Opportunity Information: Apply for HT942524PRCRPACCCTA

The FY24 DoD Peer Reviewed Cancer Research Program (PRCRP) Advancing Cancer Care Through Clinical Trials Award (ACCCTA) is a Department of the Army (USAMRAA) grant opportunity intended to move cancer interventions into the clinic quickly, with a clear emphasis on near-term, real-world impact. This mechanism is built specifically to fund clinical trials that can meaningfully change how cancer is treated or managed within at least one of the FY24 PRCRP Topic Areas. The program is oriented toward practical clinical progress rather than exploratory lab work, and it is designed to support studies that are ready to enroll patients and generate actionable evidence.

At its core, the ACCCTA funds the rapid implementation of clinical trials testing promising approaches such as new products, drugs or biologics, medical devices, clinical guidance, and emerging technologies. The scope is intentionally broad in terms of trial phase and size: proposals can range from small proof-of-concept studies (including pilot trials, first-in-human efforts, and phase 0 designs) to larger trials aimed at determining efficacy in relevant patient populations. What matters is that the study is a genuine clinical trial and that the proposed intervention has a credible path to changing practice, advancing to the next stage of clinical development, or transitioning results into fielded science. A notable feature of the opportunity is that the award funds must directly support a clinical trial; this is not a mechanism where the trial is optional or a secondary component.

The program also sets an aggressive timeline for execution. The clinical trial is expected to begin within 12 months of the award date, with an allowance up to 18 months for trials that are regulated by a Regulatory Agency (for example, when additional regulatory steps are needed). This requirement signals that applicants should already have much of the foundational planning completed and be positioned to move quickly through study startup activities like site activation, contracting, and approvals.

Impact expectations are specific and mission-driven. The intervention being tested should have strong potential to improve the standard of care or clearly advance clinical development in a way that matters for patients. In addition to aligning with at least one FY24 PRCRP Topic Area, the project must also address one FY24 PRCRP Military Health Focus Area and one FY24 PRCRP Overarching Challenge, reinforcing that relevance to military health priorities is a central consideration. The program also explicitly calls for incorporating quality-of-life and supportive care considerations during the trial, indicating that endpoints and study conduct should reflect patient experience and real-world treatment burdens, not just tumor response or biomarker changes.

A key readiness requirement is the inclusion of supportive preclinical data that justify initiating the proposed clinical trial. The award does not support new preclinical research to build an IND or IDE package, and it prohibits animal work. In other words, the program expects that the evidence needed to rationalize the trial already exists at the time of application, and the proposal should present that data clearly to support safety, biological plausibility, dosing rationale, feasibility, or other elements necessary to ethically and scientifically launch the study.

Feasibility is heavily scrutinized, especially around enrollment. Applicants must show they have access to a suitable patient population and a realistic plan to meet accrual targets in a way that will produce meaningful outcomes. The application should spell out how recruitment will be achieved and should include an inclusion strategy for women and minorities that fits the study objectives. There is a limited exception: studies using human biospecimens or datasets that cannot be linked to an individual or demographic characteristics (often IRB-exempt) are exempt from the women and minority inclusion strategy requirement, because demographic tracking is not possible in those cases.

The opportunity also requires applicants to demonstrate practical access to the intervention itself. Whether the study depends on a drug/compound, device, or other specialized materials, the proposal must document availability and access for the full duration of the trial. This is meant to prevent delays or trial failure due to supply constraints, manufacturing uncertainty, licensing barriers, or lack of agreements with vendors or collaborators.

From an operations standpoint, the DoD expects a team that is already capable of executing a clinical trial to modern standards. The application should demonstrate expertise across clinical trial conduct, statistics, data management, and (when applicable) FDA-related processes. A study coordinator (or coordinators) is expected to manage the clinical protocol through the local IRB of record, handle other federal regulatory approval processes, coordinate multi-site activities when relevant, and actively support participant accrual. The program also looks for strong institutional support and, if the project requires it, a clear commitment and capability to serve as the FDA regulatory sponsor, including fulfilling sponsor responsibilities described in 21 CFR 312, Subpart D.

