DoD Kidney Cancer, Clinical Consortium Award | HT9425 23 KCRP CCA

Opportunity Information: Apply for HT9425 23 KCRP CCA

The DoD Kidney Cancer, Clinical Consortium Award (CCA) is a FY23 Kidney Cancer Research Program (KCRP) funding opportunity designed to build and strengthen a multi-institution clinical trial network that can rapidly run kidney cancer phase 2 trials, or phase 1 trials that are directly linked to phase 2 (phase 1/2). The emphasis is on testing high-impact, genuinely novel therapeutic agents or therapeutic approaches that could meaningfully change how kidney cancer is treated, rather than supporting incremental "next-step" variations of existing standards of care. A key point in this mechanism is that the award is intended to pay for the consortium infrastructure and the collaboration engine (the people, systems, processes, and shared resources that make trials move quickly and cleanly), not the direct costs of running the clinical trials themselves.

Structurally, KCRP intends to fund a total of seven awards under this announcement: one Coordinating Center (which also functions as a Clinical Research Site) and six additional Clinical Research Sites. Applicants must specify whether they are applying to be the Coordinating Center (with a site) or a site only. If an institution applies to be the Coordinating Center and is not selected for that role, it can still be considered for funding as a Clinical Research Site. The funded Coordinating Center and Sites will also be expected to integrate with additional Sites that KCRP may add in future years, so the program is set up to be expandable rather than fixed.

The Coordinating Center is the operational hub of the entire consortium. Beyond enrolling patients like any other site, it is responsible for the administrative, regulatory, communications, and data backbone that allows multiple institutions to act like one coordinated trial enterprise. That includes coordinating how trials are proposed and selected, harmonizing protocol development and management, coordinating regulatory requirements across institutions (including local IRB compliance and FDA-related requirements for investigational agents/devices/procedures), overseeing study management and monitoring, providing data collection and data management systems with appropriate access controls and security, building statistical plans for consortium trials, and putting workable processes in place for intellectual and material property issues as well as publication and dissemination of results. The Coordinating Center must also establish quality assurance and quality control mechanisms such as real-time and remote monitoring, adverse event reporting pathways, accrual tracking and reporting, specimen and imaging handling/banking workflows, and ongoing interim outcome evaluation.

A distinctive requirement of this opportunity is that the Coordinating Center must be ready to launch two initial clinical trials within the first 6 months of the performance period, and the funding for those two trials is described as already secured. Every funded participant (the Coordinating Center and all Clinical Research Sites) must participate in at least one of these initial trials, which is meant to force early alignment and demonstrate that the consortium can activate trials quickly rather than spending the first year only on planning.

Governance is handled through a Clinical Consortium Steering Committee made up of the Coordinating Center PI, each Clinical Research Site PI, and consumer advocates. The consumer advocates must be kidney cancer patients or caregivers with strong familiarity with current kidney cancer research issues, and their committee role is expected to be independent of their employment at any participating institution. During the period of performance, the Coordinating Center PI chairs this Steering Committee. The Steering Committee is responsible for developing and maintaining the procedures used to choose which trials the consortium will run, and a KCRP Grants Officer Representative must be invited to Steering Committee meetings and other formal consortium meetings, reinforcing that DoD will have visibility into consortium operations.

Clinical Research Sites are expected to be fully engaged partners, not passive enrollment locations. Each Site must help identify and bring forward new trials, including trials that originate outside the consortium (any site can serve as an entry point for outside trial concepts, with the Coordinating Center facilitating the process). Sites are expected to attend meetings, follow consortium standard operating procedures, accrue patients (including from high-risk, underserved, and/or military populations highlighted in the KCRP strategic focus areas), submit high-quality data on time, and support protocol-specified laboratory projects when needed (for example, tumor biology correlative work). Each Site must also present at least two clinical trials per year for consortium consideration (and the Coordinating Center has this obligation in addition to the two initial trials it must launch early). Sites must designate clinical research coordination staff who can work across institutions to move protocols through regulatory approval and keep accrual and study activities on track.

The award builds in performance-based accountability. After the first year, continuation options for each participant are contingent on meeting performance metrics specified in the assistance agreements. While the Steering Committee will set specific accrual minimums and maximums per trial in the consortium SOPs, the announcement signals clear expectations. For the Coordinating Center, targets include completing at least four trials in the first 12 months, maintaining at least eight open trials at any given time after the first year, and successfully advancing agents from at least 20 consortium trials toward further testing (such as phase 3) with real potential to change clinical practice. For both the Coordinating Center and Sites, there are explicit inclusion goals tied to enrolling at least 5 percent of participants from high-risk, underserved, and/or military populations across consortium trials (with Sites also expected to meet that 5 percent threshold). Clinical Research Sites are also expected to participate in at least eight consortium-initiated trials over four years and to propose at least eight trials over four years (two per year), alongside timely, quality data submission.

Because the program is meant to create lasting capability rather than a temporary project team, Coordinating Center applications must include a financial sustainability plan describing how the consortium will continue after the award period ends. That plan is expected to leverage collaborations, industry sponsorship, and other funding mechanisms. The opportunity also encourages the consortium to leverage other DoD funding avenues (such as DoD clinical trial or translational award mechanisms) to support the clinical research and correlative science that this infrastructure-focused award does not directly pay for.

Eligibility is described as unrestricted (open to any type of entity, subject to any clarifications in the full announcement), and both U.S. and international institutions are encouraged to apply to support global investigation capacity. Institutions with access to high-risk, underserved, and/or military patient populations are particularly encouraged, aligning trial access and generalizability with DoD priorities. Prior recipients of a KCRP Clinical Consortium Award must include a past performance discussion, including how well they met prior metrics and what they contributed to consortium activities; if COVID-19 or another major disruption affected performance, applicants are expected to explain impacts and how they would mitigate similar issues going forward.

From an administrative standpoint, awards will be made as assistance agreements, meaning they may be grants or cooperative agreements depending on how much substantial involvement the DoD anticipates during performance. If substantial involvement is expected (such as collaboration, participation, or intervention during the work), a cooperative agreement would be used; otherwise, a grant may be used. This opportunity was posted by the Department of Defense, Department of the Army (USAMRAA), under Funding Opportunity Number HT9425-23-KCRP-CCA, with an original closing date of November 9, 2023, and an expectation of seven total awards (six Sites plus one Coordinating Center).

• 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 Consortium 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 Jul 13, 2023.
• Applicants must submit their applications by Nov 09, 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 7 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.

Apply for HT9425 23 KCRP CCA

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