DoD Kidney Cancer, Clinical Trial Award | HT9425 23 KCRP CTA

Opportunity Information: Apply for HT9425 23 KCRP CTA

The DoD Kidney Cancer, Clinical Trial Award (KCRP CTA; Funding Opportunity Number HT9425-23-KCRP-CTA) is a Department of Defense Congressionally Directed Medical Research Programs funding mechanism meant to move early-stage kidney cancer clinical testing forward quickly. It specifically supports rapid implementation of phase 0, phase 1, and phase 1/2 clinical trials that could meaningfully change how kidney cancer is treated or managed. The program is looking for trials that test promising new products or approaches, including drugs and biologics, medical devices, clinical guidance strategies, and emerging technologies. It also welcomes repurposing or reusing existing interventions for new kidney cancer indications, as long as the work is structured as an interventional clinical trial and produces results that justify later, larger efficacy-focused studies that could ultimately shift standard patient care.

A key point is that the award must fund an actual clinical trial as defined by federal standards: human subjects must be prospectively assigned to one or more interventions (including possible placebo or control) to evaluate effects on biomedical or behavioral health outcomes. Projects that do not measure safety, effectiveness, and/or efficacy outcomes for an intervention are not considered clinical trials for this opportunity, and purely preclinical projects are expected to go to other KCRP mechanisms instead. The notice also clarifies that when it references a “Regulatory Agency,” it generally means the U.S. FDA or an equivalent international regulator, depending on where the study is being run and what is being tested.

The opportunity is structured around “readiness” and expects applicants to be positioned to launch quickly. The proposed trial is expected to start within 12 months of the award date, or within 18 months if the study is regulated by a Regulatory Agency (for example, FDA-regulated IND or IDE work). Preliminary data are required and must be directly relevant to the proposed trial, which signals that this mechanism is intended for teams that have already done enough groundwork to justify moving into human testing. Applications also need to demonstrate access to an appropriate patient population and include a realistic accrual plan, along with an intentional strategy to include women and minorities in a way that fits the trial’s objectives. Just as importantly, the applicant must show documented availability of the intervention itself, meaning the drug/compound, device, or other necessary materials must be accessible for the full proposed study period.

Because this is a clinical-trial-centered award, the review expectations extend beyond scientific rationale into operational capability. Applicants are expected to present a team with real clinical trial experience, including expertise in statistics, data management, and (when applicable) FDA processes. The program emphasizes the need for strong coordination capacity, including study coordinator support to shepherd the protocol through the local IRB and any additional federal approvals, manage multi-site activities when relevant, and drive participant recruitment. Where applicable, the institution is expected to show it can serve as the FDA regulatory sponsor and fulfill sponsor responsibilities laid out in 21 CFR 312 (for IND-regulated drug trials), which is often a major operational and compliance commitment.

Statistical and data infrastructure requirements are also spelled out. Applications should include a clear statistical analysis plan, a power analysis that justifies sample size in relation to the study objectives, and a data management plan that uses an appropriate database to protect data integrity. If a Regulatory Agency requires it, the trial must use a 21 CFR Part 11-compliant database and appropriate data standards, reflecting expectations consistent with regulated clinical research.

On the regulatory side, the announcement highlights submission timing expectations that can affect whether an application is even viable. If the trial involves a drug not FDA-approved for the proposed investigational use, an IND may be required; if so, the IND must be submitted to FDA by the application submission deadline, and it must match the specific product and indication proposed (not a loosely related derivative). If an IND is not required, the applicant must provide evidence from the IRB of record or FDA supporting that determination. Similar rules apply to devices: if an IDE is required under 21 CFR 812, the IDE must also be submitted by the application deadline; if not required (or if an abbreviated IDE applies), the applicant must provide documentation supporting that status. For trials run at international sites, the applicant must show that submissions to the relevant national regulatory authorities in the host country or countries have been made by the application deadline.

The award also carries significant public transparency and human-subjects compliance requirements. Funded trials must register on ClinicalTrials.gov before the study begins, and they must post a copy of the informed consent form used to enroll participants on a publicly available federal website in line with federal requirements (referenced as 32 CFR 219). In addition to local IRB or Ethics Committee approval, all DoD-funded work involving human subjects, human data, anatomical substances, or cadavers must go through an additional DoD administrative review and approval pathway via the USAMRDC Office of Human and Animal Research Oversight, specifically the Office of Human Research Oversight (OHRO), before the research can start. Local IRB approval is not required at the moment of application submission, but it is required before OHRO review can occur. The announcement advises planning for up to about three months to complete the OHRO review after all required documents are submitted.

For multi-institutional research, the opportunity reflects current U.S. single-IRB policy (45 CFR 46.114(b)) for non-exempt cooperative research, meaning domestic multi-site studies generally must rely on one IRB. Applicants need to include a written plan for how single-IRB review will be arranged and identify the lead institution responsible for the master protocol and master consent form, as well as serving as the central point of contact for regulatory submissions. The application is also expected to address practical governance issues such as communication and data transfer across sites, handling of specimens and imaging outputs, and an intellectual and material property plan agreed to by all participating institutions, which is a common friction point in multi-site trials and is therefore explicitly called out.

Strategically, the program encourages applicants to collaborate with “Qualified Collaborators,” especially established, federally funded partnerships or consortia (an example provided is the Kidney Cancer Research Consortium). The intent is to reuse and leverage existing infrastructure like clinical trial databases, statistical cores, tissue repositories, and shared operations to reduce duplication and improve efficiency. If this type of collaboration is proposed, a letter of collaboration is required and must clearly describe what services or infrastructure the collaborator will provide and how that support benefits the government’s investment. The notice also encourages alignment with recommendations from the Congressionally mandated Metastatic Cancer Task Force, as long as the proposed work fits within the opportunity’s scope and the FY23 KCRP priorities. Separately, collaborations between military or Veteran institutions and non-military institutions are strongly encouraged to leverage unique populations, expertise, and infrastructure relevant to service members, military families, and the public.

From a funding and award-structure standpoint, this opportunity is offered as an assistance agreement, meaning awards will be issued as either a grant or a cooperative agreement depending on how much involvement the DoD anticipates having during the project. If the government expects no substantial involvement, it will generally be a grant; if substantial involvement is expected (for example, active collaboration or participation), it will generally be a cooperative agreement, and the specific nature of that involvement will be laid out in the award. The anticipated direct cost limit for the full period of performance is not to exceed $1.5 million. Programmatically, CDMRP projected approximately $2.4 million total to fund about one award, contingent on appropriations, application volume, and merit. Awards were expected to be made no later than September 30, 2024, and the underlying FY23 funds were anticipated to remain available for obligation and use within federal limits through September 30, 2029.

Eligibility is listed as unrestricted (open to any type of entity, subject to any additional clarifications in the full announcement). The administering agency is the Department of Defense, Department of the Army, through USAMRAA, and the opportunity is cataloged under CFDA 12.420. The original posting date was June 5, 2023, with an original closing date of October 6, 2023. Finally, applicants proposing to use DoD or VA resources or access active-duty or VA patient populations must describe that access in the application and include a plan to maintain it throughout the study, since feasibility and continuity of access can make or break a clinical trial’s ability to meet accrual and timeline commitments.

• 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 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 Jun 05, 2023.
• Applicants must submit their applications by Oct 06, 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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