Opportunity Information: Apply for W81XWH 11 PCRP CTA
Apply for W81XWH 11 PCRP CTA
- 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 FY11 Prostate Cancer Research Program Clinical Trial 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 May 5, 2011 and posted on May 5, 2011.
- Applicants must submit their applications by Sep 1, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,800,000.00 to eligible and selected applicants.
- 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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Opportunity Summary:
The DoD FY11 Prostate Cancer Research Program (PCRP) Clinical Trial Award is a funding opportunity from the U.S. Army (USAMRAA) designed specifically to support the rapid launch and execution of prostate cancer clinical trials that test novel interventions with real potential to meaningfully change how prostate cancer is treated or managed. This mechanism has been in place since FY01, with a relatively selective funding history (97 applications received and 18 recommended for funding at the time of the announcement), which signals that proposals are expected to be mature, well-justified, and ready to move quickly into patient enrollment rather than remaining at an exploratory preclinical stage.
A key feature of this award is that the budget must be used to run a clinical trial and cannot support preclinical research. The program defines a clinical trial as a prospective study that accrues human participants and tests an intervention (such as a drug, device, biologic, surgery, rehabilitation approach, behavioral strategy, or similar) with measurable outcomes related to exploratory findings, safety, effectiveness, and/or efficacy. Eligible trial types include Phase 0/I, Phase I, Phase I/II, or Phase II drug trials, and Class II or Class III device trials. If an applicant proposes an exploratory Phase 0 effort, it must be paired with a Phase I component (submitted as Phase 0/I), and applicants must clearly state the phase or device class of the proposed study.
The scope is broad across prostate cancer clinical management and care. While the mechanism clearly welcomes evaluations of new drugs, biologics, and devices, it also explicitly invites trials focused on survivorship, diet, quality of life, psychosocial interventions, and behavioral studies. Applications are strongly encouraged to address one of the FY11 PCRP overarching challenges; if they do not, they must make a convincing case that the work still targets a critical unmet need in prostate cancer research or patient care and that the results could drive major impact.
The application expectations are geared toward feasibility, rigor, and near-term execution. Applicants must explain why the proposed intervention could substantially improve treatment or management, and they must ground the intervention in a solid scientific rationale supported by careful analysis of existing literature. Preliminary data relevant to the trial are required, and any unpublished data must come from the PI or named collaborators. Proposals must also demonstrate access to an appropriate patient population and present a credible accrual plan, including discussion of how standards of care could influence enrollment or study design. In addition, applicants must document access to the study intervention and needed materials (for example, availability of the drug/compound or the device). The trial design must include clearly defined endpoints and a detailed statistical analysis plan with power calculations and sample size justification that directly match the study objectives.
Several requirements were highlighted as new for FY11. If applicable, the application must include documentation showing an existing Investigational New Drug (IND) application or Investigational Device Exemption (IDE). The program also requires applicants to explain how the clinical trial will be financed through completion, whether through PCRP funds, institutional backing, and/or additional external support; if other funding is part of the plan, documentation may be requested later for proposals recommended for funding. Another new element is a Transition Plan that lays out a practical pathway for continued development of the intervention after the award period ends, emphasizing that the program wants trials that do not stall after the initial DoD-funded phase.
From a compliance standpoint, human subjects oversight is central. Local Institutional Review Board (IRB) review is required for DoD-funded work involving human subjects or human anatomical substances, but IRB approval does not need to be in hand at the time of application submission. Separately, studies must undergo review by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO), which applies DoD-specific legal and regulatory requirements that can be more extensive than typical IRB documentation. Applicants are advised to plan for at least four months for these regulatory reviews and approvals. Operationally, the program expects the clinical trial to begin within 12 months of the award date, reinforcing the emphasis on readiness and speed.
Administratively, the opportunity (Funding Opportunity Number W81XWH 11 PCRP CTA) was posted May 5, 2011, with an application deadline of September 1, 2011, and an expected three awards totaling about $1.8 million. There is no cost-sharing requirement, eligibility is broadly open (unrestricted across entity types, subject to any specific eligibility notes in the full announcement), and the award instrument is listed as a cooperative agreement/grant under CFDA 12.420 (Military Medical Research and Development).
FAQs: DoD FY11 Prostate Cancer Research Program (PCRP) Clinical Trial Award
What is the DoD FY11 PCRP Clinical Trial Award?
The DoD FY11 Prostate Cancer Research Program (PCRP) Clinical Trial Award is a funding opportunity from the U.S. Army (USAMRAA) intended to support the rapid launch and execution of prostate cancer clinical trials. It focuses on testing novel interventions with strong potential to meaningfully change how prostate cancer is treated or managed.
What is the main purpose of this award mechanism?
The mechanism is designed to move quickly into patient enrollment and trial execution. Applications are expected to be mature and well-justified, rather than exploratory or primarily preclinical.
Is this award intended to support preclinical research?
