Translational and Basic Science Research in Early Lesions (TBEL) Coordinating and Data Management Center (U24 Clinical Trial Not Allowed) | RFA CA 21 055

FAQs: Translational and Basic Science Research in Early Lesions (TBEL) Coordinating and Data Management Center (CDMC) - NIH U24 (Clinical Trial Not Allowed)

1) What is this grant opportunity?

This opportunity funds a Coordinating and Data Management Center (CDMC) for the Translational and Basic Science Research in Early Lesions (TBEL) consortium. It is an NIH cooperative agreement using the U24 activity code, and the funding notice specifies that clinical trials are not allowed.

2) What is the purpose of the TBEL program overall?

TBEL is designed to strengthen the link between basic discovery science and translational cancer research focused on precancers and early cancers. The program aims to help investigators test cause-and-effect relationships that drive the earliest steps of cancer development.

3) What scientific perspective does TBEL emphasize about early lesions?

The program emphasizes that tumor initiation and early progression are shaped not only by the lesion itself, but by ongoing interactions among the early lesion, its surrounding microenvironment, and systemic host influences. Examples of host influences mentioned include immune, metabolic, hormonal, inflammatory, and other organism-level factors.

4) What is the long-term aim of TBEL?

The long-term aim is to clarify which mechanisms push early lesions toward malignancy and which mechanisms restrain or suppress that trajectory. The ultimate goal is to enable prevention strategies that are grounded in biology and can be tailored more precisely to risk and context.

5) What is the CDMC's role within TBEL?

The CDMC is described as the operational backbone for the TBEL consortium, not a stand-alone research center. Its job is to provide infrastructure and coordination so that the broader consortium can function as an integrated network.

6) What are the three major responsibilities expected of the CDMC?

The CDMC is expected to take on three major responsibilities across participating projects and sites:

• Consortium-wide coordination: coordinate recurring meetings, conferences, and cross-consortium collaborations to keep centers aligned on goals, methods, milestones, and joint opportunities.
• Statistical and computational analysis support: support harmonized analytic approaches, advise on study design and power considerations where relevant, support reproducible computational workflows, and help ensure analytic outputs are comparable across sites.
• Program data hub operations: establish and run a data hub supporting data capture, curation, management, and protocol development and registration.

7) What does "consortium-wide coordination" include?

Coordination includes recurring meetings, conferences, and other cross-consortium collaborations intended to keep multiple centers aligned on shared goals, methods, milestones, and opportunities for joint work.

8) What types of analytics support is the CDMC expected to provide?

The CDMC is expected to provide statistical and computational support that typically includes harmonizing analytic approaches, advising on study design and power considerations (where relevant to the consortium's work), supporting reproducible computational workflows, and ensuring analytic outputs are comparable across contributing sites.

9) What is meant by a "program data hub" in this opportunity?

The program data hub is expected to support standardized data intake, metadata and quality control, secure storage and controlled access where needed, consistent data dictionaries/ontologies, and the documentation necessary for reuse, sharing, and coordinated analyses.

10) Does the CDMC handle protocol development and registration?

Yes. The CDMC is expected to support protocol development and registration as part of operating the program data hub. The notice indicates the consortium is expected to work with well-defined, trackable study protocols.

11) How can protocol registration fit if clinical trials are not allowed?

The notice signals that protocols should be well-defined and trackable even though the U24 funding opportunity specifies that clinical trials are not allowed. In other words, protocol rigor and registration are still expected for the consortium's studies and activities, within the boundaries of what is allowable under the FOA.

12) How does the CDMC relate to the TBEL U54 Centers?

TBEL is described as a two-part ecosystem: (1) the CDMC (U24), and (2) TBEL U54 Centers. The U54 Centers are intended to be the primary scientific engines conducting the main scientific projects, while the CDMC enables those projects to function as a coherent network through shared operational standards, centralized data practices, and consistent analytic support.

13) Is this opportunity limited to a specific cancer type, organ site, or precancer?

No. A notable feature is that it is not limited to any specific precancer, early lesion, organ site, or cancer type. The program is open to a broad set of approaches unified by early lesion biology and interactions among lesion, microenvironment, and systemic host factors.

14) What is the award mechanism and what does it imply?

The mechanism is a cooperative agreement. This means NIH is expected to have substantial programmatic involvement compared with a standard research project grant.

15) What is the funding opportunity number and NIH identifier information provided?

The Funding Opportunity Number is RFA-CA-21-055. The opportunity is listed under NIH with CFDA numbers 93.394 and 93.396.

16) Are clinical trials allowed under this U24?

No. The notice states the mechanism is a U24 and that clinical trials are not allowed.

17) Who is eligible to apply?

Eligibility is described as broad and includes many U.S.-based organization types commonly eligible for NIH programs. Examples listed include state, county, city/township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; federally recognized Native American tribal governments; other tribal organizations; public housing/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses, along with other categories NIH sometimes includes.

18) Are specific community- or mission-focused institution types explicitly included?

Yes. The notice explicitly includes categories such as HBCUs, Hispanic-serving institutions, AANAPISISs, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, eligible federal agencies, faith-based or community-based organizations, and U.S. territories or possessions.

19) Are foreign organizations eligible to apply?

No. The notice explicitly restricts foreign participation: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply.

20) Are non-U.S. components of U.S. organizations allowed?

No. The notice states that non-U.S. components of U.S. organizations are not eligible.

21) Are foreign components allowed under NIH policy for this opportunity?

No. The notice states that foreign components, as defined by NIH policy, are not allowed.

22) Why do the foreign restrictions matter for the CDMC?

Based on the notice, these constraints align with an expectation that the coordinating infrastructure, data hub, and consortium operations remain fully within allowable U.S.-based institutional boundaries.

23) What key operational expectations should an applicant anticipate for a strong CDMC application?

While no award ceiling or number of awards is specified in the provided text, the described scope implies applicants should be prepared to propose a significant infrastructure-oriented plan. The notice highlights needs such as clear governance, data standards, and service models that can support multiple U54 Centers and other consortium participants across the project period.

24) Does the provided information state the award ceiling or expected number of awards?

No. The provided text indicates that an award ceiling and expected number of awards are not specified.

25) What timeline details are provided for publication and application?

The notice indicates it was issued to give prospective applicants lead time. It states the full funding opportunity announcement was expected to be published in May 2021, with an anticipated application due date in October 2021.

26) What is the original closing date listed?

The original closing date provided is 2021-11-02.

27) Is there mention of a pre-application webinar?

Yes. A pre-application webinar was planned, with details to be posted after FOA publication.

28) Is there a companion opportunity related to the TBEL U54 Centers?

Yes. The notice references a companion notice for the related U54 Centers as NOT-CA-21-XXX, indicating applicants interested in the research-center component should track the parallel announcement.

29) What kind of work does the U54 Centers component do versus the CDMC?

The U54 Centers conduct the main scientific projects intended to bridge gaps between basic and translational research on early lesions and their microenvironments. The CDMC supports those projects by creating shared operational standards, centralized data practices, and consistent analytic support so results can be integrated rather than remaining siloed.

30) What is the practical meaning of "standardized data intake" and "data dictionaries/ontologies" here?

In practical terms, the notice implies the CDMC should build processes and systems for consistent data capture and intake, establish metadata and quality control steps, maintain data dictionaries and/or ontologies so different sites describe data in consistent ways, and provide documentation to support reuse, sharing, and coordinated analysis across the consortium.