DoD Peer Reviewed Cancer, Advancing Cancer Care through Clinical Trials Award | HT9425 23 PRCRP ACCCT

Opportunity Information: Apply for HT9425 23 PRCRP ACCCT

The DoD Peer Reviewed Cancer Research Program (PRCRP) Advancing Cancer Care through Clinical Trials (ACCCT) Award (Funding Opportunity Number: HT9425 23 PRCRP ACCCT) is a Department of Defense grant/cooperative agreement mechanism meant to push cancer interventions into, and through, human clinical testing. The core purpose is to fund clinical trials that either move a promising approach to the next stage of clinical study or meaningfully improve the standard of care for people living with cancer, as long as the work aligns with at least one FY23 PRCRP Topic Area. In practical terms, this opportunity is designed for teams that already have strong preclinical support and are ready to translate that work into a real-world clinical setting, rather than continuing laboratory or animal studies.

A defining feature of the ACCCT Award is that the funded project must be a clinical trial as the program defines it: a research study where one or more human subjects are prospectively assigned to one or more interventions (including placebo or another control, if relevant) to evaluate effects on biomedical or behavioral health-related outcomes. This means the award is not appropriate for observational studies, basic science, or projects that do not measure safety, effectiveness, and/or efficacy outcomes tied to an intervention. The announcement also makes it clear that investigators who want to do preclinical research should look at other PRCRP announcements instead, because this mechanism is explicitly built around running a trial in humans.

In terms of what can be tested, the ACCCT Award is fairly broad as long as the work is trial-ready. Proposed trials can evaluate new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and emerging technologies or approaches that could change how cancer is treated or supported. The program allows a wide range of trial scales and phases, from early proof-of-concept efforts (such as pilot studies, first-in-human trials, or phase 0 work that establishes feasibility or informs later trial design) all the way to larger trials intended to determine efficacy in a relevant patient population. Regardless of size, the funding has to support the clinical trial itself, not side preclinical experiments.

The program places strong emphasis on translation and measurable impact. Applicants are expected to show that the intervention has significant potential to advance to the next stage of clinical study, transition results into fielded practice (sometimes described as moving into real-world care delivery), or improve the standard of care in an FY23 PRCRP Topic Area. The proposed work must also address one FY23 PRCRP Military Health Focus Area and one FY23 PRCRP Overarching Challenge, signaling that the DoD wants these trials to connect directly to military-relevant health priorities and the program-wide problems it is trying to solve. Importantly, the impact discussion is expected to include quality of life and supportive care considerations during the trial, not only traditional clinical endpoints.

Readiness requirements are strict. Supportive preclinical data relevant to the planned trial are required, and the application needs to present the kind of evidence that justifies initiating a clinical trial now. At the same time, the mechanism explicitly does not allow proposed preclinical research to support an IND or IDE application, and it prohibits animal work. In other words, the program is not paying for the remaining preclinical steps; it is paying for clinical testing based on preclinical work that is already completed and convincing enough to proceed.

Operational feasibility is another major theme. The trial is expected to begin within 12 months of the award date, and by that point the study should have recruited at least two participants. Applicants also need a clear plan for reaching accrual goals, with evidence that they have access to an appropriate patient population large and suitable enough to support meaningful outcomes. The application must address inclusion of women and minority populations in a way that fits the study objectives, and reviewers will assess those inclusion plans. (An exception is noted for certain studies using biospecimens or datasets that cannot be linked to identifiable individuals or demographic characteristics, which are often considered exempt from IRB review.)

The DoD also expects applicants to demonstrate practical access to whatever is being tested. If the trial involves a drug, biologic, device, or specialized materials, the application must document availability and access for the duration of the study. This reduces the risk that a trial stalls because the intervention cannot be manufactured, sourced, or delivered consistently across the planned timeline.

Team capability and compliance infrastructure are treated as essential, not optional. The application should show that the investigative team has hands-on clinical trial experience across key areas like trial operations, statistics, data management, and, when applicable, regulatory pathways involving the FDA or an appropriate international regulatory agency (the term "regulatory agency" is defined that way in the announcement). The program also expects at least one study coordinator who can shepherd the protocol through the local IRB and any other approvals, coordinate multi-site activities if more than one site is involved, and manage participant accrual. Additionally, there must be strong institutional support, and if the project requires an FDA sponsor, the applicant organization needs to show willingness and capacity to serve as the regulatory sponsor and fulfill sponsor responsibilities under 21 CFR 312 Subpart D.

Applications must include robust statistical and data management planning. The program calls for a clearly articulated statistical analysis plan, including a power analysis and sample size justification that matches the study objectives. A data management plan is also required, including an appropriate database to protect data integrity and security. If a regulatory agency requires it, the trial must use a 21 CFR Part 11-compliant database and appropriate data standards, reflecting the expectation that data will be audit-ready and suitable for regulatory and high-confidence clinical interpretation.

Finally, milestone-driven execution is built into the award. Applicants must provide a clear milestone plan, including a path to IRB approval and recruitment of at least two participants by the end of the first year from the award start date. This milestone structure reinforces that the ACCCT Award is intended for trial-ready projects that can launch quickly and produce actionable clinical results, rather than exploratory efforts that may take years to reach patient enrollment.

Administrative details from the notice include that the sponsoring agency is the Department of Defense, Department of the Army (USAMRAA), the assistance listing number is 12.420, eligibility is listed as unrestricted (open to entity types, subject to any specific clarifications in the full announcement), and the funding instrument type is listed as grant and cooperative agreement. The original posting dates show creation on April 4, 2023, with an original closing date of September 27, 2023, and the opportunity anticipated approximately six awards (with the award ceiling not specified as a fixed number in the provided source text).

• 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 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 Apr 04, 2023.
• Applicants must submit their applications by Sep 27, 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 6 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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