Opportunity Information: Apply for W81XWH 16 PRORP CTA
Apply for W81XWH 16 PRORP CTA
- 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 "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.
- This funding opportunity was created on Aug 02, 2016.
- Applicants must submit their applications by Dec 07, 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 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 Peer Reviewed Orthopaedic Clinical Trial Award (PRORP CTA), offered by the Department of Defense through the U.S. Army Medical Research Acquisition Activity (USAMRAA), is designed to fund the rapid launch and execution of human clinical trials that could meaningfully improve care for orthopaedic injuries affecting military personnel and Veterans. The program is focused on injuries tied directly to combat as well as non-battle orthopaedic injuries that still have a major effect on unit readiness and the ability of Service members to return to duty or work. Historically, the mechanism has been highly competitive: since it began in FY2009, 191 applications were received and 18 were recommended for funding. For the FY2016 cycle reflected in this notice (Funding Opportunity Number W81XWH 16 PRORP CTA), the DoD anticipated making about three awards. The opportunity is listed under CFDA 12.420 and uses grant and cooperative agreement funding instruments, with eligibility described as unrestricted (open to any entity type), subject to any additional eligibility language in the full announcement.
A central point of the award is that the money must directly support a clinical trial and cannot be used for preclinical or animal research. The announcement defines a clinical trial in a fairly standard way: a prospective study that enrolls human subjects and tests an intervention for measurable outcomes related to safety, effectiveness, and/or efficacy. Interventions can include drugs, devices, biologics, surgical procedures, rehabilitation approaches, behavioral interventions, or other modalities, as long as the study measures a direct effect of that intervention on the participant. Applicants are expected to use the DoD-provided human subjects guidance (referenced via the eBRAP Human Subject Resource Document) and to build their proposed work around real-world clinical execution rather than early laboratory development.
The scientific scope is intentionally broad in terms of trial stage and size. Proposed projects can range from smaller proof-of-concept and feasibility studies (including pilot, first-in-human, or Phase 0 style efforts) to larger, more definitive trials aimed at determining efficacy in relevant patient populations. Regardless of size, budgets are expected to be tightly justified and aligned with the actual scope and operational needs of the trial. While the award is open to many kinds of institutions, the program places strong emphasis on relevance to military and Veteran populations. Every application must clearly explain how the study addresses orthopaedic problems affecting these groups, and collaboration with military treatment facilities, Department of Veterans Affairs clinicians/researchers, or other military and VA partners is encouraged. The program also encourages, when feasible, enrollment that includes active duty Service members and/or Veterans as all or part of the study population.
Because many orthopaedic trials involve regulated products, the announcement lays out concrete expectations for FDA interaction and timelines. If the trial uses a drug that is not FDA-approved for the intended investigational use, an Investigational New Drug (IND) application compliant with 21 CFR 312 may be required, and it must be submitted to the FDA within six months of the award date. If the investigational product is a device, the applicant must show that an Investigational Device Exemption (IDE) submission compliant with 21 CFR 812 has been filed within six months of the award date, or provide evidence that the device is IDE-exempt. The government explicitly reserves the right to withdraw funding if an IND or IDE is required but not submitted within six months, or if documented IND/IDE status is not obtained within twelve months. In terms of operational startup, trials are expected to begin within twelve months of award, with an allowance of up to eighteen months for FDA-regulated studies.
The submission expectations read like a checklist for a trial that is ready to run. Preliminary data relevant to the proposed clinical trial is required, and the trial must be grounded in a sound scientific rationale supported by critical analysis of existing literature. Applicants are asked to think beyond the immediate study and describe the planned indication and product label goals when appropriate, along with an outline of the broader development plan and regulatory strategy to support that indication. A practical recruitment plan is also essential: the application should demonstrate access to an appropriate patient population, explain how enrollment targets will be met, and discuss how existing standards of care could influence accrual. Similarly, the applicant must document access to the intervention materials (drug, compound, device, or other), and the product quality must match applicable FDA manufacturing expectations such as Good Manufacturing Practices or the Quality System Regulation, depending on the product type and stage.
