DoD Kidney Cancer, Clinical Consortium – Clinical Trial Site Award | W81XWH 20 KCRP CTSA

Opportunity Information: Apply for W81XWH 20 KCRP CTSA

The DoD Kidney Cancer, Clinical Consortium - Clinical Trial Site Award (CTSA) is a Fiscal Year 2020 funding opportunity from the Department of Defense (DoD), managed through the Congressionally Directed Medical Research Programs (CDMRP) Kidney Cancer Research Program (KCRP). Its main purpose is to expand the Kidney Cancer Research Consortium (KCRC) by adding up to two new Clinical Trial Sites. Rather than paying for the scientific experiments or drug development work directly, this mechanism is built to strengthen the infrastructure that allows multiple institutions to run investigator-initiated kidney cancer clinical trials quickly and consistently. In practice, that means building the staffing, coordination processes, and shared operational capacity needed to design and execute Phase I or Phase I-linked Phase I/II (Phase I/II) trials that test promising therapeutic approaches for prevention, detection/diagnosis, disease management, or treatment of kidney cancer.

The opportunity is centered on plugging new institutions into an existing consortium structure that already includes one Coordinating Center and three Clinical Trial Sites. The Coordinating Center functions as both a trial site and the hub that keeps the consortium running day to day. It provides administrative and operational leadership, supports protocol and regulatory coordination, handles study management and monitoring, and leads data collection, data management, and statistical functions. It also helps manage intellectual and material property coordination and promotes best practices for recruiting human subjects, including helping route potential participants to the most appropriate trials across the network. A key expectation is that every participating site, including the Coordinating Center, stays actively engaged by participating in at least two KCRC trials at all times, whether those trials are new or already underway.

Governance for the consortium is organized through a Clinical Consortium Steering Committee made up of the Coordinating Center Principal Investigator (PI), the PI from each Clinical Trial Site, and consumer advocates. The consumer advocates are required to be kidney cancer patients or caregivers with a strong working familiarity with the kidney cancer research landscape, and their committee role is expected to be independent of their employment at any participating institution. The Steering Committee collaboratively develops and maintains the procedures used to select which clinical trials the consortium will run. The KCRP Grants Officer Representative (GOR) must be invited to Steering Committee meetings and other formal consortium meetings, reflecting the hands-on coordination typical of DoD assistance mechanisms.

Applicants pursuing CTSA funding are expected to understand the current clinical trial landscape and the clinical priorities in kidney cancer, and they are encouraged to align their approach with the KCRP Strategic Plan. The consortium also encourages investigators to leverage other DoD funding opportunities when appropriate, for example by seeking separate translational or correlative-study support alongside the consortium clinical trial work. The announcement further points applicants to recommendations from the Congressionally mandated Metastatic Cancer Task Force, encouraging ideas that can help accelerate clinical and translational research for advanced and recurrent cancers, as long as the ideas fit the program limits and FY20 KCRP priorities. As with many DoD medical research programs, the work must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the broader American public.

For the new Clinical Trial Sites being added, the award comes with concrete operational responsibilities and performance expectations. Sites may be required to attend a pre-award planning meeting to align on consortium operations, reporting and evaluation requirements, and award negotiations. Once participating, each site must fully engage in the consortium trial pipeline, including introducing and helping select trials, attending meetings, collecting and submitting data on time, and following consortium operating procedures. Each Clinical Trial Site is expected to bring forward at least two clinical trial concepts per year for consortium consideration. Sites must also meet patient accrual targets: at least 15 patients per year across open and recruiting KCRC trials, either through their own institution or via partnerships with non-consortium institutions. The announcement also emphasizes inclusion by requiring that, within each site accrual totals, at least 5 patients must be from disproportionately affected populations. In addition, there is an expectation that sites contribute meaningfully to studies that originated at other consortium sites (the text specifies at least 20 patients as contributions to trials from other consortium sites, underscoring cross-site collaboration rather than siloed enrollment).

Operationally, each funded Clinical Trial Site must provide a Clinical Trial Coordinator who will work closely with coordinators at other sites and with the supervising coordinator at the Coordinating Center. This role is meant to speed protocols through regulatory approvals, support patient accrual across the network, coordinate study activities, and keep communication flowing across sites. Sites also must implement the consortiums core data collection methods, comply with quality assurance and quality control procedures, and participate in a monitoring program managed by the Coordinating Center. They must follow consortium plans for acquiring, delivering, and storing biological samples and study data, and provide materials needed for verification and review of protocol-related procedures (examples include pathology, imaging approaches, surgical methods, and therapeutic administration details). Compliance expectations extend to FDA requirements for investigational agents when applicable and to local Institutional Review Board (IRB) requirements for human subjects protection. Sites are also expected to adhere to consortium processes for timely publication of major findings and to follow consortium procedures for resolving intellectual and material property issues. Performance is reviewed with input from an External Advisory Board (EAB), and sites must provide annual progress reports and a final comprehensive report, along with any additional reporting required under the assistance agreement.

Funding is provided through assistance agreements, meaning awards can be either grants or cooperative agreements depending on the level of anticipated DoD involvement during performance. If substantial government involvement is expected (for example, collaboration or participation in the work), the mechanism would be structured as a cooperative agreement; if not, it would be structured as a grant. For budgeting, the anticipated direct costs for a Clinical Trial Site award are capped at $300,000 per year for up to two years, with a maximum of $600,000 total per award over the full period of performance. Across the program, CDMRP projected about $1.92 million total over two years to support approximately two awards, with $960,000 allocated for the first year and options for a second year dependent on FY21 appropriations. Continuation into the second year is not automatic; it is contingent on meeting performance metrics after the first year as defined in the award agreement. Those metrics include enrolling at least 15 patients per year, maintaining participation in at least two consortium trials at all times, presenting at least two trial concepts per year, and submitting high-quality data on schedule as directed by the Coordinating Center.

Administratively, the opportunity (Funding Opportunity Number W81XWH-20-KCRP-CTSA; CFDA 12.420) was listed as discretionary funding in the science and technology/research and development category. Eligibility is described as unrestricted (open to any entity type, subject to any additional clarifications in the full announcement). The agency is the Department of Defense, Department of the Army, through USAMRAA. The posting indicates an original application closing date of September 23, 2020, with awards anticipated by no later than September 30, 2021, and with federal funds time-limited by fiscal-year expiration rules (FY20 funds expected to expire September 30, 2026, and the FY21 option funds expected to expire September 30, 2027). Overall, the CTSA is best understood as a capacity-building award that buys speed, consistency, and collaboration across institutions so the consortium can move promising kidney cancer therapeutic trials into Phase I and Phase I/II testing more efficiently and with stronger enrollment and data quality.

• 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 – Clinical Trial Site 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 03, 2020.
• Applicants must submit their applications by Sep 23, 2020. (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 (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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