Opportunity Information: Apply for W81XWH 14 PCRP CEA
Apply for W81XWH 14 PCRP CEA
- 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 Exploration 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 30, 2014 and posted on May 30, 2014.
- Applicants must submit their applications by Oct 29, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,200,000.00 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 Prostate Cancer Clinical Exploration Award (CEA) is a Prostate Cancer Research Program (PCRP) funding mechanism run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) that is meant to push bold, hypothesis-driven ideas into early clinical testing. The central goal is to support proof-of-principle clinical studies that could break through current clinical barriers in prostate cancer and, if successful, quickly justify larger, efficacy-focused trials that could change standard clinical care. The program is explicitly aimed at "outside the box" approaches, meaning applicants need to show why the intervention or study goes beyond conventional prostate cancer therapeutics or management strategies. Importantly, the opportunity is not for preclinical-only work; it is for human clinical trials and/or clinical trial-associated correlative studies.
On the clinical trial side, the award supports early phase trials including Phase 0, Phase I, or pilot Phase II studies for drugs or drug combinations, as well as Class II or III device studies, along with other early clinical testing models that fit the program definition of a clinical trial. The announcement uses a standard definition: a prospective study that accrues human subjects and tests an intervention (such as a drug, biologic, device, surgery, behavioral intervention, or other modality) with measurable outcomes related to exploratory signals, safety, effectiveness, and/or efficacy. Applicants proposing anything that is purely preclinical are directed to other funding mechanisms instead, since CEA funds must be tied to clinical testing in humans.
The award also funds correlative studies, but only when they are clearly linked to an ongoing or completed clinical trial that is supported by another funding source. These correlative projects must be hypothesis-based and innovative, and they should be positioned to meaningfully inform clinical decision-making in prostate cancer. Examples include biomarker analyses for prognosis or prediction of response, investigations of mechanism of action or resistance, immune response analyses connected to progression or treatment outcomes, and tumor antigen characterization that could enable new or improved therapies. The expectation is that these correlative results will help identify which patients benefit from which approaches, clarify biological effects of interventions in prostate cancer, or otherwise strengthen clinical management strategies.
From an eligibility and compliance standpoint, the opportunity (Funding Opportunity Number W81XWH-14-PCRP-CEA) is described as unrestricted in terms of applicant entity type, with any limits only if clarified elsewhere in the full announcement. It is offered as a grant/cooperative agreement in the Science and Technology/Research and Development category (CFDA 12.420, Military Medical Research and Development), with no cost sharing requirement. For this cycle, the estimated total funding was $2.2 million with an expectation of about three awards, and the posting and closing dates were May 30, 2014 and October 29, 2014, respectively (now archived). Even though the dollar ceiling and floor are listed as $0 in the summary fields, the narrative makes clear that awards were intended and capped in practice by the total available funds and the number of anticipated awards.
Applications are expected to be clinically ready and operationally realistic. Submissions must clearly state what kind of clinical trial is proposed and its phase (or device class), and they must include solid scientific justification built from critical literature review plus preliminary data. The program emphasizes statistical rigor: applicants should provide statistically supported preclinical evidence that warrants clinical testing, a clear statistical analysis plan, appropriate statistical expertise on the team, and a power analysis with defensible sample size projections aligned to the study endpoints and objectives. Applicants must also show they can actually run the study, including documented access to a suitable patient population, a credible recruitment/accrual plan, and consideration of how standards of care could affect enrollment and feasibility. They must also demonstrate access to the drug, compound, device, or other required materials, with product quality consistent with applicable FDA manufacturing expectations (for example, GMP or device Quality System Regulation standards as appropriate).
Regulatory expectations are a major feature of this mechanism. If the clinical trial uses a drug not FDA-approved for the proposed investigational use, the applicant needs to show that an Investigational New Drug (IND) application under 21 CFR 312 has been submitted, or will be submitted, within 60 days of the DoD award date. Similarly, for devices, the applicant must show that an Investigational Device Exemption (IDE) under 21 CFR 812 has been submitted or will be submitted within 60 days of award, or provide documentation that the device is IDE-exempt. The government explicitly reserves the right to withdraw funding if the IND/IDE is not submitted within 60 days of award or if documented IND/IDE status is not obtained within six months. Operationally, the award also expects that the clinical trial will begin within 12 months after the award date, reinforcing that this program is for projects ready to move quickly.
Programmatically, applicants are expected to address at least one PCRP focus area and are strongly encouraged to address one of the PCRP overarching challenges. If a proposal does not map to an overarching challenge, the applicant must make a compelling case that the work still addresses a critical unmet need in prostate cancer clinical management. Finally, the application must include a Transition Plan that spells out how the intervention or product will progress to the next clinical trial phase, including likely funding sources and resources. In other words, the CEA is designed as a launchpad: it funds early human testing or high-value correlative work with the expectation that successful results will rapidly translate into larger, more definitive trials.
DoD Prostate Cancer Clinical Exploration Award (CEA) - FAQs
What is the DoD Prostate Cancer Clinical Exploration Award (CEA)?
The DoD Prostate Cancer Clinical Exploration Award (CEA) is a funding mechanism within the Prostate Cancer Research Program (PCRP), administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It is designed to move bold, hypothesis-driven ideas into early clinical testing in humans.
What is the main purpose of the CEA?
The central goal is to support proof-of-principle clinical studies intended to break through current clinical barriers in prostate cancer. If successful, the results should quickly justify larger, efficacy-focused trials that could ultimately change standard clinical care.
Is this award meant for conventional prostate cancer approaches?
