HEAL Initiative: Early Phase Pain Investigation Clinical Network - Data Coordinating Center (U24 Clinical Trials Not Allowed) | RFA NS 19 024

Opportunity Information: Apply for RFA NS 19 024

This funding opportunity, titled "HEAL Initiative: Early Phase Pain Investigation Clinical Network - Data Coordinating Center (U24 Clinical Trials Not Allowed)" (RFA-NS-19-024), is an NIH cooperative agreement meant to stand up and run the Data Coordinating Center (DCC) for EPPIC-Net, the Early Phase Pain Investigation Clinical Network. EPPIC-Net is positioned as a central piece of the NIH Helping to End Addiction Long-term (HEAL) Partnership, with the broader goal of speeding up the development and testing of non-addictive pain treatments. The network is built to support rigorous early-phase pain research by creating an infrastructure that can quickly move from careful patient characterization to well-designed Phase 2 studies of promising therapies coming from academic or industry partners, especially in pain conditions where current options are limited or inadequate.

EPPIC-Net is organized as a multi-site national research network with three main parts: one Clinical Coordinating Center (CCC), one Data Coordinating Center (the focus of this FOA), and roughly 10 specialized clinical centers or hubs. The hubs are where participants are recruited and studied, the CCC coordinates operational and clinical trial execution across the network, and the DCC serves as the backbone for data and analytics. Although EPPIC-Net is intended to enable Phase 2 clinical trials, this particular award mechanism is explicitly for a DCC under a U24 cooperative agreement and is labeled "Clinical Trials Not Allowed," meaning the applicant is not being funded to run its own independent clinical trial as the prime activity. Instead, the DCC is funded to provide the core data infrastructure and coordinating functions that make the network's trials and studies feasible, consistent, and high quality.

The DCC role described here is unusually broad because it is framed as the main data manager for pain research within the HEAL Initiative. In practical terms, the DCC is expected to host and manage multiple complex data types generated across EPPIC-Net and related HEAL pain research efforts. That includes traditional clinical study data, neuroimaging data, biomarker and biospecimen-related data, omics datasets, and even preclinical data. Because these data types differ in formats, standards, storage needs, and quality control requirements, the DCC is expected to provide the systems and processes to collect, clean, harmonize, document, and curate them so they can be analyzed within individual studies and compared or pooled across studies when appropriate.

A major emphasis of the FOA is that the DCC is not just a repository. It is expected to provide leadership for the statistical design and analysis of EPPIC-Net studies, which typically includes things like developing analysis plans, advising on endpoint selection, powering and sample size assumptions, randomization strategies (when trials occur through the network), interim monitoring approaches, and handling complex multimodal datasets. Alongside statistical leadership, the DCC is responsible for setting up the operational "plumbing" of data flow: electronic data capture and data submission tools, data dictionaries and common data elements where feasible, validation rules, audit trails, and workflows for query resolution and data lock. Quality assurance and reporting are also core expectations, which generally translates into routine data quality checks, consistency reports across sites, performance metrics, and standardized reporting to NIH and network leadership.

Another defining feature of this opportunity is the commitment to sharing. The FOA states that the DCC will make EPPIC-Net data and clinical biosamples available to the wider research community to accelerate pain science. That implies the DCC must support controlled access, de-identification and privacy protections, robust metadata and documentation, governance for data and sample requests, and processes that let external researchers understand and reuse the data without being embedded in the original study team. The DCC therefore functions as both an internal coordinating unit for network studies and an outward-facing platform that enables broader scientific reuse of HEAL pain research assets.

This DCC solicitation is one part of a coordinated set of NIH announcements, with separate FOAs issued for the Clinical Coordinating Center (RFA-NS-18-036) and the Specialized Clinical Centers/hubs (RFA-NS-18-037). Trials carried out through EPPIC-Net can originate from HEAL Initiative efforts or from other NIH funding announcements, so the DCC has to be ready to support studies that may differ in design, therapeutic area, and data complexity while still enforcing consistent standards. Because this is a cooperative agreement, NIH is expected to have substantial involvement in the program, and awardees typically operate in close partnership with NIH staff and the rest of the network.

In terms of eligibility, the FOA is open to a wide range of U.S.-based organizations, including state, county, and local governments; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and various tribal and housing authorities. The announcement also calls out categories such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, faith-based or community-based organizations, and U.S. territories or possessions. At the same time, it clearly excludes non-domestic entities and foreign components: non-U.S. institutions cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.

Key administrative details included in the source information are that the sponsoring agency is the National Institutes of Health, the funding instrument is a cooperative agreement (U24), and the original closing date listed was February 6, 2019, with the FOA created on December 10, 2018. The CFDA numbers referenced span multiple NIH institutes or programs (93.121, 93.213, 93.279, 93.393, 93.847, 93.853, 93.867), reflecting the cross-cutting nature of the HEAL pain research effort. Overall, the opportunity is aimed at building a high-capacity, technically sophisticated coordinating center that can manage and share complex pain-related datasets at scale while providing the statistical and data-operations leadership needed for efficient, high-quality early-phase clinical research within EPPIC-Net.

• The National Institutes of Health in the education, food and nutrition, health sector is offering a public funding opportunity titled "HEAL Initiative: Early Phase Pain Investigation Clinical Network - Data Coordinating Center (U24 Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.213, 93.279, 93.393, 93.847, 93.853, 93.867.
• This funding opportunity was created on 2018-12-10.
• Applicants must submit their applications by 2019-02-06. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA NS 19 024

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: