Transplantation Statistical and Clinical Coordinating Center (T-SCCC) (U01 Clinical Trial Not Allowed) | RFA AI 22 057

Opportunity Information: Apply for RFA AI 22 057

The National Institutes of Health (NIH), through the National Institute of Allergy and Infectious Diseases (NIAID), released this funding opportunity (RFA-AI-22-057) to establish a Transplantation Statistical and Clinical Coordinating Center (T-SCCC). The award mechanism is a U01 cooperative agreement, meaning the funded organization is expected to work in close collaboration with NIH staff and other program partners rather than operating entirely independently. Although the notice is labeled "Clinical Trial Not Allowed" for the T-SCCC award itself, the center is explicitly designed to support NIAID transplantation research that can include clinical trials and other human studies conducted under related programs. The application due date listed for this opportunity was November 30, 2022.

At its core, the T-SCCC is meant to serve as a central, specialized resource that strengthens how transplantation studies are designed, run, and analyzed across multiple NIAID-supported transplantation efforts. The emphasis is on providing the technical and operational backbone that individual study teams often struggle to build on their own, especially when studies are complex, multi-site, or require consistent methods across projects. Rather than funding a single scientific hypothesis, this opportunity funds infrastructure and expertise that can be applied across a portfolio of transplantation research activities.

A major responsibility of the T-SCCC is statistical and study design support. This includes helping investigators plan rigorous studies from the beginning by advising on endpoints, sample size and power calculations, randomization approaches when relevant, interim analysis considerations, and analytic strategies that match the scientific questions and real-world constraints of transplantation research. The center is also expected to assist with protocol development, which typically covers shaping the study schema, defining inclusion and exclusion criteria, building analysis plans, aligning data collection with endpoints, and helping ensure studies are feasible, consistent, and interpretable. After studies are completed, the T-SCCC is expected to contribute to the final analysis of study findings, helping teams produce credible results that can withstand peer review and inform future transplantation practice and research.

In addition to design and analysis, the T-SCCC has a substantial role in supporting mechanistic and translational components of transplantation studies, particularly around biospecimens. The opportunity calls for capabilities such as biospecimen labeling, shipping logistics, specimen tracking, and providing standardized kits and/or bulk supplies for specimen collection. This kind of centralized biospecimen support is meant to reduce variability across sites, improve chain-of-custody and documentation, and protect specimen integrity, all of which are critical when studies rely on immune monitoring, biomarker discovery, or other laboratory-based readouts tied to clinical outcomes.

The T-SCCC is also expected to coordinate closely with a separate entity, the Clinical Data and Safety and Monitoring Center (CDSMC). In this structure, the CDSMC is identified as the group responsible for data management for transplantation clinical trials, while the T-SCCC focuses on statistical/clinical coordination and biospecimen-related logistics for mechanistic work. The intent is a collaborative division of labor, where study execution benefits from aligned processes: high-quality data capture and safety monitoring on one side, and strong statistical/protocol support plus specimen operations on the other. This arrangement is designed to avoid gaps or duplication and to keep multi-program transplantation research operating under consistent standards.

The types of research the T-SCCC is intended to support are broad within the transplantation space. The announcement explicitly includes support for clinical trials, integrated studies of underlying mechanisms, and other clinical studies such as longitudinal cohorts and genetic studies. It also highlights studies aimed at identifying and validating surrogate endpoints and biomarkers. In practical terms, this means the coordinating center needs to be prepared to support both interventional and observational designs, accommodate complex endpoints (for example, graft survival, rejection phenotypes, infection outcomes, immune reconstitution measures), and manage the analytical challenges common in transplantation research (such as competing risks, time-to-event analyses, longitudinal immune measures, and heterogeneity across patient subgroups and transplant types).

Eligibility is wide and includes many U.S.-based organizational categories commonly permitted under NIH grants. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (excluding institutions of higher education when specified in the eligibility listing); for-profit organizations other than small businesses; and small businesses. The opportunity also calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, historically Black colleges and universities (HBCUs), tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Foreign eligibility is limited in a way that is typical for many NIH coordinating center awards. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as NIH defines them in the NIH Grants Policy Statement, are allowed. This generally means a U.S. applicant organization may include certain foreign collaborations or elements when they are well-justified and compliant, even though the applicant institution itself must be domestic.

Overall, this FOA is about building a centralized, high-capacity coordinating center that improves the quality, consistency, and efficiency of NIAID-supported transplantation research. The funded T-SCCC is expected to function as an expert partner to multiple study teams, helping ensure strong protocols and analyses, reliable biospecimen operations for mechanistic science, and smooth collaboration with the separate data management and safety monitoring infrastructure supporting the transplantation clinical trials portfolio.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Transplantation Statistical and Clinical Coordinating Center (T-SCCC) (U01 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): 93.855.
• This funding opportunity was created on 2022-08-09.
• Applicants must submit their applications by 2022-11-30. (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 AI 22 057

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