DoD Kidney Cancer, Clinical Trial Award | HT942524KCRPCTA

Opportunity Information: Apply for HT942524KCRPCTA

The DoD Kidney Cancer Research Program (KCRP) Clinical Trial Award is a Department of Defense funding opportunity aimed at moving kidney cancer clinical trials into action quickly, with an emphasis on studies that could meaningfully change how kidney cancer is treated or managed. It supports interventional clinical trials that test promising products and approaches, including drugs and biologics, medical devices, clinical guidance, and emerging technologies. The mechanism is intentionally broad on trial stage, allowing everything from early, smaller proof-of-concept efforts (such as pilot studies, first-in-human work, or phase 0 trials) that establish feasibility or help design later trials, through larger studies intended to determine efficacy in relevant patient populations.

A defining feature of this award is its focus on readiness and speed to launch. Applicants are expected to start the proposed clinical trial no later than 12 months after the award date. If the study is regulated by a regulatory agency (for example, the FDA or an applicable international regulator), the program allows up to 18 months after the award date to begin. The opportunity also makes clear that this is not seed funding for an idea that still needs basic justification: preliminary data directly relevant to the proposed clinical trial are required and must be included in the application.

The program places strong expectations on feasibility of enrollment and execution. Applications need to show that the investigators can realistically access an appropriate kidney cancer patient population and reach accrual targets in a way that produces meaningful results. This includes a concrete plan for achieving enrollment goals and an inclusion strategy for women and minorities that fits the trial objectives. An exception is noted for studies using de-identified biospecimens or datasets that cannot be linked back to individuals or demographic characteristics (often IRB-exempt); those projects are exempt from the women/minorities inclusion discussion requirement. Beyond participants, applicants must also document that the intervention itself is available for the entire study period, meaning there must be clear access to the drug/compound, device, or other required materials.

Operational capability is a major review focus. The application is expected to demonstrate that the team has the experience and infrastructure to run a clinical trial end-to-end, including appropriate statistical expertise, data management capability, and familiarity with FDA processes when relevant. The solicitation specifically calls for a study coordinator (or coordinators) to shepherd the protocol through the local IRB of record and other applicable regulatory approvals, manage coordination across any multi-site effort, and support participant accrual. Institutional commitment matters as well, and where applicable the institution should be prepared to act as the FDA regulatory sponsor and carry out sponsor responsibilities under 21 CFR 312 (including the requirements described in Subpart D).

Because the award is meant to generate interpretable, decision-ready results, the application must include a clear statistical analysis plan and a power analysis that justifies the projected sample size in relation to the study objectives. A data management plan is also required, including use of an appropriate database that protects data integrity. If a regulatory agency requires it, the trial must use a database compliant with 21 CFR Part 11 and use appropriate data standards. In other words, the program expects applicants to have already thought through how data will be captured, secured, audited (as needed), and analyzed in a way that holds up to clinical and regulatory scrutiny.

The announcement also highlights several broader priorities that applicants are encouraged to align with when relevant. These include nuclear medicine and related techniques that could improve early diagnosis, precision imaging, and targeted therapies, particularly in ways that matter to active-duty Service Members and their families. It also encourages attention to womens health, including considering sex as a biological variable and explaining how findings could improve outcomes for women or advance understanding of sex-based differences. In addition, because CDMRP participates in the congressionally mandated Metastatic Cancer Task Force, applicants are encouraged to consider ideas that address the Task Force recommendations, as long as they fit the kidney cancer program priorities and the scope of this funding mechanism. Across the board, CDMRP emphasizes rigorous study design and reporting practices, drawing on widely accepted principles such as randomization, blinding where feasible, sample-size estimation, and transparent data handling to strengthen reproducibility and translation.

The program strongly encourages military-relevant collaboration. Applications involving investigators in the military services, and partnerships spanning academia, industry, the military, the Department of Veterans Affairs, and other federal agencies are viewed favorably because they can bring unique infrastructure, expertise, and access to distinctive clinical populations. If a project depends on access to specialized resources or databases, the applicant must describe that access at submission and explain how it will be maintained throughout the project.

Only true clinical trials are eligible under this mechanism, and the solicitation uses the regulatory definition in 45 CFR 46.102: research in which one or more human subjects are prospectively assigned to one or more interventions (including placebo or control) to evaluate effects on biomedical or behavioral health-related outcomes. Studies that do not measure safety, effectiveness, and/or efficacy outcomes of an intervention are not considered clinical trials for this opportunity and should instead be directed to other KCRP announcements. The solicitation also points applicants to a CDMRP Human Subjects Resource Document for guidance on compliance expectations.

Regulatory readiness is explicitly built into the timeline and submission requirements. If the trial uses a drug that is not already approved for the proposed use in the country where the research will occur, an Investigational New Drug (IND) application (or equivalent) may be required under 21 CFR 312. The applicant is responsible for providing evidence if an IND is not required, and if an IND is required, it must be submitted to the relevant regulatory agency by the Clinical Trial Award application submission deadline, and it must match the product and indication being tested. Similarly, if the investigational product is a device, an Investigational Device Exemption (IDE) (or equivalent) may be required under 21 CFR 812, with the same expectation: evidence if not required, and submission by the application deadline if required, specific to the device and indication.

From a funding and administrative standpoint, awards will be issued as grants (31 USC 6304). The anticipated budget limit is up to $2,000,000 in direct costs over the full period of performance (with additional restrictions referenced in the full announcement). The Department of Defense expects to allocate about $6.4 million total to make roughly two awards under this mechanism, with final funding dependent on federal appropriations, application volume, and peer and programmatic review outcomes. The opportunity is managed by the Department of the Army (USAMRAA) under CFDA 12.420, eligibility is listed as unrestricted, and the application closing date is October 15, 2024. Awards supported with FY24 funds are expected to be made no later than September 30, 2025, and the FY24 funds associated with resulting awards are expected to remain available for use until September 30, 2030.

• 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 Kidney Cancer, Clinical Trial 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 2024-07-11.
• 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 2 candidate(s).
• Eligible applicants include: Unrestricted.

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