Opportunity Information: Apply for W81XWH 15 PRORP CTA
Apply for W81XWH 15 PRORP 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 Peer Reviewed Orthopaedic 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 Jun 30, 2015 and posted on Jun 30, 2015.
- Applicants must submit their applications by Nov 19, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $6,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 2 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 Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award is a U.S. Army medical research funding opportunity meant to move orthopaedic clinical trials into action quickly, with a clear focus on problems that affect Service members and Veterans. The central goal is practical impact: studies should address combat-related orthopaedic injuries or non-battle orthopaedic injuries that still meaningfully reduce unit readiness and slow return to duty or work. The award is built for trials that can change clinical practice, improve outcomes, or accelerate the path toward usable products and guidance in military-relevant settings.
Projects funded under this mechanism must be true clinical trials, meaning they prospectively enroll human participants and test an intervention to measure outcomes tied to safety, effectiveness, efficacy, or other measurable clinical effects. Interventions can include drugs or biologics, medical devices, surgical procedures, rehabilitation approaches, behavioral interventions, clinical guidance, or other emerging technologies. What is not allowed is preclinical or lab-only work; the funding has to support a human study. Applicants proposing earlier-stage, non-human research are expected to pursue other funding mechanisms instead. Every application also has to clearly explain how the work is relevant to military and/or Veteran populations affected by orthopaedic injury, and while collaboration with military clinicians and researchers is encouraged, the key expectation is that the trial population and outcomes make sense for the military context. Trials that include active duty Service members or Veterans as part or all of the study population are viewed as aligned with the program intent.
The program supports a wide range of trial sizes and phases, from smaller proof-of-concept or feasibility studies (including pilot, first-in-human, or Phase 0-type efforts) to larger trials designed to determine efficacy in patient populations that reflect real clinical needs. A practical budgeting point is emphasized: proof-of-concept projects are not expected to request the maximum amount, and all budgets should be tightly justified relative to scope. Overall, the mechanism is trying to fund trials that are ready to start, grounded in real clinical access, and designed to produce interpretable outcomes rather than exploratory work that is still too early for human testing.
Regulatory readiness is a major requirement when investigational products are involved. If the trial uses a drug that is not FDA-approved for the intended investigational use, an Investigational New Drug (IND) submission under 21 CFR 312 may be required, and it must be submitted to the FDA within six months of the award date. For investigational devices, the award requires evidence that an Investigational Device Exemption (IDE) submission under 21 CFR 812 has been filed within six months of the award date, or documentation that the device is IDE-exempt. The government also reserves the right to withdraw funding if an IND or IDE is necessary but was not submitted by the application deadline, or if documented status is not obtained within six months after award, which signals that applicants need to be thinking about regulatory pathways early, not after funding arrives.
Operationally, timelines and execution planning are treated as make-or-break elements. The clinical trial is expected to begin within 12 months of the award date, extended to 18 months for FDA-regulated studies, reflecting the reality of added regulatory steps. Applications must include preliminary data relevant to the proposed study and present a sound scientific rationale supported by a careful review of the literature. Applicants are also expected to describe, when appropriate, the planned label indication for the product and outline a realistic development plan needed to support that indication, which pushes investigators to show a credible path from trial results to the next stage of clinical development or implementation.
Because recruitment and execution often determine whether trials succeed, the announcement requires a clear demonstration of access to an appropriate patient population and a convincing accrual plan, including how standards of care might affect who is eligible and how outcomes are interpreted. Applicants also need to document availability and access to the intervention materials (drug, device, or other), and the product quality needs to match FDA manufacturing expectations that fit the product type and development stage, such as Good Manufacturing Practices or the Quality System Regulation. Trial design expectations include clearly defined endpoints, adherence to Good Clinical Practice (GCP), an explicit statistical analysis plan with qualified statistical expertise, and a power analysis that supports the proposed sample size and the ability to answer the study objectives.