From a study quality standpoint, the DoD expects Good Clinical Practice alignment, clearly defined endpoints, and a rigorous analysis approach. Applications should include a statistical analysis plan, demonstrate appropriate statistical expertise on the team, and provide a power analysis with sample size projections that are sufficient to answer the study objectives. Data integrity is treated as a core requirement: applicants must present a data management plan and use an appropriate database, and FDA-regulated studies must comply with 21 CFR 11 for electronic records requirements. Safety and oversight are equally emphasized, with applicants required to spell out a safety management plan (including pharmacovigilance when applicable) and a clinical monitoring plan to ensure GCP compliance. The program also expects a study coordinator (or coordinators) who can shepherd the protocol through the Institutional Review Board process and any additional federal regulatory approvals, coordinate multi-site activities, and actively manage participant accrual. For studies judged by the IRB to be greater than minimal risk, the DoD requires an independent research monitor with expertise aligned to the risks in the project, consistent with DoD human research protection practices.
The award also prioritizes real-world transition and impact, not just publication. Applicants must include a Transition Plan describing how the intervention or product will move forward after the funded trial, whether that means the next clinical trial phase, further regulatory steps, adoption into clinical practice, or movement toward commercialization. Strong institutional support is required and should be explicitly documented in the application package. Finally, funded studies must be registered on ClinicalTrials.gov in line with NIH clinical trial registry expectations referenced in the general instructions.
For multi-institutional trials, the program adds additional operational and governance requirements. Applications should include clear plans for communication and data transfer among sites, and explain how specimens and imaging products will be managed across institutions. Importantly, multi-site efforts must also include an intellectual and material property plan that is agreed to by all participating institutions, signaling that the DoD wants partnering arrangements and ownership questions addressed up front rather than after the trial is underway. Overall, the PRORP CTA is aimed at clinical trials that are ready to start, tightly managed, and positioned to deliver actionable results that can improve surgical care and rehabilitation for orthopaedic injuries impacting military readiness and Veteran health.
Peer Reviewed Orthopaedic Clinical Trial Award (PRORP CTA) FAQs
1) What is the PRORP Clinical Trial Award (CTA)?
The Peer Reviewed Orthopaedic Clinical Trial Award (PRORP CTA) is a Department of Defense funding opportunity managed through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It is intended to fund the rapid launch and execution of human clinical trials that could meaningfully improve care for orthopaedic injuries affecting military personnel and Veterans.
2) Who is offering this funding opportunity?
The award is offered by the Department of Defense (DoD) through USAMRAA.
3) What is the Funding Opportunity Number for this notice?
The Funding Opportunity Number listed is W81XWH 16 PRORP CTA (FY2016 cycle).
4) What CFDA number is associated with this opportunity?
This opportunity is listed under CFDA 12.420.
5) What types of funding instruments are used?
The program uses grant and cooperative agreement funding instruments.
6) Who is eligible to apply?
Eligibility is described as unrestricted (open to any entity type), subject to any additional eligibility language included in the full announcement.
7) What is the main purpose of the award funding?
Funds must directly support a human clinical trial. The program is designed for trials that are ready to start and can be executed rapidly to generate actionable results relevant to orthopaedic care for Service members and Veterans.
8) Are preclinical, animal, or laboratory studies allowed under this award?
No. The award money must support a clinical trial and cannot be used for preclinical or animal research.
9) How does the announcement define a "clinical trial"?
A clinical trial is defined as a prospective study that enrolls human subjects and tests an intervention, measuring outcomes related to safety, effectiveness, and/or efficacy, including a direct effect of the intervention on the participant.
10) What kinds of interventions can be studied?
Interventions may include drugs, devices, biologics, surgical procedures, rehabilitation approaches, behavioral interventions, or other modalities, as long as the study measures a direct effect of that intervention on participants.
11) What injury areas and populations does PRORP CTA focus on?
The program focuses on orthopaedic injuries tied directly to combat as well as non-battle orthopaedic injuries that still significantly affect unit readiness and a Service member's ability to return to duty or work. Strong relevance to military and Veteran populations is required.
12) Is enrollment of active duty Service members and/or Veterans expected?
When feasible, the program encourages enrollment that includes active duty Service members and/or Veterans as all or part of the study population.
13) Are partnerships with military or VA organizations required?
Collaboration with military treatment facilities, Department of Veterans Affairs clinicians/researchers, or other military/VA partners is encouraged. Each application must clearly explain how the work addresses orthopaedic problems affecting military personnel and Veterans.
14) What trial stages are eligible (pilot vs. large trials)?
The scope is broad and can include smaller proof-of-concept and feasibility studies (including pilot, first-in-human, or Phase 0 style efforts) as well as larger, more definitive trials aimed at determining efficacy in relevant patient populations.
15) How competitive has this award historically been?
Historically, the mechanism has been highly competitive. Since FY2009, 191 applications were received and 18 were recommended for funding.