Finally, the program places strong emphasis on rigorous analytics and clean data infrastructure. Applicants must provide a clear statistical analysis plan, including power and sample size projections that match the study objectives, along with a data management plan that protects data integrity and uses an appropriate database. If a Regulatory Agency requires it, the trial must use a 21 CFR 11-compliant database and appropriate data standards, reflecting expectations for auditability, secure electronic records, and regulatory-grade data quality.

Administratively, this is a discretionary grant (Funding Opportunity Number HT942524PRCRPACCCTA; CFDA 12.420) offered by the Department of the Army through USAMRAA. Eligibility is listed as unrestricted, the original closing date was October 15, 2024, and the agency anticipated making about five awards. While the award ceiling is not specified in the provided text, the overall design of the mechanism makes clear that the DoD is prioritizing trials that are ready to launch, tightly managed, and positioned to deliver clinically meaningful results aligned with PRCRP and military health priorities.

  • The Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Peer Reviewed Cancer, Advancing Cancer Care Through Clinical Trials 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 2024-06-17.
  • Applicants must submit their applications by 2024-10-15. (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 5 candidate(s).
  • Eligible applicants include: Unrestricted.
Apply for HT942524PRCRPACCCTA

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FAQs: FY24 DoD PRCRP Advancing Cancer Care Through Clinical Trials Award (ACCCTA)

What is the ACCCTA funding opportunity?

The FY24 DoD Peer Reviewed Cancer Research Program (PRCRP) Advancing Cancer Care Through Clinical Trials Award (ACCCTA) is a Department of the Army (USAMRAA) discretionary grant opportunity intended to move cancer interventions into the clinic quickly, with a clear emphasis on near-term, real-world impact. It is designed to fund clinical trials that can meaningfully change how cancer is treated or managed within at least one of the FY24 PRCRP Topic Areas.

What is the main purpose of this award mechanism?

The purpose is to rapidly implement clinical trials that test promising cancer interventions and generate actionable evidence that can improve the standard of care, advance the intervention to the next stage of clinical development, or transition results into fielded science.

Does the proposed project have to be a clinical trial?

Yes. Award funds must directly support a clinical trial. This mechanism is not structured for projects where a clinical trial is optional, secondary, or merely a future plan.

What kinds of interventions can be tested under ACCCTA?

The opportunity supports clinical trials testing approaches such as new products, drugs or biologics, medical devices, clinical guidance, and emerging technologies, as long as they are positioned to deliver clinically meaningful impact and fit within the FY24 PRCRP scope described.

Are only late-stage (large) trials supported, or can early-stage trials apply?

The scope is broad. Proposals can range from small proof-of-concept studies (including pilot trials, first-in-human efforts, and phase 0 designs) to larger trials aimed at determining efficacy in relevant patient populations. The key requirement is that the study is a genuine clinical trial with a credible path to changing practice or advancing development.

How quickly is the clinical trial expected to start after award?

The clinical trial is expected to begin within 12 months of the award date. An allowance of up to 18 months is permitted for trials regulated by a Regulatory Agency when additional regulatory steps are needed.

What does the accelerated start timeline imply for applicants?

It implies applicants should already have substantial foundational planning completed and be positioned to move quickly through startup activities such as site activation, contracting, and approvals.

What alignment requirements must the project meet within PRCRP?

The project must align with at least one FY24 PRCRP Topic Area. In addition, it must address one FY24 PRCRP Military Health Focus Area and one FY24 PRCRP Overarching Challenge, reflecting a requirement for relevance to military health priorities.

How does the program define or emphasize "impact"?

Impact expectations are mission-driven and emphasize near-term, real-world clinical progress. The intervention should have strong potential to improve the standard of care or clearly advance clinical development in a way that matters for patients.

