Opportunity Information: Apply for W81XWH 19 KCRP CCA
The DoD Kidney Cancer Research Program (KCRP) Clinical Consortium Award is designed to build and run a coordinated network of top-tier institutions that can rapidly carry out investigator-initiated kidney cancer clinical trials. The central purpose is not to directly fund the experimental therapy work itself, but to pay for the shared consortium infrastructure that makes multi-site Phase I and Phase I/II linked clinical trials feasible at speed and at high quality. The consortium is expected to advance high-impact, novel therapeutic strategies and clinical interventions that improve outcomes and reduce the overall burden of kidney cancer, with proposed work aligned to the program's clinical priorities and broader strategic plan.
Under this mechanism, DoD intends to fund one Coordinating Center and at least three Clinical Trial Sites total (the Coordinating Center also functions as one of the Clinical Trial Sites), with each entity receiving its own separate award. Applicants must choose their role at the pre-application stage: either applying as the Coordinating Center plus a trial site, or as a Clinical Trial Site only. The consortium is built to support Phase I, Phase I/II, and Phase II-focused activity around prevention, detection/diagnosis, management, and treatment, but with a clear emphasis on therapeutic interventions and an expectation that the network can continuously propose, select, and execute trials as a functioning engine rather than a one-off collaboration.
A major feature is the Coordinating Center's responsibility to serve as the operational hub for the entire consortium. This includes administrative leadership, trial and protocol coordination, regulatory coordination, study management and monitoring, centralized data collection and data management, statistical planning, and coordination of intellectual and material property arrangements across institutions. The Coordinating Center must also stand up the consortium quickly by preparing two interventional clinical trial protocols (with funding already secured) that must open for recruitment within the first six months of the performance period. After those first six months, the Coordinating Center is expected to keep at least two trials open at all times, acting as the information and planning nexus while promoting best practices for human subjects recruitment and helping route patients to the most appropriate trials across sites.
Each Clinical Trial Site has substantial operational and recruitment obligations. Sites are expected to participate fully in trial selection and execution, maintain strong data submission and meeting participation, and provide a dedicated Clinical Trial Coordinator to help move protocols through regulatory approvals, manage accrual, and keep cross-site communication running smoothly. Each site must present at least two clinical trials per year for consortium consideration, participate in at least one of the two initial trials launched early by the Coordinating Center, and comply with consortium-wide standards for data collection, quality assurance, and quality control. Sites must also support monitoring requirements (including real-time and remote monitoring approaches managed by the Coordinating Center), specimen and imaging handling plans, and provide materials needed for verification of protocol-related procedures such as pathology, imaging, surgical methods, and therapeutic administration.
The opportunity places strong emphasis on accrual performance and inclusion. Both the Coordinating Center and each Clinical Trial Site are held to minimum recruitment metrics of 25 patients per year per open, recruiting trial, which can be met independently or via partnerships with non-consortium institutions. Importantly, at least 20 of the 25 accrued patients at each site must be contributions to trials originating from other consortium sites, reinforcing cross-site participation rather than siloed enrollment. In addition, at least 5 accrued patients per site must come from disproportionately affected populations, with the announcement explicitly calling out disparities that can be tied to factors such as socioeconomic status, access to care, age, geography, race, and ethnicity. Applications from organizations with enhanced access to patients in the Military Health System and/or to disproportionately affected populations are especially encouraged, and both U.S. and international institutions are invited to apply to facilitate global investigations.
Governance is structured around a Clinical Consortium Steering Committee composed of the Coordinating Center Principal Investigator, each Clinical Trial Site PI, and consumer advocates. These consumer advocates must be kidney cancer patients or caregivers with a high-level understanding of current kidney cancer research issues, and their committee role should be independent of their employment at any participating institution. The Coordinating Center PI chairs the Steering Committee during the performance period, and the committee collectively develops and maintains the procedures used to select trials for consortium implementation. DoD oversight is built in: the KCRP Grants Officer Representative must be invited to Steering Committee meetings and other formal consortium meetings.
External oversight is provided through an External Advisory Board (EAB) that includes kidney cancer researchers and consumer advocates who are not part of the consortium, along with KCRP Programmatic Panel members. The EAB is assembled by the Steering Committee and provides scientific and administrative guidance to the government. The EAB chair and a USAMRMC representative are invited to regular Steering Committee meetings and must receive agendas and minutes. The Coordinating Center PI and Clinical Trial Site PIs must deliver written and oral briefings to the EAB at least twice per year in semi-annual, one-day meetings, and the government may require quarterly reporting from the Coordinating Center as well. Continued funding after the first year is not automatic; the award uses annual option periods, and the government can decide whether to exercise those options based on performance against the required metrics and other program considerations.