16) How many awards were anticipated for the FY2016 cycle in this notice?
For the FY2016 cycle reflected in this notice, the DoD anticipated making about three awards.
17) What are the expectations for budget planning?
Budgets are expected to be tightly justified and aligned with the actual scope and operational needs of the proposed clinical trial, regardless of the trial size.
18) What human subjects guidance should applicants follow?
Applicants are expected to use DoD-provided human subjects guidance referenced via the eBRAP Human Subject Resource Document.
19) What are the IND requirements and deadlines (for drugs)?
If the trial uses a drug that is not FDA-approved for the intended investigational use, an Investigational New Drug (IND) application compliant with 21 CFR 312 may be required. If required, it must be submitted to the FDA within six months of the award date.
20) What are the IDE requirements and deadlines (for devices)?
If the investigational product is a device, the application must show that an Investigational Device Exemption (IDE) submission compliant with 21 CFR 812 has been filed within six months of the award date, or provide evidence that the device is IDE-exempt.
21) Can the government withdraw funding based on IND/IDE status?
Yes. The government reserves the right to withdraw funding if an IND or IDE is required but not submitted within six months, or if documented IND/IDE status is not obtained within twelve months.
22) How quickly must the clinical trial begin after award?
Trials are expected to begin within twelve months of the award date. For FDA-regulated studies, there is an allowance of up to eighteen months.
23) Is preliminary data required?
Yes. Preliminary data relevant to the proposed clinical trial is required.
24) What kind of scientific rationale is expected?
The trial must be grounded in a sound scientific rationale supported by a critical analysis of existing literature.
25) Do applicants need to describe regulatory strategy and future development?
Yes. Applicants are asked to describe the planned indication and product label goals when appropriate, and to outline a broader development plan and regulatory strategy to support that indication.
26) What recruitment planning details should be included?
A practical recruitment plan is required. The application should demonstrate access to an appropriate patient population, explain how enrollment targets will be met, and discuss how existing standards of care could influence accrual.
27) Do applicants need to show access to the intervention materials?
Yes. Applicants must document access to the intervention materials (drug, compound, device, or other) needed for the trial.
28) Are there product quality/manufacturing expectations?
Yes. Product quality is expected to match applicable FDA manufacturing expectations, such as Good Manufacturing Practices (GMP) or the Quality System Regulation (QSR), depending on product type and stage.
29) What standards for trial conduct and quality are expected?
The DoD expects alignment with Good Clinical Practice (GCP), clearly defined endpoints, and a rigorous analysis approach.
30) Are a statistical plan and power analysis required?
Yes. Applications should include a statistical analysis plan, demonstrate appropriate statistical expertise on the team, and provide a power analysis with sample size projections sufficient to answer study objectives.
31) What are the data management and data integrity requirements?
Applicants must present a data management plan and use an appropriate database. For FDA-regulated studies, electronic records must comply with 21 CFR 11.
32) What safety oversight elements must be described?
Applicants must include a safety management plan (including pharmacovigilance when applicable) and a clinical monitoring plan to help ensure GCP compliance.
33) Is a study coordinator required?
The program expects a study coordinator (or coordinators) who can support IRB processing and any additional federal regulatory approvals, coordinate multi-site activities, and actively manage participant accrual.
34) When is an independent research monitor required?
For studies that an Institutional Review Board (IRB) judges to be greater than minimal risk, the DoD requires an independent research monitor with expertise aligned to the risks of the project, consistent with DoD human research protection practices.
35) Is ClinicalTrials.gov registration required?
Yes. Funded studies must be registered on ClinicalTrials.gov in line with NIH clinical trial registry expectations referenced in the general instructions.
36) What is a Transition Plan, and is it required?
A Transition Plan is required and should describe how the intervention or product will move forward after the funded trial. Examples include the next clinical trial phase, further regulatory steps, adoption into clinical practice, or movement toward commercialization.
37) Is institutional support required?
Yes. Strong institutional support is required and should be explicitly documented in the application package.
38) What extra requirements apply to multi-institutional (multi-site) trials?
Multi-site applications should include clear plans for communication and data transfer among sites, and explain how specimens and imaging products will be managed across institutions. They must also include an intellectual and material property plan agreed to by all participating institutions.
39) What is the program trying to achieve beyond publications?
The program emphasizes real-world transition and impact, aiming for results that can improve surgical care and rehabilitation for orthopaedic injuries affecting military readiness and Veteran health, with a clear path for what happens after the trial.
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