Alcoholic Hepatitis Clinical and Translational Network Clinical Pilot Trials (U01) | RFA AA 18 005

Opportunity Information: Apply for RFA AA 18 005

The Alcoholic Hepatitis Clinical and Translational Network Clinical Pilot Trials (U01) opportunity (RFA-AA-18-005) is a National Institutes of Health funding announcement from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) focused on speeding up progress in alcoholic hepatitis (AH). The core purpose is to build on and continue a previously funded translational research program so that new diagnostic tools and treatment options for AH can be discovered, refined, and validated more quickly. Rather than funding isolated projects with limited coordination, NIAAA is using this announcement as part of a broader, integrated effort designed to move promising ideas from early translational work into well-designed clinical testing in patients.

This U01 is one piece of a larger set of five related funding opportunities intended to consolidate existing work into a single, more coordinated Alcoholic Hepatitis Clinical and Translational Network (the “AH Network”). The network concept is meant to connect multiple functions that are often separated: a clinical component that can enroll and study patients, a Data Coordinating Center to support high-quality data collection and harmonization, a translational component that helps bridge patient-based findings with mechanistic and biomarker work, and a basic/pre-clinical component to support foundational studies that can generate and refine candidate interventions. In practical terms, NIAAA is trying to create a pipeline where clinical observations, biospecimens, and outcome data can inform lab and translational work, and where pre-clinical discoveries can be positioned for patient testing with fewer delays.

Within that network framework, this particular FOA emphasizes investigator-initiated, single-center feasibility and pilot studies in patients with alcoholic hepatitis. The intent is not to immediately launch large, definitive multi-site efficacy trials. Instead, the focus is on the “critical elements” that often determine whether a full-scale trial will succeed: confirming that enrollment and retention are realistic in this population, testing recruitment and consent approaches, refining inclusion and exclusion criteria, standardizing outcome measures, confirming the practicality of intervention delivery, evaluating safety monitoring procedures, validating candidate biomarkers or diagnostic approaches in a clinical workflow, and troubleshooting data capture and protocol adherence. The expectation is that awardees will generate high-confidence preliminary data and operational lessons that can be used to design strong, scalable trials across the broader AH Network.

The funding mechanism is a U01 Research Project Cooperative Agreement, which signals that this is a collaborative model rather than a hands-off research grant. Under cooperative agreements, NIH program staff typically have substantial scientific and/or programmatic involvement, which aligns with the network-building goal and the need for harmonized approaches across studies. This matters for applicants because projects are expected to fit into a coordinated ecosystem, share data and practices in network-aligned ways, and contribute to the larger goal of accelerating AH clinical translation, not just answering a narrow standalone research question.

Eligibility is broad and includes many common U.S.-based applicant types: state, county, and local governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses); and small businesses, among others. The FOA also calls out a range of institutions and organizations that are explicitly welcome as eligible applicants, such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, there are clear limits on foreign participation: non-domestic (non-U.S.) entities and non-U.S. institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, “foreign components” as defined in the NIH Grants Policy Statement are allowed, meaning an otherwise eligible U.S. applicant can include certain defined international elements if they meet NIH policy requirements and are appropriately justified.

Administratively, the opportunity is categorized as discretionary funding, uses the cooperative agreement instrument, and falls under the health activity category with CFDA number 93.273. The record lists an original closing date of October 23, 2017, and an expected nine awards. An award ceiling is not specified in the provided data, which typically means applicants would need to rely on the full FOA text (or related NIH budget guidance) for any caps or expectations on direct costs, project period, and related budgeting constraints.

Overall, the program is best understood as an effort to strengthen the early clinical trial pathway in alcoholic hepatitis by funding practical, patient-centered pilot work that makes later definitive trials more feasible, safer, and more informative. The value proposition for NIAAA is that by supporting tightly designed feasibility studies within a coordinated network structure, the field can reduce trial failures due to avoidable operational issues, standardize data and outcomes across studies, and accelerate movement toward validated diagnostics and effective therapies for a serious and high-mortality liver disease.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Alcoholic Hepatitis Clinical and Translational Network Clinical Pilot Trials (U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273.
• This funding opportunity was created on 2017-08-23.
• Applicants must submit their applications by 2017-10-23. (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 9 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.

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