Are quality-of-life and supportive care considerations required?

Yes. The opportunity explicitly calls for incorporating quality-of-life and supportive care considerations during the trial, indicating that endpoints and trial conduct should reflect patient experience and real-world treatment burdens, not only clinical response measures.

Is preclinical data required to support the clinical trial?

Yes. Applicants must include supportive preclinical data that justify initiating the proposed clinical trial. The application is expected to present existing evidence clearly to support elements such as safety, biological plausibility, dosing rationale, feasibility, or other essentials needed to ethically and scientifically launch the study.

Can ACCCTA funds be used to perform new preclinical research?

No. The award does not support new preclinical research to build an IND or IDE package.

Is animal work allowed under this opportunity?

No. The opportunity prohibits animal work.

What feasibility factors are emphasized by the program?

Feasibility is heavily scrutinized, especially patient enrollment. Applicants must demonstrate access to a suitable patient population and provide a realistic plan to meet accrual targets that will produce meaningful outcomes.

What is expected regarding patient recruitment and accrual planning?

The application should spell out how recruitment will be achieved and how accrual targets will be met. The program places particular weight on whether enrollment plans are realistic and whether the applicant can access an appropriate patient population.

Is an inclusion strategy for women and minorities required?

Yes. The application should include an inclusion strategy for women and minorities that fits the study objectives.

Is there an exception to the women and minorities inclusion strategy requirement?

Yes. Studies using human biospecimens or datasets that cannot be linked to an individual or demographic characteristics (often IRB-exempt) are exempt from the women and minority inclusion strategy requirement because demographic tracking is not possible in those cases.

Do applicants need to prove they can access the drug/device/intervention being tested?

Yes. The proposal must document availability and access to the intervention (drug/compound, device, or specialized materials) for the full duration of the trial to reduce the risk of delays or failure due to supply constraints, manufacturing uncertainty, licensing barriers, or missing agreements.

What team capabilities does the DoD expect for ACCCTA projects?

The application should demonstrate that the team is already capable of executing a clinical trial to modern standards, with expertise across clinical trial conduct, statistics, data management, and (when applicable) FDA-related processes.

Is a study coordinator required or expected?

A study coordinator (or coordinators) is expected to manage the clinical protocol through the local IRB of record, handle other federal regulatory approval processes, coordinate multi-site activities when relevant, and actively support participant accrual.

What does the opportunity say about FDA regulatory sponsorship responsibilities?

If the project requires it, the program expects a clear commitment and capability to serve as the FDA regulatory sponsor, including fulfilling sponsor responsibilities described in 21 CFR 312, Subpart D.

What are the expectations for the statistical analysis plan?

Applicants must provide a clear statistical analysis plan, including power and sample size projections that match the study objectives.

What are the expectations for data management and trial databases?

Applicants must provide a data management plan that protects data integrity and uses an appropriate database. If a Regulatory Agency requires it, the trial must use a 21 CFR 11-compliant database and appropriate data standards to support auditability, secure electronic records, and regulatory-grade data quality.

Who is the sponsoring agency and administering office for this opportunity?

This is a Department of the Army opportunity administered through USAMRAA.

What is the Funding Opportunity Number (FON) and CFDA listing?

The Funding Opportunity Number is HT942524PRCRPACCCTA, and the CFDA listing is 12.420.

What is the eligibility for this opportunity?

Eligibility is listed as unrestricted.

What was the closing date provided for this opportunity?

The original closing date provided was October 15, 2024.

How many awards did the agency anticipate making?

The agency anticipated making about five awards.

Is an award ceiling specified in the provided information?

No. The award ceiling is not specified in the provided text.

What types of projects are not a fit for ACCCTA based on the description?

Based on the description, projects that are primarily exploratory lab work, projects that rely on new preclinical or animal studies, or projects where a clinical trial is not ready to start within the stated timeline (12 months, or up to 18 months if regulated) would not match the mechanism's stated intent and requirements.

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