The award also places strong emphasis on trial infrastructure and oversight. Applications must lay out a data management plan and use an appropriate database to protect data integrity, a safety management plan describing pharmacovigilance as applicable, and a clinical monitoring plan describing how GCP compliance will be ensured across sites. A study coordinator (or coordinators) is required to manage protocol movement through the Institutional Review Board (IRB) and any additional federal regulatory processes, coordinate multi-site activity when relevant, and support participant recruitment and retention. Applicants must also provide a Transition Plan that explains how the product or approach will advance after the award, whether that means moving into the next trial phase, securing follow-on funding, or progressing toward market delivery and real-world use. Strong institutional support must be evident in the application, and awardees are expected to register the study on ClinicalTrials.gov, aligning with federal expectations for transparency in clinical research.
From an administrative standpoint, this opportunity was offered by the Department of the Army (USAMRAA) under Funding Opportunity Number W81XWH-15-PRORP-CTA as a discretionary research and development program (CFDA 12.420, Military Medical Research and Development). It used cooperative agreement and grant instruments, did not require cost sharing, and anticipated making two awards from an estimated total funding pool of $6,000,000. Eligibility was listed as unrestricted, meaning a broad range of organizations could apply as long as they met the specific requirements described in the announcement. The posting date was June 30, 2015, with an application closing date of November 19, 2015, and the opportunity is archived, but the requirements and structure provide a clear picture of what DoD orthopaedic clinical trial funding tends to prioritize: military-relevant impact, readiness to execute, regulatory and operational realism, and a credible path to the next step after the trial ends.
FAQs: DoD PRORP Clinical Trial Award (W81XWH-15-PRORP-CTA)
1) What is this funding opportunity?
The Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award is a U.S. Army medical research funding opportunity designed to move orthopaedic clinical trials into action quickly, with an emphasis on practical impact for Service members and Veterans.
2) What is the main goal of the PRORP Clinical Trial Award?
The central goal is to fund clinical trials that can change clinical practice, improve outcomes, or speed development of usable products or guidance in military-relevant settings. The focus is on orthopaedic problems that affect Service members and Veterans, including injuries that reduce unit readiness and delay return to duty or work.
3) What types of injuries does the program prioritize?
The program prioritizes studies addressing combat-related orthopaedic injuries as well as non-battle orthopaedic injuries that still meaningfully reduce unit readiness and slow return to duty or work.
4) Does the proposed study have to be a true clinical trial?
Yes. Projects funded under this mechanism must be clinical trials that prospectively enroll human participants and test an intervention to measure outcomes related to safety, effectiveness, efficacy, or other measurable clinical effects.
5) What kinds of interventions can be tested?
Allowable interventions include drugs or biologics, medical devices, surgical procedures, rehabilitation approaches, behavioral interventions, clinical guidance, and other emerging technologies, as long as the work is a human clinical trial.
6) What is not allowed under this award?
Preclinical or lab-only work is not allowed. Studies that are earlier-stage and do not involve enrolling human participants are expected to use other funding mechanisms instead.
7) How important is military or Veteran relevance?
Military and/or Veteran relevance is a core requirement. Each application must clearly explain how the work is relevant to military and/or Veteran populations affected by orthopaedic injury. Trials that include active duty Service members or Veterans as part or all of the study population are aligned with program intent.
8) Is collaboration with military clinicians or researchers required?
Collaboration with military clinicians and researchers is encouraged. The key expectation is that the trial population and outcomes make sense for the military context.
9) What trial sizes or phases are supported?
The program supports a wide range, from smaller proof-of-concept or feasibility trials (including pilot, first-in-human, or Phase 0-type efforts) to larger trials designed to determine efficacy in clinically relevant patient populations.
10) Are there budgeting expectations for proof-of-concept trials?
Yes. Proof-of-concept projects are not expected to request the maximum award amount, and all budgets should be tightly justified relative to scope.
11) What does the program mean by being "ready to start"?
The mechanism is aimed at trials that are ready to execute, have real clinical access to the target population, and are designed to produce interpretable outcomes (not exploratory work that is too early for human testing).
12) What are the regulatory requirements if the study uses an investigational drug?
