Opportunity Information: Apply for W81XWH 13 PCRP CCA
Apply for W81XWH 13 PCRP CCA
- The 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 Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
- This funding opportunity was created on Oct 1, 2013 and posted on Jul 1, 2013.
- Applicants must submit their applications by Oct 9, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $5,100,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 11 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 Award (CCA) is a FY13 Prostate Cancer Research Program (PCRP) funding opportunity run through the U.S. Army medical research enterprise (USAMRAA/USAMRMC) to build and operate a coordinated network that can rapidly launch and run prostate cancer clinical trials. The central purpose is not to pay for the experimental therapy work itself, but to fund the consortium infrastructure that makes multi-site Phase II and Phase I/II (linked Phase I and Phase II) trials move quickly and consistently across institutions. The trials supported through this consortium are expected to focus on high-impact, novel therapeutic agents or treatment approaches aligned with the program's overarching challenges, and proposals are especially encouraged to incorporate biomarkers tied to risk assessment, early detection, predicting aggressiveness, or tracking progression.
The consortium model is structured around roughly 10 Clinical Research Sites plus a single Coordinating Center, with a new FY13 feature requiring at least two additional Affiliate Clinical Research Sites that are selected and supported by the Coordinating Center. Applicants must choose whether they are applying to serve as the Coordinating Center (which also functions as a Clinical Research Site) or as a Clinical Research Site only. If an applicant applies as the Coordinating Center and is not selected in that role, they may still be considered for funding as a Clinical Research Site. The overall intent is to combine leading investigators and capable trial sites into a standing network that can repeatedly identify promising interventions, stand up protocols, accrue patients, and generate results that can advance therapies toward broader clinical use, with the long-term goal of materially reducing the burden of prostate cancer.
The Coordinating Center acts as the operational hub and is responsible for the administrative and technical backbone required for multi-site trials. This includes managing trial selection and protocol coordination, regulatory coordination across sites, study management and monitoring, data collection and data management (including statistics), and coordination of intellectual and material property. A major readiness requirement is that the Coordinating Center must bring at least two initial Phase II or Phase I/II trial protocols that already have secured funding, and the consortium must be ready to initiate these within the first three months of the award period. Every participating site, including the Coordinating Center, is required to participate in at least one of those initial trials, which signals that the program is meant to be immediately operational rather than purely developmental.
Governance is handled through a Clinical Consortium Committee (CCC) made up of the Coordinating Center PI and the Clinical Research Site PIs. This committee collaboratively develops and maintains the procedures for reviewing, selecting, and implementing trials across the network. The program also requires that a PCRP representative be invited to CCC meetings and other formal consortium meetings, ensuring ongoing program visibility and alignment. The consortium is expected to continuously source new trials, including trials that originate outside the consortium, and it is strongly encouraged to leverage prior DoD investments by implementing DoD-funded trials whenever feasible.
Operationally, the Coordinating Center must build and maintain the consortium organizational structure; recruit, integrate, and manage at least two affiliate sites with defined performance metrics; and be able to change affiliate sites (with Government approval) if performance needs warrant it. It must establish cross-site systems for human subjects protection and IRB compliance, and ensure compliance with FDA requirements related to investigational agents, devices, and procedures. It also must maintain a communications plan and ongoing communication systems among sites, implement quality assurance and quality control (including an on-site monitoring program), and manage biospecimen and imaging handling, distribution, analysis, and banking needed for trial execution and analysis. Additional responsibilities include participant registration and accrual tracking, timely medical review of participant data, rapid adverse event reporting, interim outcome evaluation, comprehensive data systems that address access/security/integrity, trial-specific statistical plans, and coordination of intellectual/material property and publication/dissemination procedures. A distinctive sustainability expectation is that the Coordinating Center must develop and execute a plan to make the consortium financially independent from DoD funding by the end of the award period. The consortium is also subject to ongoing review by an External Advisory Board (EAB), with reviews at least twice per year and with Government participation.
Clinical Research Sites are expected to be active, high-performing members of the network rather than passive enrollment centers. They may be required to attend a pre-award planning meeting (at the Government's discretion) and must participate fully in trial introduction and selection, patient accrual (including accrual of disproportionately affected populations), data submission, meeting attendance, and adherence to consortium operating procedures. Each site is expected to present clinical trial concepts for consortium consideration each year, with expectations about the minimum number of trials to be proposed set prior to award, and each application should describe the site's ability to propose new trials and secure funding for them. Sites must meet minimum accrual requirements (also set prior to award) and should describe realistic accrual capabilities. They must designate a Clinical Research Coordinator to work closely with the Coordinating Center and other sites to speed regulatory approvals and coordinate accrual and study activities. Sites must implement core data collection methods, comply with monitoring and specimen/data management plans, submit needed materials for verification and review of protocol-related procedures (for example pathology or imaging), comply with FDA and IRB processes as coordinated by the Coordinating Center, support protocol-specified laboratory work when applicable, participate in publication and IP/material resolution processes, engage in EAB review, and submit annual and final comprehensive reports.