Financially, the direct cost expectations for the full period of performance are capped at $3 million for the Coordinating Center and $600,000 for each Clinical Trial Site, with the overall program projecting about $7.68 million over three years to support approximately one Coordinating Center award and three Clinical Trial Site awards. Funding is planned in annual increments (about $2.56 million per year), with each performance period and option period lasting 12 months. Awards are contingent on federal funding availability, application volume, and scientific/programmatic merit. The mechanism supports assistance agreements, meaning awards may be structured as grants or cooperative agreements depending on the degree of DoD involvement during performance. The announcement also notes that the proposed work must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public, and it encourages applicants to leverage other DoD investment opportunities when needed (for example, pursuing separate translational awards to support correlative studies linked to the clinical trials).
Key identifiers and logistics in the source listing include Funding Opportunity Number W81XWH 19 KCRP CCA, agency oversight through the Department of Defense (Department of the Army, USAMRAA), and an original closing date of October 1, 2019, with awards anticipated no later than September 30, 2020. Overall, the award is best understood as a capacity-building and execution framework: it funds the operational backbone, governance, data systems, regulatory pathways, monitoring, and collaboration structures needed to consistently launch and run early-phase kidney cancer trials across multiple institutions, with measurable enrollment expectations and explicit attention to equitable recruitment and military-relevant impact.Apply for W81XWH 19 KCRP CCA
- 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 Jun 18, 2019.
- Applicants must submit their applications by Oct 01, 2019. (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 3 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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Frequently Asked Questions (FAQs) - DoD Kidney Cancer Research Program (KCRP) Clinical Consortium Award
1. What is the KCRP Clinical Consortium Award intended to do?
This award is designed to build and operate a coordinated network (a clinical trial consortium) of high-performing institutions that can rapidly conduct investigator-initiated kidney cancer clinical trials across multiple sites. The emphasis is on creating and sustaining the shared operational capacity needed to run trials quickly and consistently, rather than forming a one-time collaboration.
2. Does this award directly fund the experimental therapy being tested in the trials?
The central purpose is not to directly fund the experimental therapy work itself. Instead, the award primarily pays for the consortium-wide infrastructure that makes multi-site Phase I and Phase I/II linked clinical trials feasible at speed and with high quality.
3. What kinds of clinical trials and research activities can the consortium support?
The consortium is expected to support Phase I, Phase I/II, and Phase II-focused activities spanning prevention, detection/diagnosis, management, and treatment. However, there is a clear emphasis on therapeutic interventions and on operating as a continuous trial engine that can propose, select, and execute trials over time.
4. How is the consortium structured under this funding mechanism?
DoD intends to fund one Coordinating Center and at least three Clinical Trial Sites in total. The Coordinating Center also serves as one of the Clinical Trial Sites, and each entity receives its own separate award.
5. What roles can an applicant choose from?
Applicants must choose their role at the pre-application stage. They may apply as either:
- The Coordinating Center (which also functions as a Clinical Trial Site), or
- A Clinical Trial Site only.
6. What are the main responsibilities of the Coordinating Center?
The Coordinating Center serves as the operational hub for the consortium, including:
- Administrative leadership for the consortium
- Trial and protocol coordination
- Regulatory coordination
- Study management and monitoring
- Centralized data collection and data management
- Statistical planning
- Coordination of intellectual and material property arrangements across institutions
7. What are the Coordinating Center's early start-up requirements?
The Coordinating Center must stand up the consortium quickly by preparing two interventional clinical trial protocols (with funding already secured) that must open for recruitment within the first six months of the performance period.
8. After the initial six months, what trial activity level is expected?
After the first six months, the Coordinating Center is expected to keep at least two trials open at all times, helping ensure the consortium functions as a sustained trial execution platform rather than a single project.
9. What are the responsibilities of each Clinical Trial Site?
Each Clinical Trial Site is expected to play an active operational role, including:
- Full participation in trial selection and execution
- Strong performance in data submission and meeting participation
- Providing a dedicated Clinical Trial Coordinator
- Supporting regulatory approvals, accrual, and cross-site communication
- Compliance with consortium-wide standards for data collection, quality assurance, and quality control
- Supporting monitoring requirements (including real-time and remote monitoring approaches managed by the Coordinating Center)
- Following specimen and imaging handling plans
- Providing materials needed to verify protocol-related procedures (such as pathology, imaging, surgical methods, and therapeutic administration)
10. Are Clinical Trial Sites required to propose trials to the consortium?
Yes. Each Clinical Trial Site must present at least two clinical trials per year for consortium consideration.