No. The CEA is explicitly aimed at "outside the box" approaches. Applicants are expected to explain why their proposed intervention or study goes beyond conventional prostate cancer therapeutics or management strategies.
Does the CEA support preclinical-only research?
No. This opportunity is not for preclinical-only work. CEA funds must be tied to clinical testing in humans (clinical trials) and/or clinical trial-associated correlative studies connected to an ongoing or completed clinical trial.
What kinds of clinical trials are supported?
The CEA supports early phase clinical trials, including Phase 0, Phase I, and pilot Phase II studies for drugs or drug combinations. It also supports Class II or Class III device studies, along with other early clinical testing models that meet the program definition of a clinical trial.
How does the announcement define a clinical trial?
A clinical trial is defined as a prospective study that accrues human subjects and tests an intervention (for example, a drug, biologic, device, surgery, behavioral intervention, or other modality) with measurable outcomes related to exploratory signals, safety, effectiveness, and/or efficacy.
Are correlative studies allowed under this award?
Yes, but only when they are clearly linked to an ongoing or completed clinical trial that is supported by another funding source. Correlative projects must be hypothesis-based, innovative, and positioned to meaningfully inform clinical decision-making in prostate cancer.
What are examples of correlative studies that fit this mechanism?
Examples include biomarker analyses for prognosis or prediction of response, studies of mechanism of action or resistance, immune response analyses linked to progression or treatment outcomes, and tumor antigen characterization that could enable new or improved therapies.
What is the expectation for how correlative results will be used?
The expectation is that correlative findings will help identify which patients benefit from which approaches, clarify biological effects of interventions in prostate cancer, or otherwise strengthen clinical management strategies.
Who can apply (eligibility)?
The opportunity is described as unrestricted in terms of applicant entity type, with any limits only if clarified elsewhere in the full announcement.
What is the Funding Opportunity Number for this award?
The Funding Opportunity Number is W81XWH-14-PCRP-CEA.
What type of funding mechanism is this?
It is offered as a grant/cooperative agreement in the Science and Technology/Research and Development category.
What CFDA program is associated with this opportunity?
The listing provided is CFDA 12.420, Military Medical Research and Development.
Is cost sharing required?
No cost sharing requirement is stated for this opportunity.
How much funding was available and how many awards were anticipated?
For the referenced cycle, the estimated total funding was $2.2 million, with an expectation of about three awards.
Why do the summary fields list $0 for award ceiling/floor?
Even though the summary fields list the ceiling and floor as $0, the narrative indicates that awards were intended and were practically constrained by the total available funds and the anticipated number of awards.
What were the posting and closing dates for the referenced cycle?
The posting date was May 30, 2014 and the closing date was October 29, 2014. The opportunity is described as archived.
How "ready" does a project need to be?
Applications are expected to be clinically ready and operationally realistic. Proposals should show they can move quickly into human clinical testing and actually execute the study as proposed.
Do applicants need to specify the clinical trial phase or device class?
Yes. Submissions must clearly state what kind of clinical trial is proposed and its phase (or, for devices, the device class).
What scientific support is expected in the application?
Applicants are expected to provide a solid scientific justification built from a critical literature review plus preliminary data. The program also emphasizes that preclinical evidence supporting clinical testing should be statistically supported.
What statistical requirements are emphasized?
The announcement emphasizes statistical rigor, including a clear statistical analysis plan, appropriate statistical expertise on the team, and a power analysis with defensible sample size projections aligned with endpoints and objectives.
What operational feasibility information should be included?
Applicants should document access to a suitable patient population, provide a credible recruitment/accrual plan, and address how standards of care could affect enrollment and feasibility.
Do applicants need access to the study drug/device/materials?
Yes. Applicants must demonstrate access to the drug, compound, device, or other required materials.
Are there manufacturing or quality expectations for products used in the trial?
Yes. Product quality is expected to be consistent with applicable FDA manufacturing expectations, such as GMP for drugs or Quality System Regulation standards for devices, as appropriate.
What are the IND requirements for drug trials?
If the clinical trial uses a drug that is not FDA-approved for the proposed investigational use, the applicant must show that an IND under 21 CFR 312 has been submitted, or will be submitted, within 60 days of the DoD award date.
What are the IDE requirements for device studies?
For devices, the applicant must show that an IDE under 21 CFR 812 has been submitted or will be submitted within 60 days of award, or provide documentation that the device is IDE-exempt.
Can funding be withdrawn based on IND/IDE status?
Yes. The government reserves the right to withdraw funding if the IND/IDE is not submitted within 60 days of award or if documented IND/IDE status is not obtained within six months.
How soon is the clinical trial expected to begin after award?
The award expects the clinical trial to begin within 12 months after the award date, reinforcing that this mechanism targets projects ready to move quickly.
Do proposals need to align with PCRP focus areas and challenges?
Yes. Applicants are expected to address at least one PCRP focus area and are strongly encouraged to address one of the PCRP overarching challenges.
What if a proposal does not map to a PCRP overarching challenge?
If a proposal does not map to an overarching challenge, the applicant must make a compelling case that the work still addresses a critical unmet need in prostate cancer clinical management.
What is the Transition Plan requirement?
The application must include a Transition Plan describing how the intervention or product will progress to the next clinical trial phase, including likely funding sources and resources. The CEA is intended to serve as a launchpad to larger, more definitive trials if early results are promising.
What is the overall "translation" expectation of this award?
The CEA is structured to fund early human testing or high-value correlative work with the expectation that successful results will rapidly translate into larger, efficacy-focused trials that could impact clinical care.
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