Opportunity Information: Apply for HT9425 23 BCRP CREA2 2
The DoD Breast Cancer Research Program (BCRP) Clinical Research Extension Award (FY23) is designed to get more long-term value out of breast cancer clinical studies that have already been conducted or are currently underway. Instead of funding brand-new clinical trials, this opportunity focuses on extending or expanding what can be learned from existing clinical research by supporting additional data collection, longer patient follow-up, and deeper or more complete analysis of previously gathered samples and information. The main idea is to prevent important knowledge from being lost when trials end early, when follow-up is cut short, or when sample and data collection or analysis was not as complete as it could have been. A central theme in the announcement is respect for patient participation: if patients contributed tissue, blood, or other specimens, and shared their clinical data, the program wants to ensure those contributions translate into the strongest possible scientific and clinical impact.
The work funded under this award must be clearly tied to increasing impact from a previously funded clinical trial or clinical study, either by strengthening the conclusions of that earlier effort or by enabling new, clinically meaningful insights that accelerate progress against breast cancer. The scope is intentionally broad but grounded in real-world clinical research needs. Examples of supported activities include deeper molecular profiling of banked clinical specimens, new correlative science tied to clinical outcomes, validation of biomarkers, and continued follow-up of patients from a completed or ongoing study. The research can be hypothesis-testing (confirming a defined scientific question) or hypothesis-generating (producing signals and patterns that justify future testing). It can also be aimed at creating valuable shared resources, such as clinically annotated datasets, molecularly characterized experimental platforms, patient-derived models, or tissue arrays. Importantly, innovation is explicitly not a review criterion for this mechanism, and proposals that aim to conduct clinical trials are not supported.
Feasibility is treated as a must-have. Applicants are expected to bring preliminary data that supports both the scientific rationale and the practicality of the approach, and they must show they actually have access to the patient populations, specimens, and other resources needed to complete the proposed work. The program also places strong emphasis on rigorous data evaluation. Proposed projects should be built around a sample size that can support valid conclusions or, at minimum, generate a meaningful and defensible hypothesis. Applicants are expected to justify the sample size and describe the statistical methods and key analytical considerations they will use.
Another core requirement is openness and reuse of outputs. The application must include a data sharing plan that explains how the broader research community will be able to access the experimental platforms and the molecular and other datasets produced through the project. In other words, the award is not just meant to produce a single set of findings for one team; it is also meant to generate assets that can support ongoing and future breast cancer research.
The announcement also encourages team science through an optional Partnering PI structure. Under this option, two Principal Investigators can apply together, with one serving as the Initiating PI (handling most submission and administrative tasks) and the other as the Partnering PI. The intent is not a symbolic collaboration; each PI is expected to bring distinct expertise and to contribute equally and substantially to the project design and execution, including the project narrative and statement of work. Budgets are generally expected to be balanced between the two investigators unless a clear justification is provided. The application must also explain why the partnership is essential, how the combined expertise strengthens the research strategy, and why the work should be done jointly rather than as separate efforts. The program discourages investigators from appearing as a PI on multiple applications unless the proposals are clearly addressing different research questions. If selected, each PI is named on an individual award within the recipient organization.
From a staffing and perspective standpoint, applications are expected to be supported by a robust research team with the right breast cancer-relevant expertise to carry out the plan successfully. In addition, consumer advocate involvement is not optional; it is required. The team must include at least two breast cancer consumer advocates who have been diagnosed with breast cancer and who are actively involved in a breast cancer advocacy organization. These advocates must be independent lay representatives (not employees of participating organizations), and the application must clearly describe their role in shaping the study and staying involved through execution. The program expects advocates to have enough knowledge of current breast cancer issues and appropriate background or training in breast cancer research to provide informed, objective input, especially around patient-centered relevance and potential impact for people with breast cancer or those at risk.
Administratively, this is a Department of Defense opportunity managed through the U.S. Army Medical Research Acquisition Activity (USAMRAA). The funding instrument types listed include grants and cooperative agreements, and eligibility is described as unrestricted (open broadly across entity types, subject to any additional eligibility notes in the full notice). The opportunity identifier is HT9425 23 BCRP CREA2 2, it was posted June 28, 2023, and the original closing date was September 26, 2023. The listing indicates an expected single award and shows an award ceiling of 0 in the source record, which typically signals that applicants need to rely on the full funding announcement for the actual allowable budget parameters and limits.Apply for HT9425 23 BCRP CREA2 2
- The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Breast Cancer, Clinical Research Extension Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on Jun 28, 2023.
- Applicants must submit their applications by Sep 26, 2023. (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 1 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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FAQs: DoD Breast Cancer Research Program (BCRP) Clinical Research Extension Award (FY23)
What is the purpose of the BCRP Clinical Research Extension Award (FY23)?
This award is meant to increase the long-term value and impact of breast cancer clinical research that has already been completed or is currently underway. Rather than paying for brand-new clinical trials, it supports work that extends, strengthens, or expands what can be learned from existing clinical studies through added data collection, longer follow-up, and deeper analysis of previously collected samples and information.