No. The budget must be used to run a clinical trial and cannot support preclinical research.
How does the program define a clinical trial?
The program defines a clinical trial as a prospective study that accrues human participants and tests an intervention with measurable outcomes related to exploratory findings, safety, effectiveness, and/or efficacy.
What types of interventions can be tested in the trial?
Interventions may include drugs, devices, biologics, surgery, rehabilitation approaches, behavioral strategies, or similar approaches, as long as they are tested prospectively in human participants with measurable outcomes.
Which clinical trial phases are eligible for drug trials?
Eligible drug trial types include Phase 0/I, Phase I, Phase I/II, or Phase II.
Are exploratory Phase 0 studies allowed?
Yes, but an exploratory Phase 0 effort must be paired with a Phase I component and submitted as a Phase 0/I trial.
What device studies are eligible?
Eligible device trials include Class II or Class III device trials.
Do applicants need to state the phase or device class?
Yes. Applicants must clearly state the phase of the proposed drug study or the class of the proposed device trial.
What areas of prostate cancer research and care are within scope?
The scope is broad across prostate cancer clinical management and care. In addition to new drugs, biologics, and devices, the opportunity explicitly invites trials focused on survivorship, diet, quality of life, psychosocial interventions, and behavioral studies.
Do applications need to address FY11 PCRP overarching challenges?
Applications are strongly encouraged to address one of the FY11 PCRP overarching challenges. If an application does not address one, it must make a convincing case that it targets a critical unmet need in prostate cancer research or patient care and that results could drive major impact.
What level of readiness is expected for proposed trials?
The program emphasizes near-term execution and expects proposals to be ready to move quickly into patient enrollment, with rigorous planning and documentation to support feasibility.
What scientific rationale is expected in the application?
Applicants must explain why the intervention could substantially improve treatment or management and provide a solid scientific rationale supported by careful analysis of existing literature.
Is preliminary data required?
Yes. Preliminary data relevant to the proposed trial are required.
Can unpublished preliminary data be included?
Yes, but any unpublished data must come from the Principal Investigator (PI) or named collaborators.
What are the expectations for patient population access and enrollment?
Applicants must demonstrate access to an appropriate patient population and provide a credible accrual plan. The application should also discuss how standards of care could influence enrollment or the study design.
Do applicants need to document access to the intervention and materials?
Yes. Applicants must document access to the study intervention and any required materials, such as availability of a drug/compound or device.
What trial design and statistics information must be included?
The trial must include clearly defined endpoints and a detailed statistical analysis plan with power calculations and sample size justification that align with the study objectives.
Are IND or IDE documents required?
If applicable, the application must include documentation showing an existing Investigational New Drug (IND) application or Investigational Device Exemption (IDE).
Does the program require a plan for financing the trial through completion?
Yes. Applicants must explain how the clinical trial will be financed through completion, whether through PCRP funds, institutional support, and/or external support. If other funding is part of the plan, documentation may be requested later for proposals recommended for funding.
What is the Transition Plan requirement?
The application must include a Transition Plan describing a practical pathway for continued development of the intervention after the award period ends. This reflects the program goal of supporting trials that continue forward rather than stalling after the initial DoD-funded phase.
Is IRB approval required at the time of application submission?
Local Institutional Review Board (IRB) review is required for DoD-funded work involving human subjects or human anatomical substances, but IRB approval does not need to be in hand at the time of application submission.
Is there an additional DoD human subjects review beyond the local IRB?
Yes. Studies must also be reviewed by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO), which applies DoD-specific legal and regulatory requirements that can be more extensive than typical IRB requirements.
How long should applicants plan for regulatory reviews and approvals?
Applicants are advised to plan for at least four months for regulatory reviews and approvals.
How soon is the clinical trial expected to start after award?
The program expects the clinical trial to begin within 12 months of the award date.
How selective is this award?
The opportunity reflects a relatively selective history. At the time of the announcement, 97 applications had been received and 18 were recommended for funding, indicating that proposals are expected to be strong, mature, and execution-ready.
What is the funding opportunity number?
The Funding Opportunity Number is W81XWH 11 PCRP CTA.
When was the opportunity posted and what was the application deadline?
The opportunity was posted May 5, 2011, and the application deadline was September 1, 2011.
How many awards were expected and what was the approximate total funding?
The opportunity expected approximately three awards totaling about $1.8 million.
Is cost sharing required?
No. There is no cost-sharing requirement.
Who is eligible to apply?
Eligibility is broadly open (unrestricted across entity types), subject to any specific eligibility notes in the full announcement.
What is the award type/instrument?
The award instrument is listed as a cooperative agreement/grant.
What CFDA program is associated with this award?
The opportunity is associated with CFDA 12.420, Military Medical Research and Development.
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| DoD FY11 Prostate Cancer Research Program Impact Award Apply for W81XWH 11 PCRP IA Funding Number: W81XWH 11 PCRP IA Agency: Dept. of the Army USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
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