Opportunity Information: Apply for W81XWH 16 PCRP CCRSA
Apply for W81XWH 16 PCRP CCRSA
- 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 Prostate Cancer Clinical Consortium Research 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 22, 2016.
- Applicants must submit their applications by Oct 06, 2016. (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 8 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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Opportunity Summary:
The DoD Prostate Cancer Clinical Consortium Research Site Award (FY16 PCRP; Funding Opportunity Number W81XWH-16-PCRP-CCRSA) is a Department of Defense Prostate Cancer Research Program (PCRP) grant/cooperative agreement intended to expand and strengthen the existing Prostate Cancer Clinical Trials Consortium (PCCTC) by adding new Clinical Research Sites. Rather than funding a specific standalone research project, this mechanism is designed to build the practical infrastructure, partnerships, and readiness a site needs so the Consortium can launch and run prostate cancer clinical trials quickly and consistently across multiple organizations. The overarching emphasis is on enabling Phase II trials or Phase II-linked Phase I trials (Phase I/II) that test high-impact, novel therapeutic agents or treatment approaches, particularly those aligned with the FY16 PCRP overarching challenges.
A central feature of the opportunity is its focus on speed and coordination in clinical testing. Awarded sites are expected to plug into an established national and international network that already includes 11 Clinical Research Sites and a single Coordinating Center. The Coordinating Center acts as the operational hub for the Consortium: it supports trial selection and prioritization, protocol and regulatory coordination, study management and monitoring, data collection and statistical support, and intellectual and material property coordination. In practice, this means the Coordinating Center helps standardize and streamline how trials are chosen, activated, managed, and analyzed so that promising prostate cancer therapies can move through clinical evaluation with fewer delays.
The scientific priorities strongly favor clinical trials that not only test therapeutics, but also incorporate biomarker components when feasible. The PCRP specifically encourages Phase I/II studies that investigate biomarkers relevant to risk assessment, early detection, prediction of aggressiveness, and disease progression. This reflects a broader goal: improving how prostate cancer is characterized and treated by pairing therapeutic interventions with measurable biological signals that can help guide patient selection, predict response, or clarify mechanisms of action. The intended long-term outcome is to accelerate the development of meaningful new interventions that reduce the overall burden and impact of prostate cancer.
Operationally, funded Clinical Research Sites become part of the Consortium’s governance and trial-development process through the Clinical Consortium Committee (CCC), which consists of the Coordinating Center principal investigator and the principal investigators from each Clinical Research Site. The CCC collaboratively develops and maintains procedures for selecting which trials the Consortium will run. A representative from the PCRP must be invited to CCC meetings and other formal Consortium meetings, reflecting the cooperative and coordinated nature of the program and the DoD’s interest in maintaining visibility into planning and execution. While trial ideas can originate within or outside the Consortium, any site may serve as an entry point for externally originated trials, and the Coordinating Center is responsible for facilitating the overall intake and implementation workflow.
A key expectation attached to funding is early participation in active Consortium trials. Sites that are recommended for funding are required to participate in at least one PCCTC clinical trial during the first year of the performance period. This requirement underscores that the award is about immediate operational capability and contribution to ongoing Consortium execution, not a slow ramp-up toward future participation. At the same time, the award’s stated purpose is to fund the collaborations and resources needed to execute trials rapidly, but not to fund the research itself or the development of new clinical protocols. Applicants are therefore encouraged to leverage existing DoD investments whenever possible by implementing trials that already have DoD support.
Eligibility is broadly described as unrestricted (open to any entity type, subject to any additional eligibility language in the full announcement). The opportunity explicitly encourages applications from both US and international institutions to support global investigation and accrual, and it also encourages investigators with access to patients in the Military Health System. In addition, the DoD highlights the importance of reaching patients from disproportionately affected populations, encouraging submissions from institutions with enhanced access to those groups, which can improve representativeness, equity in trial participation, and the generalizability of findings.
From an administrative standpoint, this is a discretionary DoD funding opportunity administered by the Department of Defense, Department of the Army, USAMRAA, under CFDA 12.420, with an original posting date of June 22, 2016 and an original closing date of October 6, 2016. The opportunity anticipated making up to eight awards. The listed award ceiling is shown as 0 in the source data, which typically indicates the ceiling was not specified in that field or was described elsewhere in the full solicitation rather than as a single fixed cap.
FAQs: DoD Prostate Cancer Clinical Consortium Research Site Award (FY16 PCRP; W81XWH-16-PCRP-CCRSA)
What is the DoD Prostate Cancer Clinical Consortium Research Site Award?
