DoD Peer Reviewed Orthopaedic, Clinical Trial Award | W81XWH 20 PRORP CTA

Opportunity Information: Apply for W81XWH 20 PRORP CTA

The DoD Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award (CTA) is a Department of Defense funding opportunity meant to move quickly from promising ideas to real-world testing in people, specifically through human clinical trials. It focuses on interventions that could substantially improve outcomes for Service Members and Veterans with combat-related orthopaedic injuries, as well as non-battle orthopaedic injuries that still have a major effect on unit readiness and the ability to return to duty or work. A central theme is practicality and impact: applicants are pushed to show how their trial could support care closer to the point of injury and/or shorten the time it takes for injured personnel to recover and resume their roles.

This award is strictly for clinical trials, not general clinical research. In other words, the work must involve prospectively assigning human participants to one or more interventions (including placebo or control conditions when relevant) to measure biomedical or behavioral health-related outcomes. The mechanism can support a wide range of trial sizes and maturity levels, from small early-stage studies (such as pilot studies, first-in-human efforts, or Phase 0 style feasibility trials) to larger trials designed to determine efficacy in appropriate patient populations. The interventions themselves can also vary widely, including evaluation of new or improved products, drugs or biologics, medical devices, clinical guidance, and emerging technologies or approaches, as long as the project is truly a clinical trial and remains aligned with orthopaedic injury priorities tied to military needs. The CTA is explicitly contrasted with the PRORP Clinical Translational Research Award (CTRA): the CTRA can fund broader clinical research, while the CTA is limited to clinical trials only.

A notable feature is an added “Rehabilitation Option” tied to the Translation of Early Findings - Soft Tissue Trauma focus area. Applications in that area can request a higher funding level to support interdisciplinary projects that deliberately integrate surgical and rehabilitation strategies into a single, cohesive plan. The intent is to go beyond parallel efforts and instead combine approaches so the integrated strategy improves outcomes more than either component would alone. Surgical strategies can include reconstruction/repair and/or the use of biologics, pharmaceuticals, or devices aimed at restoring the native structure and function of traumatically injured tissues. Rehabilitation strategies are framed around restoring function and independence after injury or illness. Applicants pursuing this option must spell out the rehabilitation strategy and the relevant standard of care, and they are strongly encouraged to follow patients across the full continuum of care. Collaboration is not optional here: the team must include at least one investigator with orthopaedic rehabilitation expertise and at least one orthopaedic/trauma care clinician (credentialed and actively practicing), and letters of collaboration from both the rehab specialist and the surgeon/trauma clinician are required.

The opportunity places heavy emphasis on readiness to execute. Preliminary data that directly supports the proposed trial is required, and the trial is expected to start within 12 months of the award date, which signals that the program is prioritizing projects that are already well-developed rather than early brainstorming. Applicants need to show that the intervention has a strong scientific rationale grounded in a thoughtful review of existing literature, and they are expected to articulate objectives and endpoints that are clearly defined and aligned with Good Clinical Practice (GCP). Practical trial operations matter just as much as scientific novelty: proposals must demonstrate access to an adequate patient population, explain how recruitment targets will be met, and discuss how existing standards of care might affect enrollment or interpretation of results. The program also expects a serious statistical foundation, including a power analysis, sample size justification, and appropriate statistical expertise on the team.

Because many orthopaedic trials involve regulated products, the announcement lays out regulatory expectations clearly. If the trial uses a drug that is not FDA-approved for the intended investigational use, an Investigational New Drug (IND) application may be required under 21 CFR 312. If a device is being studied, an Investigational Device Exemption (IDE) may be required under 21 CFR 812, or the applicant must document why an IDE is not required or why an abbreviated IDE applies. For international trial sites, the relevant host-country regulatory submissions are also required when applicable. A major compliance pressure point is timing: if an IND, IDE, and/or international regulatory application is required, it must be submitted within 6 months of the award date, and the government explicitly reserves the right to withdraw funding if required submissions are not made on time. Applicants are also expected to show they can obtain and supply the investigational product for the duration of the study, with documentation of quality and stability consistent with applicable FDA manufacturing expectations (such as GMP and other quality system standards, depending on product type and stage). The announcement also asks teams to reflect experience working with the FDA, including prior submissions when relevant, which reinforces that the program is looking for teams capable of navigating regulated clinical development.

Operational oversight and transparency are built into the award requirements. Awardees will work with CDMRP and USAMRAA to set human subject recruitment milestones, and continued support depends on meeting those milestones satisfactorily. Applications are expected to include robust infrastructure plans: data management (including use of appropriate databases to protect data integrity and, when FDA-regulated, use of 21 CFR 11-compliant systems and appropriate data standards), safety management and pharmacovigilance approaches as applicable, and a clinical monitoring plan for GCP compliance. The program also expects applicants to include dedicated study coordination capacity to manage IRB and other regulatory approvals, coordinate multi-site activities, and drive participant accrual. On the public accountability side, funded studies must be registered on ClinicalTrials.gov prior to starting, and awardees must post the IRB-approved informed consent form on a publicly available federal website as required under 32 CFR 219.

Another consistent theme is what happens after the trial ends. Applicants must include a transition plan describing how the product or approach will move forward after the CTA period, whether that means progressing to the next phase of clinical trials, securing follow-on funding, or moving toward broader implementation or commercialization. The application also needs to show strong institutional support, and when relevant, a clear commitment and capability to serve as the FDA regulatory sponsor and fulfill sponsor responsibilities (for example, those described in 21 CFR 312, Subpart D).

In terms of funding structure and scale, awards are made as assistance agreements, meaning they can be issued either as grants or cooperative agreements depending on how much involvement the DoD expects to have during project performance. Total costs over the entire period of performance are capped at $2.25 million for Funding Level 1 and $2.75 million for Funding Level 2 (the level associated with the Rehabilitation Option). For FY20, the program expected to allocate about $9 million to fund roughly four Level 1 awards and about $5.5 million to fund roughly two Level 2 awards, for an anticipated total of about six awards, although final funding depends on federal funds availability and the outcomes of scientific and programmatic review. Eligibility is listed as unrestricted (open to many entity types, subject to any specific clarifications in the announcement). The opportunity was managed by the Department of Defense, Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), under Funding Opportunity Number W81XWH-20-PRORP-CTA, originally posted March 16, 2020, with an original closing date of September 10, 2020, and awards planned no later than September 30, 2021. The FY20 funds associated with these awards were anticipated to remain available for use until September 30, 2026, which sets an outer boundary on the life of the funding even though the project period and expenditure timing are governed by the award’s negotiated terms.

• 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 "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.
• This funding opportunity was created on Mar 16, 2020.
• Applicants must submit their applications by Sep 10, 2020. (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 6 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.

Apply for W81XWH 20 PRORP CTA

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