reliably across many sites. In practical terms, this kind of center typically manages core functions such as protocol coordination, study operations support, data management systems, quality control and assurance, statistical design and analysis, central reporting, regulatory coordination, and facilitation of network governance activities (for example, committees, working groups, investigator meetings, and common standards for data collection). Because the FOA is specifically for continuation of the ChiLDReN Scientific and Data Coordinating Center, it is aimed at maintaining continuity of expertise, systems, and procedures that allow ongoing cohorts and studies to remain consistent over time, which is especially important in rare diseases where longitudinal follow-up is crucial.

The research scope emphasized by the announcement centers on rare liver and cholestatic diseases affecting children. The listed conditions include biliary atresia, Alagille syndrome, alpha-1 antitrypsin deficiency, Progressive Familial Intrahepatic Cholestasis (PFIC) syndromes, bile acid synthesis defects, mitochondrial hepatopathies, idiopathic neonatal hepatitis, cystic fibrosis liver disease, and primary sclerosing cholangitis. By focusing on these disorders, the network is positioned to address shared challenges across diseases that are uncommon, clinically heterogeneous, and often severe, including difficulties in early diagnosis, variable disease trajectories, limited evidence-based treatments, and the need for validated endpoints and biomarkers for future trials. The “clinical and translational” emphasis signals that the work is intended to connect patient-centered clinical observations and outcomes with biologic understanding, including the kinds of biospecimen-linked studies that can clarify mechanisms, refine classification, and support therapeutic development.

From an applicant and eligibility standpoint, the opportunity is categorized under discretionary funding, with the funding instrument being a cooperative agreement. The activity area is health (CFDA 93.847). Eligible applicants include public and state-controlled institutions of higher education, reflecting the expectation that the coordinating center will be housed in a research-intensive academic environment with the capacity to manage complex multi-site operations, sophisticated data systems, and advanced statistical and regulatory support. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, “foreign components,” as defined by the NIH Grants Policy Statement, are allowed, meaning certain elements of the work may involve international collaboration or performance in another country under NIH’s definition and oversight, even though the applicant organization itself must be U.S.-based and eligible. The FOA directs applicants to consult the full announcement for the detailed definitions and conditions that govern these eligibility distinctions.

Key administrative details provided include the opportunity title, number (RFA-DK-18-502), and the original closing date of November 20, 2018, with a creation date of September 18, 2018. The announcement does not specify an award ceiling or expected number of awards in the excerpt provided, but the limited-competition nature strongly implies a narrow applicant pool, typically tied to existing network infrastructure and the need for continuity in coordinating functions. Overall, the opportunity is designed to keep ChiLDReN functioning as a cohesive, data-driven, multi-center platform capable of advancing evidence and improving outcomes for children with rare liver diseases through coordinated studies, shared methods, and centralized scientific and data management.

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