Data Coordinating and Operations Center for the ECHO IDeA States Pediatric Clinical Trials Network - 3 (U24 Clinical Trial RequiredInfrastructure)

Background
This Notice of Funding Opportunity (NOFO), issued by the Office of the Director (OD), National Institutes of Health (NIH), invites applications from entities/institutions in Institutional Development Award (IDeA)-eligible states to participate as the Data Coordinating and Operations Center (DCOC) in the Environmental influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN). The ECHO ISPCTN is the intervention component of the ECHO Program and supports its overall mission to enhance the health of children for generations to come. The DCOC award budget will fund approximately five multicenter pediatric clinical trials with each trial related to prevention or treatment of one or more of ECHOs five outcome areas of interest: pre-, peri-, and postnatal outcomes; upper and lower airways; obesity; neurodevelopment; and positive health. Overall, the five trials should address at least two of the five areas.

Grant Details
The Data Coordinating and Operations Center (DCOC) will support the ECHO ISPCTN Clinical Sites to develop, conduct, and disseminate findings from multicenter clinical trials research, assuring the participation of children living in rural or underserved communities in IDeA states. It will also build pediatric clinical trial research capacity in IDeA states funded by the ECHO ISPCTN and engage interested parties such as community members, nonprofit organizations, and professional societies to enhance ECHO ISPCTN clinical trial impact, transferability, rigor, and feasibility. The DCOC will provide support for research projects initiated by the ECHO ISPCTN Clinical Sites including assistance with developing protocols for multicenter clinical trials, establishing processes for clinical site protocol development with Steering Committee review, providing regulatory sponsorship of clinical trials conducted under an investigational new drug (IND) or investigational device exemption (IDE), assisting investigators with developing study budgets, overseeing and coordinating multicenter clinical trials including establishing subcontracts with participating clinical sites and disbursing trial-specific funds to sites.

Eligibility Requirements
Only institutions or organizations in IDeA-eligible states/commonwealth are eligible to respond to this NOFO. Eligible applicants include higher education institutions, nonprofits other than institutions of higher education, for-profit organizations, local governments, state governments, county governments, city or township governments, special district governments, Indian/Native American tribal governments (federally recognized), Indian/Native American tribal governments (other than federally recognized), federal governments.

Period of Performance
The award project period is 5 years.

Grant Value
Applicants may request a budget up to $1,750,000 per year in direct costs for Core Infrastructure Costs for the DCOC's roles in supporting general ECHO ISPCTN operations. In addition, applicants should budget $3,500,000 per year in direct costs for Protocol-Specific Costs for distribution to the ECHO ISPCTN Clinical Sites as capitation fees to conduct clinical trials. NIH intends to fund an estimate of 1 award corresponding to a total of $8 million for fiscal year 2025.

Place of Performance
Entities/institutions in Institutional Development Award (IDeA)-eligible states are eligible to participate as the Data Coordinating and Operations Center (DCOC) in the Environmental influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network.