11. Are Clinical Trial Sites required to participate in the initial trials?
Yes. Each site must participate in at least one of the two initial trials launched early by the Coordinating Center.
12. What are the minimum patient recruitment (accrual) requirements?
Both the Coordinating Center and each Clinical Trial Site are held to minimum recruitment metrics of 25 patients per year per open, recruiting trial. This accrual expectation can be met independently or through partnerships with non-consortium institutions.
13. What does the requirement for cross-site accrual mean?
Of the 25 patients accrued per year per open trial at each site, at least 20 must be contributions to trials that originated from other consortium sites. This is intended to drive cross-site participation and avoid each site enrolling only to its own trials.
14. What are the expectations for enrolling disproportionately affected populations?
At least 5 accrued patients per site must come from disproportionately affected populations. The announcement links disparities to factors such as socioeconomic status, access to care, age, geography, race, and ethnicity.
15. Are certain applicant organizations especially encouraged to apply?
Applications are especially encouraged from organizations with enhanced access to patients in the Military Health System and/or to disproportionately affected populations.
16. Are international institutions eligible or invited to apply?
Yes. The announcement notes that both U.S. and international institutions are invited to apply to facilitate global investigations.
17. How is the consortium governed?
Governance includes a Clinical Consortium Steering Committee composed of the Coordinating Center Principal Investigator (PI), each Clinical Trial Site PI, and consumer advocates. The Steering Committee develops and maintains the procedures used to select trials for consortium implementation.
18. Who can serve as a consumer advocate on the Steering Committee?
Consumer advocates must be kidney cancer patients or caregivers with a high-level understanding of current kidney cancer research issues. Their committee role should be independent of their employment at any participating institution.
19. Who chairs the Steering Committee?
The Coordinating Center PI chairs the Steering Committee during the performance period.
20. What is DoD's role in Steering Committee activities?
DoD oversight is built in. The KCRP Grants Officer Representative must be invited to Steering Committee meetings and other formal consortium meetings.
21. What is the External Advisory Board (EAB) and what does it do?
External oversight is provided through an External Advisory Board that includes kidney cancer researchers and consumer advocates who are not part of the consortium, along with KCRP Programmatic Panel members. The EAB is assembled by the Steering Committee and provides scientific and administrative guidance to the government.
22. What are the reporting and meeting expectations with the EAB?
The EAB chair and a USAMRMC representative are invited to regular Steering Committee meetings and must receive agendas and minutes. The Coordinating Center PI and Clinical Trial Site PIs must provide written and oral briefings to the EAB at least twice per year during semi-annual, one-day meetings. The government may also require quarterly reporting from the Coordinating Center.
23. Is funding guaranteed for all years of the program?
No. Continued funding after the first year is not automatic. The award uses annual option periods, and the government decides whether to exercise those options based on performance against required metrics and other program considerations.
24. What are the funding caps for the Coordinating Center and Clinical Trial Sites?
Direct cost expectations for the full period of performance are capped at $3 million for the Coordinating Center and $600,000 for each Clinical Trial Site.
25. What is the projected total program funding and duration?
The overall program projection is about $7.68 million over three years to support approximately one Coordinating Center award and three Clinical Trial Site awards. Funding is planned in annual increments (about $2.56 million per year), with each performance period and option period lasting 12 months.
26. What kind of award instrument is used (grant vs cooperative agreement)?
The mechanism supports assistance agreements, meaning awards may be structured as grants or cooperative agreements depending on the degree of DoD involvement during performance.
27. What relevance requirement applies to the proposed work?
The announcement states that proposed work must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.
28. Can applicants leverage other DoD opportunities to support related work?
Yes. The opportunity encourages applicants to leverage other DoD investment opportunities when needed, such as pursuing separate translational awards to support correlative studies linked to the clinical trials.
29. What is the Funding Opportunity Number and administering organization?
The Funding Opportunity Number is W81XWH 19 KCRP CCA. Agency oversight is through the Department of Defense (Department of the Army, USAMRAA).
30. What were the key dates listed for this opportunity?
The source listing notes an original closing date of October 1, 2019, with awards anticipated no later than September 30, 2020.
31. What is the simplest way to describe what this award funds?
This award funds the operational backbone of a kidney cancer clinical trial consortium: governance, data systems, regulatory coordination, monitoring, collaboration processes, and the capacity to consistently launch and run early-phase multi-site trials with measurable enrollment expectations and explicit attention to equitable recruitment and military-relevant impact.
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