PDX Data Commons and Coordinating Center (PDCCC) for the PDX Development and Trial Centers Research Network (PDXNet) (U24 Clinical Trial Not Allowed) | RFA CA 22 013

Frequently Asked Questions (FAQ) - RFA-CA-22-013 (PDX Data Commons and Coordinating Center)

What is RFA-CA-22-013?

RFA-CA-22-013 is a National Institutes of Health (NIH), National Cancer Institute (NCI) funding opportunity to support a single PDX Data Commons and Coordinating Center (PDCCC) under a cooperative agreement mechanism (U24). The PDCCC is intended to serve as the central coordination, data management, and data analysis hub for the PDX Development and Trial Centers Research Network (PDXNet).

What is the overall goal of this funding opportunity?

The goal is to establish the informatics and coordination backbone for PDXNet so that preclinical patient-derived xenograft (PDX) studies performed across multiple centers can use shared standards, be captured in a common data ecosystem, be analyzed consistently, and be translated into clear evidence that supports translational prioritization of targeted therapies and combinations.

What does "PDCCC" stand for, and what is it expected to do?

PDCCC stands for PDX Data Commons and Coordinating Center. It is expected to function as the central hub for cross-network coordination, consistent data capture and harmonization, and integrated analytics so results can be compared and combined across studies, sites, diseases, and therapeutic hypotheses.

How does PDCCC relate to PDXNet?

PDXNet is an NCI program focused on large-scale, collaborative development and preclinical testing of targeted cancer therapies using patient-derived models, with the broader aim of advancing precision medicine. The PDCCC is intended to make PDXNet operate as a unified network rather than a set of separate projects by coordinating activities and enabling shared data and analysis.

Is this funding opportunity for a clinical trial?

No. A key point of this funding opportunity is that it is not a clinical trial mechanism. The work supported is intended to focus on preclinical model development, study coordination, and translational prioritization rather than running clinical intervention studies under this award.

What is the NIH funding mechanism used for this opportunity?

This opportunity uses a cooperative agreement mechanism (U24). Under a cooperative agreement, NIH/NCI has substantial programmatic involvement compared with a typical research project grant, and applicants should expect active coordination with NIH program staff and structured network governance, deliverables, and timelines typical of a center-style award.

How many awards are expected under this announcement?

This announcement is intended to fund a single PDCCC. The broader network is envisioned to include up to five PDX Development and Trial Centers (PDTCs) funded through a companion funding opportunity, plus one PDCCC funded under this announcement.

What are PDTCs, and how are they different from the PDCCC?

PDTCs (PDX Development and Trial Centers) generate and test PDX models and produce preclinical evidence on responses to single agents and drug combinations. They also create new models that fill gaps in publicly available resources and improve methods and metrics for in vivo testing. The PDCCC does not replace PDTC scientific work; it coordinates the network and provides shared data management, harmonization, and cross-network analytics so findings are interpretable and comparable across centers.

What is the companion FOA for the PDTCs?

The companion funding opportunity for the PDX Development and Trial Centers (PDTCs) is RFA-CA-22-012.

Why is a centralized data commons and coordinating center important for PDXNet?

PDXNet involves multiple centers generating models and preclinical results. The PDCCC is designed to support standardized descriptions of models, treatments, response endpoints, experimental designs, and quality metrics so that results can be compared and combined across different studies and sites, and so that the outputs are actionable beyond the originating lab.

What kinds of standardization does the FOA emphasize?

The FOA emphasizes standardized ways of describing PDX models, treatments, response endpoints, experimental designs, and quality metrics to ensure preclinical findings are interpretable, reproducible, and useful for translational decision-making across the network.

How is this effort connected to translational decision-making?

A major motivation is to make PDXNet outputs directly useful for translational prioritization, especially for therapeutic combinations involving agents in the NCI Investigational New Drugs (NCI-IND) portfolio. The PDCCC-supported data commons and analyses are meant to strengthen the evidence base used to determine which combinations are most promising to advance toward clinical evaluation.

What is the NCI-IND portfolio, as referenced in the opportunity?

The NCI-IND portfolio refers to agents in the NCI Investigational New Drugs portfolio. The opportunity highlights prioritizing therapeutic combinations involving these agents as a key translational use case for PDXNet outputs.

How does ETCTN relate to this program?

Agents in the NCI-IND portfolio are evaluated clinically through the NCI Experimental Therapeutic Clinical Trials Network (ETCTN). While this award is not for clinical trials, the PDCCC-enabled preclinical evidence and cross-network analyses are intended to help inform which therapeutic combinations should be prioritized for downstream clinical evaluation in ETCTN.

What is the relationship between PDCCC/PDXNet and the NCI Patient-Derived Models Repository (PDMR)?

The FOA emphasizes close alignment with the NCI Patient-Derived Models Repository (PDMR) housed at the Frederick National Laboratory for Cancer Research (FNLCR). Both PDTCs and the PDCCC are expected to collaborate with the PDMR on goals such as developing and refining optimized standard operating procedures and facilitating sharing of PDX models.

Where is the PDMR located?

The PDMR is housed at the Frederick National Laboratory for Cancer Research (FNLCR).

What is the purpose of collaborating with the PDMR?

The collaboration is intended to reduce fragmentation in model generation and characterization, improve reproducibility, and ensure that models and associated datasets can be disseminated as a public resource in ways that other researchers can reuse.

What does the PDCCC contribute to reproducibility and reuse?

By supporting consistent data capture, harmonization, and standardized definitions for key elements of preclinical studies (models, treatments, endpoints, designs, and quality metrics), the PDCCC helps make results comparable across sites and more reusable by the broader research community.

What is the activity category and CFDA listing for this opportunity?

The activity category is listed under education and health. The CFDA listing is 93.396.

What was the original closing date listed for the opportunity?

The original closing date shown for the opportunity was 2022-11-01.

Who is eligible to apply?

Eligibility is broad across U.S.-based organization types. Eligible applicants include state, county, and local governments; special districts; public and private institutions of higher education; independent school districts; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education where applicable); for-profit organizations (with categories listed in the FOA, including one category excluding small businesses and another including small businesses); and other entities.

Are institutions serving underrepresented groups explicitly included as eligible applicants?

Yes. The FOA explicitly calls out additional eligible applicant groups such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, AANAPISIS institutions, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Are foreign organizations eligible to apply?

No. Non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply.

Are non-domestic components of U.S. organizations eligible to apply?

No. Non-domestic components of U.S. organizations are not eligible to apply.

Are foreign components allowed at all under this opportunity?

Yes. Foreign components, as NIH defines them in the NIH Grants Policy Statement, are allowed. This typically means discrete elements of the project may be performed outside the U.S. under an otherwise eligible U.S. applicant when well-justified and compliant with NIH policy.

What makes this opportunity different from a typical research project grant?

Because this is a cooperative agreement (U24), NIH/NCI will have substantial programmatic involvement. Applicants should expect active coordination with NIH program staff and structured network governance, along with deliverables and timelines that are typical of a center-style award.

What is meant by the PDCCC being the "glue" of the network?

The PDCCC is described as the "glue" because it is responsible for enabling coordination across centers, supporting consistent and harmonized data capture, and providing integrated analytics that allow studies and results to be compared and combined across the network.

What kinds of outputs is the PDCCC intended to enable?

The PDCCC is intended to enable a common data ecosystem and cross-network analyses that make PDXNet preclinical outputs interpretable and actionable for translational prioritization, including helping identify which NCI-IND agent combinations are most compelling for potential downstream clinical evaluation.