From an eligibility and administrative standpoint, the opportunity is a discretionary cooperative agreement (reflecting substantial programmatic involvement and coordination expectations), open broadly to applicants (unrestricted eligibility, subject to any clarifications in the full announcement). The FY13 posting shows an expected 11 awards and an estimated total funding amount of $5.1 million, with no cost sharing or matching requirement. The funding opportunity number is W81XWH-13-PCRP-CCA, associated with CFDA 12.420 (Military Medical Research and Development). The original and current closing date listed is October 9, 2013, with posting on July 1, 2013, and archive on November 8, 2013.
In practical terms, this award is best understood as funding the machinery of a clinical trials network: shared coordination, regulatory and data infrastructure, monitoring and quality systems, specimen/imaging logistics, and governance mechanisms that allow multiple institutions to act as a single, efficient clinical research enterprise. The scientific payoff is expected to come from the consortium's ability to quickly execute well-chosen Phase II and Phase I/II prostate cancer trials, particularly those that integrate biomarker work and that can reach patients in populations disproportionately affected by prostate cancer, including through U.S. and international collaboration.
FAQs: DoD Prostate Cancer Clinical Consortium Award (CCA) - FY13 PCRP
What is the DoD Prostate Cancer Clinical Consortium Award (CCA)?
The CCA is a FY13 Prostate Cancer Research Program (PCRP) funding opportunity run through the U.S. Army medical research enterprise (USAMRAA/USAMRMC) to build and operate a coordinated network that can rapidly launch and run prostate cancer clinical trials.
What is the main purpose of this award?
The primary purpose is to fund the consortium infrastructure that enables multi-site Phase II and Phase I/II (linked Phase I and Phase II) prostate cancer trials to be initiated and conducted quickly and consistently across institutions. It is not primarily intended to pay for the experimental therapy work itself.
What kinds of clinical trials is the consortium expected to run?
Trials supported through the consortium are expected to focus on high-impact, novel therapeutic agents or treatment approaches aligned with the program's overarching challenges, with an emphasis on Phase II and Phase I/II trials.
Are biomarkers encouraged in trial proposals?
Yes. Proposals are especially encouraged to incorporate biomarkers tied to risk assessment, early detection, predicting aggressiveness, or tracking progression.
How is the consortium structured?
The model is structured around approximately 10 Clinical Research Sites plus a single Coordinating Center. A FY13 requirement adds at least two additional Affiliate Clinical Research Sites that are selected and supported by the Coordinating Center.
What are Affiliate Clinical Research Sites, and who selects them?
Affiliate Clinical Research Sites are additional sites (at least two) that must be selected and supported by the Coordinating Center as part of the FY13 consortium structure.
What are the two application roles available under this opportunity?
Applicants must choose whether they are applying to serve as the Coordinating Center (which also functions as a Clinical Research Site) or as a Clinical Research Site only.
If an applicant applies as the Coordinating Center but is not selected, can they still participate?
Yes. If an applicant applies as the Coordinating Center and is not selected in that role, they may still be considered for funding as a Clinical Research Site.
What does the Coordinating Center do?
The Coordinating Center serves as the operational hub and provides the administrative and technical backbone for multi-site trials. Responsibilities include trial selection and protocol coordination, regulatory coordination across sites, study management and monitoring, data collection and data management (including statistics), and coordination of intellectual and material property.
Is there a readiness requirement to start trials quickly?
Yes. The Coordinating Center must bring at least two initial Phase II or Phase I/II trial protocols that already have secured funding, and the consortium must be ready to initiate these within the first three months of the award period.
Do all participating sites have to join the initial trials?
Yes. Every participating site, including the Coordinating Center, is required to participate in at least one of the initial trials.
How are decisions made about trial selection and consortium procedures?
Governance is handled through a Clinical Consortium Committee (CCC) composed of the Coordinating Center PI and the Clinical Research Site PIs. The CCC collaboratively develops and maintains procedures for reviewing, selecting, and implementing trials across the network.
Is the PCRP involved in consortium meetings?
Yes. The program requires that a PCRP representative be invited to CCC meetings and other formal consortium meetings to support program visibility and alignment.
Does the consortium only run trials developed within the network?