This funding opportunity is a Department of Defense Prostate Cancer Research Program (PCRP) award intended to expand and strengthen the Prostate Cancer Clinical Trials Consortium (PCCTC) by adding new Clinical Research Sites. The emphasis is on building the infrastructure, partnerships, and readiness needed for a site to participate in Consortium-led prostate cancer clinical trials.
Is this award meant to fund a specific research project?
No. This mechanism is not designed to fund a standalone research project. Its purpose is to support the practical infrastructure and collaborations a site needs so the Consortium can launch and run trials quickly and consistently across multiple organizations.
What kinds of trials does the Consortium focus on?
The opportunity emphasizes Phase II trials and Phase II-linked Phase I trials (Phase I/II) that test high-impact, novel therapeutic agents or treatment approaches, particularly those aligned with the FY16 PCRP overarching challenges.
Does the opportunity encourage including biomarkers in clinical trials?
Yes. The PCRP strongly encourages clinical trials to incorporate biomarker components when feasible, including Phase I/II studies that investigate biomarkers relevant to risk assessment, early detection, prediction of aggressiveness, and disease progression.
What is the intended long-term outcome of this award?
The stated long-term goal is to accelerate the development of meaningful new interventions that reduce the overall burden and impact of prostate cancer, including improving how prostate cancer is characterized and treated by pairing therapeutics with measurable biological signals.
How large is the existing PCCTC network?
The established network includes 11 Clinical Research Sites and a single Coordinating Center, and this award adds new Clinical Research Sites to that structure.
What does the Coordinating Center do?
The Coordinating Center serves as the operational hub of the Consortium. It supports trial selection and prioritization, protocol and regulatory coordination, study management and monitoring, data collection and statistical support, and intellectual and material property coordination. It helps standardize and streamline how trials are chosen, activated, managed, and analyzed.
How are Consortium decisions made about which trials to run?
Trial selection and related operating procedures are developed and maintained collaboratively through the Clinical Consortium Committee (CCC). The CCC consists of the Coordinating Center principal investigator and the principal investigators from each Clinical Research Site.
Is there DoD involvement in Consortium meetings?
Yes. A representative from the PCRP must be invited to CCC meetings and other formal Consortium meetings, reflecting the cooperative and coordinated nature of the program and the DoD interest in visibility into planning and execution.
Where can trial ideas come from?
Trial concepts can originate from within the Consortium or from outside it. Any site may serve as an entry point for externally originated trials, and the Coordinating Center is responsible for facilitating the overall intake and implementation workflow.
What is the expectation for new sites during the first year?
Sites recommended for funding are required to participate in at least one PCCTC clinical trial during the first year of the performance period. This reflects an expectation of early operational readiness and immediate contribution to ongoing Consortium execution.
Does the award fund the research itself or new protocol development?
The opportunity states that it is intended to fund the collaborations and resources needed to execute trials rapidly, but not to fund the research itself or the development of new clinical protocols.
Are applicants encouraged to leverage existing DoD investments?
Yes. Applicants are encouraged to leverage existing DoD investments whenever possible by implementing trials that already have DoD support.
Who is eligible to apply?
Eligibility is described as unrestricted (open to any entity type), subject to any additional eligibility language in the full announcement.
Are international institutions allowed or encouraged to apply?
Yes. The opportunity explicitly encourages applications from both US and international institutions to support global investigation and accrual.
Is there an emphasis on access to specific patient populations?
Yes. The opportunity encourages investigators with access to patients in the Military Health System. It also highlights the importance of reaching patients from disproportionately affected populations and encourages submissions from institutions with enhanced access to those groups.
What agency administers this funding opportunity?
This is a discretionary Department of Defense funding opportunity administered by the Department of Defense, Department of the Army, USAMRAA, under CFDA 12.420.
What is the Funding Opportunity Number?
The Funding Opportunity Number is W81XWH-16-PCRP-CCRSA.
When was the opportunity originally posted and when did it close?
The original posting date was June 22, 2016, and the original closing date was October 6, 2016.
How many awards were anticipated?
The opportunity anticipated making up to eight awards.
What was the award ceiling?
The source data lists the award ceiling as 0, which typically indicates the ceiling was not specified in that field or was described elsewhere in the full solicitation rather than as a single fixed cap.
What makes this opportunity different from a typical clinical trial grant?
Instead of funding a specific trial as a standalone project, this award focuses on building site-level readiness and integration into an existing Consortium with standardized processes and centralized operational support, with an emphasis on speed and coordination in clinical testing.
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