DoD Breast Cancer, Clinical Research Extension Award | HT9425 23 BCRP CREA2

DoD Breast Cancer, Clinical Research Extension Award (FY23 BCRP CREA) FAQs

1) What is the FY23 BCRP Clinical Research Extension Award (CREA)?

The DoD Breast Cancer, Clinical Research Extension Award (FY23 BCRP CREA; Funding Opportunity Number HT9425 23 BCRP CREA2) is a Department of Defense Breast Cancer Research Program mechanism intended to extend the value of existing breast cancer clinical research. It supports added data collection, longer patient follow-up, and deeper analysis of already collected clinical samples and datasets so prior patient participation yields clearer, clinically useful insights.

2) What problem is this award trying to solve?

The award is designed to prevent the loss of clinically meaningful knowledge that can happen when follow-up ends too early or when samples and datasets are not fully analyzed. The goal is to turn existing clinical research efforts into more complete, actionable findings that can improve outcomes and move the field toward ending breast cancer.

3) What is the central emphasis or defining expectation of this award?

A defining expectation is impact. Proposed work should be positioned to make a major, clinically relevant difference rather than incremental progress. Applications are expected to clearly identify which breast cancer patient groups, or at-risk individuals, are expected to benefit from the findings.

4) What kinds of clinical needs should an application connect to?

Proposals are expected to connect extension work to tangible clinical needs, such as improving risk stratification, refining prognosis, predicting therapy response, understanding recurrence, or informing future standards of care.

5) Does this award support starting a brand-new clinical trial?

No. A key boundary is that the award cannot be used to directly support a clinical trial itself. It funds added analyses, follow-up, and translational work that build on clinical trials and clinical studies that already exist.

6) What types of projects are considered appropriate for this mechanism?

The scope is broad but focused on extension activities. Examples described include deeper molecular profiling of existing clinical specimens, new or expanded correlative studies linked to clinical outcomes, validation of candidate biomarkers, and continued follow-up of participants from an open/ongoing or completed trial.

7) Can projects be hypothesis-driven, or do they need to be purely resource-building?

Both are supported. The mechanism supports work that is hypothesis-driven (including testing or generating hypotheses) as well as work that creates clinically annotated and molecularly characterized resources that can serve as experimental platforms for the wider research community.

8) What kinds of shared resources or platforms does the opportunity mention?

The description notes resources such as patient-derived models or tissue arrays, and emphasizes that outputs like experimental platforms and molecular data generated through the project should be shared with the broader scientific community.

9) What are the feasibility expectations?

Feasibility is treated as a must-have. Applicants are required to present preliminary data supporting both the scientific rationale and the practicality of the approach, and they must show access to the samples, datasets, patient populations, and other resources needed to complete the work.

10) Why is access to samples and datasets so important for this award?

Because this mechanism is specifically about extending and completing what prior clinical research started, reviewers will expect clear evidence that the required materials are available now and that there is a realistic path to completing analyses and follow-up within the award period.

11) Are there expectations around statistical rigor and sample size?

Yes. Applicants need to justify study sample size so results can support valid conclusions and credibly move toward clinical application. The applicant is expected to demonstrate that cohort size, statistical plan, and endpoints match the objectives and will not produce underpowered or ambiguous findings.

12) Is a data-sharing plan required?

Yes. Applicants must provide a plan for sharing experimental platforms and molecular data generated through the project with the broader scientific community, reinforcing the aim of multiplying the impact of prior patient participation.

13) What is the Partnering PI Option?

The Partnering PI Option allows two principal investigators to lead together: an Initiating PI (who handles most submission and administrative responsibilities) and a Partnering PI. It is intended to promote genuine collaborations, especially between basic scientists and clinical researchers.

14) Is the Partnering PI arrangement meant to be symbolic or limited?

No. The announcement emphasizes it is not a token arrangement. Both PIs are expected to contribute substantial and distinct expertise, share meaningful intellectual ownership of the project design, and commit comparable and appropriate effort.

15) How should budgets typically be handled under the Partnering PI Option?

Budgets are generally expected to be balanced between the two PIs unless there is clear justification for an unequal distribution.

16) What should the application explain if using the Partnering PI Option?

The application should explain why the partnership is necessary and why the work cannot be effectively accomplished through separate, disconnected efforts.

17) If recommended for funding, how are awards made under the Partnering PI Option?

If recommended for funding, each PI is named on an individual award within the recipient organization.

18) What does the opportunity say about the research team?

Team strength is emphasized. Applications are expected to assemble a robust team with the combined expertise needed to deliver the proposed extension work, with a clear patient-centered perspective throughout.

19) Is consumer advocate involvement required?

Yes. Consumer advocate involvement is required, not optional.

20) How many consumer advocates are required, and who must they be?

The team must include at least two breast cancer consumer advocates who are breast cancer survivors and active members of a breast cancer advocacy organization.

21) Are there independence requirements for consumer advocates?

Yes. Their role must be independent; they cannot be employees of the participating organizations.

22) What is the intended role of consumer advocates in the project?

Their role should be clearly described in both study design and execution. The intent is for advocates to provide objective, informed input that helps keep the work aligned with patient priorities and real-world impact for people living with breast cancer or those at increased risk.

23) Which agency and office administer this opportunity?

This opportunity is offered by the Department of Defense, Department of the Army, via USAMRAA.

24) What is the CFDA number associated with this opportunity?

The listing identifies CFDA 12.420.

25) What types of funding instruments are used?

The funding instrument types include grants and cooperative agreements.

26) What is the general eligibility description in the listing?

Eligibility is described as unrestricted (open to any type of entity), subject to any additional eligibility language in the full notice.

27) When was the FY23 opportunity posted and when did it close (as listed)?

For the FY23 cycle referenced, it was posted on February 6, 2023, with an original closing date of April 11, 2023.

28) How many awards were anticipated for this listing?

The listing anticipated approximately two awards.

29) What is the award ceiling for this opportunity?

The posted award ceiling is shown as 0, which typically indicates applicants must consult the full program announcement for budget limits or that ceilings may be determined by other guidance rather than a single fixed cap in the listing.

30) In one sentence, what is this mechanism best suited for?

It is best suited for "finishing strong" by extending follow-up and performing additional analyses and translational validation on existing clinical research, samples, and datasets to produce more definitive, clinically meaningful conclusions.