No. The consortium is expected to continuously source new trials, including trials that originate outside the consortium.
Is there an expectation to leverage prior DoD-funded work?
Yes. The consortium is strongly encouraged to leverage prior DoD investments by implementing DoD-funded trials whenever feasible.
What additional operational responsibilities does the Coordinating Center have?
The Coordinating Center must build and maintain the consortium organizational structure; recruit, integrate, and manage at least two affiliate sites with defined performance metrics; and (with Government approval) change affiliate sites if performance needs warrant it. It must also establish cross-site systems for human subjects protection and IRB compliance; ensure compliance with FDA requirements for investigational agents, devices, and procedures; maintain communication systems; implement quality assurance and quality control including on-site monitoring; and manage biospecimen and imaging handling, distribution, analysis, and banking needed for trial execution and analysis.
What data and safety reporting functions are expected?
The Coordinating Center is responsible for participant registration and accrual tracking, timely medical review of participant data, rapid adverse event reporting, interim outcome evaluation, comprehensive data systems addressing access/security/integrity, and trial-specific statistical plans.
Does the Coordinating Center have responsibilities related to intellectual property (IP) and publications?
Yes. The Coordinating Center coordinates intellectual and material property issues and oversees publication and dissemination procedures across the consortium.
Is there a requirement for the consortium to become sustainable without DoD funding?
Yes. A distinctive expectation is that the Coordinating Center must develop and execute a plan to make the consortium financially independent from DoD funding by the end of the award period.
Is there external oversight of consortium performance?
Yes. The consortium is subject to ongoing review by an External Advisory Board (EAB), with reviews at least twice per year and with Government participation.
What is expected of Clinical Research Sites beyond enrolling patients?
Clinical Research Sites are expected to be active, high-performing members of the network. They participate in trial introduction and selection, patient accrual (including disproportionately affected populations), data submission, meeting attendance, adherence to consortium operating procedures, and engagement in EAB review.
Are Clinical Research Sites expected to propose new trial concepts?
Yes. Each site is expected to present clinical trial concepts for consortium consideration each year, with expectations about the minimum number of trials to be proposed set prior to award. Applications should describe the site's ability to propose new trials and secure funding for them.
Are there minimum patient accrual expectations for Clinical Research Sites?
Yes. Sites must meet minimum accrual requirements that are set prior to award, and they should describe realistic accrual capabilities in their application.
Do Clinical Research Sites need a dedicated coordinator?
Yes. Sites must designate a Clinical Research Coordinator to work closely with the Coordinating Center and other sites to expedite regulatory approvals and coordinate accrual and study activities.
What compliance responsibilities do Clinical Research Sites have?
Sites must implement core data collection methods; comply with monitoring and specimen/data management plans; submit materials needed for verification and review of protocol-related procedures (for example, pathology or imaging); comply with FDA and IRB processes as coordinated by the Coordinating Center; and support protocol-specified laboratory work when applicable.
What reporting is required from Clinical Research Sites?
Clinical Research Sites must submit annual and final comprehensive reports.
What type of funding mechanism is this award?
This opportunity is a discretionary cooperative agreement, reflecting substantial programmatic involvement and coordination expectations.
Is eligibility restricted to certain applicant types?
The opportunity is described as open broadly to applicants (unrestricted eligibility), subject to any clarifications in the full announcement.
How many awards and how much total funding were expected for FY13?
The FY13 posting shows an expected 11 awards and an estimated total funding amount of $5.1 million.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
What is the funding opportunity number and CFDA listing?
The funding opportunity number is W81XWH-13-PCRP-CCA, associated with CFDA 12.420 (Military Medical Research and Development).
What were the key dates for this FY13 opportunity?
The posting date was July 1, 2013. The listed original and current closing date was October 9, 2013. The opportunity was archived on November 8, 2013.
In plain terms, what does this award fund?
It funds the "machinery" of a clinical trials network: coordination, regulatory and data infrastructure, monitoring and quality systems, specimen and imaging logistics, and governance mechanisms that allow multiple institutions to function as a single clinical research enterprise.
What is the long-term goal of the consortium?
The long-term goal is to materially reduce the burden of prostate cancer by repeatedly identifying promising interventions, standing up protocols, accruing patients, and generating results that can advance therapies toward broader clinical use.
Does the consortium prioritize enrolling disproportionately affected populations?
Yes. Clinical Research Sites are expected to support patient accrual, including accrual of disproportionately affected populations.
Does the opportunity contemplate collaboration beyond the United States?
Yes. The described scientific payoff includes reaching patients in disproportionately affected populations, including through U.S. and international collaboration.
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