If the trial uses a drug that is not FDA-approved for the intended investigational use, an Investigational New Drug (IND) submission under 21 CFR 312 may be required. If required, it must be submitted to the FDA within six months of the award date.
13) What are the regulatory requirements if the study uses an investigational device?
For investigational devices, the award requires evidence that an Investigational Device Exemption (IDE) submission under 21 CFR 812 has been filed within six months of the award date, or documentation that the device is IDE-exempt.
14) Can funding be withdrawn due to IND or IDE issues?
Yes. The government reserves the right to withdraw funding if an IND or IDE is necessary but was not submitted by the application deadline, or if documented status is not obtained within six months after the award date.
15) When is the clinical trial expected to begin after award?
The clinical trial is expected to begin within 12 months of the award date. For FDA-regulated studies, this timeline is extended to 18 months to account for additional regulatory steps.
16) Is preliminary data required?
Yes. Applications must include preliminary data relevant to the proposed study and provide a sound scientific rationale supported by a careful review of the literature.
17) Does the application need to describe a path beyond the funded trial?
Yes. Applicants are expected to describe, when appropriate, the planned label indication for the product and outline a realistic development plan needed to support that indication. A Transition Plan is also required to explain how the product or approach will advance after the award.
18) What is the Transition Plan expected to cover?
The Transition Plan should explain what happens after the award, such as progressing to the next clinical trial phase, securing follow-on funding, moving toward market delivery, or supporting real-world use and implementation.
19) What are the expectations for recruitment and accrual planning?
Applications must clearly demonstrate access to an appropriate patient population and provide a convincing accrual plan. The plan should address how standards of care may affect eligibility and how outcomes will be interpreted.
20) Do applicants need to show they have access to the intervention materials?
Yes. Applicants must document availability and access to the intervention materials (such as the drug, device, or other intervention).
21) Are there product quality or manufacturing expectations?
Yes. Product quality should match FDA manufacturing expectations appropriate to the product type and development stage, such as Good Manufacturing Practices (GMP) or the Quality System Regulation (QSR).
22) What trial design elements are expected?
Applications are expected to include clearly defined endpoints, adherence to Good Clinical Practice (GCP), an explicit statistical analysis plan supported by qualified statistical expertise, and a power analysis that justifies the proposed sample size and ability to answer the objectives.
23) What are the data management expectations?
A data management plan is required, including use of an appropriate database to protect data integrity.
24) What safety oversight planning is required?
A safety management plan is required, including pharmacovigilance as applicable.
25) Is a clinical monitoring plan required?
Yes. A clinical monitoring plan must be included to describe how GCP compliance will be ensured across sites.
26) Is a study coordinator required?
Yes. A study coordinator (or coordinators) is required to manage protocol movement through the Institutional Review Board (IRB) and any additional federal regulatory processes, coordinate multi-site activities when relevant, and support recruitment and retention.
27) Is ClinicalTrials.gov registration required?
Yes. Awardees are expected to register the study on ClinicalTrials.gov, consistent with federal expectations for transparency in clinical research.
28) What agency administered this opportunity and what is the funding opportunity number?
This opportunity was offered by the Department of the Army (USAMRAA) under Funding Opportunity Number W81XWH-15-PRORP-CTA.
29) What program and CFDA number is associated with this funding?
It was offered as part of a discretionary research and development program under CFDA 12.420, Military Medical Research and Development.
30) What funding instruments were used?
The opportunity used cooperative agreement and grant instruments.
31) Was cost sharing required?
No. The announcement stated that cost sharing was not required.
32) How many awards and how much total funding were anticipated?
The announcement anticipated making two awards from an estimated total funding pool of $6,000,000.
33) Who was eligible to apply?
Eligibility was listed as unrestricted, meaning a broad range of organizations could apply as long as they met the specific requirements described in the announcement.
34) What were the posting and closing dates?
The posting date was June 30, 2015, and the application closing date was November 19, 2015.
35) Is this opportunity still open?
No. The opportunity is archived.
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