Does this funding support brand-new clinical trials?
No. Proposals that aim to conduct clinical trials are not supported under this mechanism. The focus is on extending or expanding the impact of existing or previously funded clinical trials or clinical studies.
What kinds of projects are a good fit for this award?
Projects must be clearly tied to increasing the impact of a previously funded clinical trial or clinical study. Examples described in the opportunity include deeper molecular profiling of banked clinical specimens, new correlative science linked to clinical outcomes, biomarker validation, and continued patient follow-up from a completed or ongoing study.
What problem is this award trying to solve?
The award is designed to prevent important scientific and clinical knowledge from being lost when trials end early, follow-up is cut short, or sample/data collection and analysis were not as complete as they could have been. A stated theme is respect for patient participation and ensuring donated specimens and shared clinical data produce the strongest possible impact.
Is the research required to be hypothesis-testing, or can it be hypothesis-generating?
Both approaches are allowed. The opportunity supports hypothesis-testing research (confirming a defined scientific question) and hypothesis-generating research (producing signals or patterns that justify future testing).
Are resource-building projects allowed?
Yes. The announcement notes that projects can aim to create valuable shared resources such as clinically annotated datasets, molecularly characterized experimental platforms, patient-derived models, or tissue arrays.
Is innovation a required review criterion for this mechanism?
No. Innovation is explicitly not a review criterion for this award mechanism.
What does the program expect regarding feasibility?
Feasibility is treated as a must-have. Applicants are expected to include preliminary data supporting the scientific rationale and the practicality of the approach. They must also demonstrate access to the needed patient populations, specimens, and other resources required to complete the proposed work.
What are the expectations around sample size and statistics?
The program emphasizes rigorous data evaluation. Projects should be built around a sample size that supports valid conclusions or, at minimum, generates a meaningful and defensible hypothesis. Applicants are expected to justify the sample size and describe statistical methods and key analytical considerations.
Is a data sharing plan required?
Yes. The application must include a data sharing plan explaining how the broader research community will be able to access experimental platforms and the molecular and other datasets produced through the project.
Is this award intended to benefit only the applicant team?
No. The announcement stresses openness and reuse of outputs, meaning the award is intended to generate assets (platforms and datasets) that can support ongoing and future breast cancer research beyond a single team.
Can two Principal Investigators apply together?
Yes. The opportunity includes an optional Partnering PI structure where two PIs can apply together: an Initiating PI (who handles most submission and administrative tasks) and a Partnering PI.
What is expected of the Partnering PI arrangement?
The partnership is expected to be substantive, not symbolic. Each PI must bring distinct expertise and contribute equally and substantially to project design and execution, including the project narrative and statement of work.
Do the two PIs need to split the budget evenly?
Budgets are generally expected to be balanced between the two investigators unless there is a clear justification for a different allocation.
What must the application explain if using the Partnering PI option?
The application must explain why the partnership is essential, how the combined expertise strengthens the research strategy, and why the work should be done jointly rather than as separate efforts.
Can an investigator be a PI on multiple applications?
The program discourages investigators from appearing as a PI on multiple applications unless the proposals are clearly addressing different research questions.
If selected under the Partnering PI option, how are the awards issued?
Each PI is named on an individual award within the recipient organization.
What does the opportunity say about the research team?
Applications are expected to be supported by a robust research team with the breast cancer-relevant expertise needed to carry out the plan successfully.
Is consumer advocate involvement required?
Yes. Consumer advocate involvement is required, not optional.
How many consumer advocates are required, and who must they be?
The team must include at least two breast cancer consumer advocates who have been diagnosed with breast cancer and are actively involved in a breast cancer advocacy organization.
Are there independence requirements for the consumer advocates?
Yes. The advocates must be independent lay representatives and cannot be employees of participating organizations.
What should the application include about the consumer advocates?
The application must clearly describe the advocates' role in shaping the study and remaining involved throughout execution. The program expects advocates to have enough knowledge of current breast cancer issues and appropriate background or training in breast cancer research to provide informed, objective input focused on patient-centered relevance and potential impact.
Which agency manages this funding opportunity?
This is a Department of Defense opportunity managed through the U.S. Army Medical Research Acquisition Activity (USAMRAA).
What funding instrument types are associated with this opportunity?
The listing includes grants and cooperative agreements as funding instrument types.
Who is eligible to apply?
Eligibility is described as unrestricted (open broadly across entity types), subject to any additional eligibility notes in the full notice.
What is the opportunity identifier?
The opportunity identifier is HT9425 23 BCRP CREA2 2.
When was this opportunity posted, and what was the original closing date?
It was posted on June 28, 2023, and the original closing date was September 26, 2023.
How many awards are expected?
The listing indicates an expected single award.
What is the award ceiling for this opportunity?
The source record shows an award ceiling of 0, which typically signals that applicants should rely on the full funding announcement for the actual budget parameters and limits.
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