HEAL Initiative: Early Phase Pain Investigation Clinical Network - Clinical Coordinating Center (U24 Clinical Trial Not Allowed | RFA NS 19 023

Opportunity Information: Apply for RFA NS 19 023

The HEAL Initiative: Early Phase Pain Investigation Clinical Network - Clinical Coordinating Center (CCC) funding opportunity (RFA-NS-19-023) is a National Institutes of Health (NIH) cooperative agreement (U24) intended to stand up and run the central coordinating “engine” for a national pain research network called EPPIC-Net. EPPIC-Net is positioned as a key piece of the NIH Helping to End Addiction Long-term (HEAL) Partnership, with the broader goal of accelerating the development of safer, more effective treatments for pain and reducing reliance on opioids. The focus of the network is early phase, patient-centered pain research that can move efficiently from identifying the right patient subgroups and biological signals to testing promising treatments in well-executed Phase 2 studies.

At the heart of this program is the idea that pain is not a single condition, and that progress depends on studying carefully defined pain populations with significant unmet medical need. EPPIC-Net is designed to provide a ready-to-use national infrastructure that supports deep clinical phenotyping (detailed characterization of patients, symptoms, function, comorbidities, and other clinically meaningful features) and biomarker work (measures that may help identify mechanisms of pain, classify patients into more precise subgroups, or predict treatment response). With that foundation, the network is also meant to rapidly design and implement high-quality Phase 2 clinical studies to evaluate novel therapeutics, including candidates coming from academic investigators, industry partners, the HEAL Partnership itself, or other NIH initiatives.

Structurally, EPPIC-Net is made up of three major components: a single Clinical Coordinating Center (the subject of this FOA), a single Data Coordinating Center (DCC, solicited under a separate FOA), and roughly 10 specialized clinical centers referred to as Hubs (also solicited under a separate FOA). The CCC is intended to function as the operational and scientific coordination hub for the network’s clinical activities. In practical terms, the CCC is expected to help shape study concepts into workable protocols, coordinate across multiple clinical sites, and facilitate smooth study execution so that trials and related studies can be launched quickly and conducted consistently across the network. While the DCC is responsible for the core data management and related analytics infrastructure, and the Hubs provide the patient access and disease-area expertise, the CCC is the place where the moving parts come together on the clinical operations side so that studies run on time, on budget, and to high quality standards.

The award mechanism is a cooperative agreement, which generally means NIH is expected to have substantial programmatic involvement rather than acting only as a passive funder. That fits the network model described here: NIH is building a coordinated national platform that can run multiple studies over time, not just funding a single stand-alone project. The FOA indicates that the CCC will “help design and facilitate the implementation” of clinical trials and studies, reflecting a hands-on role in organizing and enabling network research rather than simply conducting independent research in isolation.

Although the title includes “Clinical Trial Not Allowed” for the U24 application itself, the purpose of the network explicitly includes supporting and conducting Phase 2 clinical trials through EPPIC-Net once the infrastructure is in place. In other words, the CCC award is for creating and operating the coordinating infrastructure and functions; the actual interventional trials are expected to be run through the network structure and may be supported through HEAL or other NIH pathways, consistent with how large NIH clinical research networks are typically organized.

Eligibility is broad and includes many common applicant types that can credibly operate a national coordinating center. Eligible applicants listed include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; tribal governments and tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other entities as described in NIH’s additional eligibility information. The sponsoring agency is the Department of Health and Human Services (HHS), National Institutes of Health. The opportunity was created on December 10, 2018, with an original closing date of February 6, 2019. The posting indicates an expected number of awards of one, consistent with the plan to fund a single CCC for the entire network, and lists an award ceiling of 0, which typically signals that a fixed maximum was not specified in that field rather than implying no funding.

In short, this FOA funds the centralized Clinical Coordinating Center that makes EPPIC-Net workable as a national platform. The CCC is expected to enable efficient multi-site early phase pain research by coordinating protocol development and study implementation across specialized clinical hubs, in close alignment with NIH’s HEAL priorities. The end goal is a faster, more reliable path from understanding pain subtypes and biomarkers to running rigorous Phase 2 tests of promising non-addictive pain therapeutics in the patient populations that most need better options.

• The Department of Health and Human Services, 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 - Clinical Coordinating Center (U24 Clinical Trial 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, 93.361, 93.393, 93.846, 93.847, 93.853, 93.867, 93.879.
• This funding opportunity was created on Dec 10, 2018.
• Applicants must submit their applications by Feb 06, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 1 candidate(s).
• 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 (see text field entitled Additional Information on Eligibility for clarification).

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