DoD Peer Reviewed Orthopaedic, Clinical Translational Research Award | W81XWH 19 PRORP CTRA

Opportunity Information: Apply for W81XWH 19 PRORP CTRA

The Department of Defense Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Translational Research Award (CTRA) is a funding opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) to push promising orthopaedic injury research into real-world clinical use. The award is meant for high-impact clinical research that is new, emerging, or otherwise positioned to change practice, even if it is not yet ready for a large, definitive randomized controlled trial. A central expectation is that projects will have a credible path to influencing the standard of care in the near term and over the long term, while also strengthening the evidence base used to build clinical guidelines for evaluation, treatment, and recovery in orthopaedic injuries affecting Service members, Veterans, and the broader public.

For the FY19 cycle, the CTRA emphasizes translation, meaning it is especially interested in moving techniques and interventions out of development and into clinical environments where they can help patients under military-relevant conditions. This includes care closer to the point of injury and situations where evacuation is delayed, which places unique constraints on diagnosis, stabilization, pain control, infection risk, and early rehabilitation decisions. Applications are expected to consider outcomes that matter to patients and operational readiness, such as overall health, functional performance, and quality of life after an orthopaedic injury. Alongside this translational focus, the program also aims to sharpen decision-making by identifying the most effective options for diagnosis, treatment, rehabilitation, and prevention, with usefulness not only to clinicians and patients but also to caregivers and policymakers who set standards and allocate resources.

In practical terms, the FY19 CTRA sits between exploratory clinical work and a full-scale trial. Unlike the separate PRORP Clinical Trial Award (CTA), which is restricted to clinical trials only, the CTRA allows a broader range of clinical research designs. Studies can be interventional and can include some retrospective data analysis, but the mechanism explicitly does not support projects that are purely retrospective or only based on database mining without a meaningful prospective or translational clinical component. Small pilot clinical trials involving human participants are allowed, reflecting the program’s intent to help teams generate the clinical feasibility, signals of benefit, and implementation insights often needed before launching a larger confirmatory trial. The opportunity uses the standard FY19 definition of a clinical trial: research where one or more human subjects are prospectively assigned to an intervention (including placebo or controls) to evaluate effects on biomedical or behavioral health outcomes.

The funding is strictly for clinical research and does not allow animal studies. Applicants who need animal research to advance their concept are directed instead to the PRORP Applied Research Award mechanism. Because the CTRA supports work that may involve investigational drugs or devices, applicants must plan for regulatory compliance. If a study uses a drug that is not FDA-approved for the proposed investigational use, an Investigational New Drug (IND) application under 21 CFR 312 may be required. Similarly, investigational devices may require an Investigational Device Exemption (IDE) under 21 CFR 812. The applicant is responsible for providing documentation from the Institutional Review Board (IRB) of record or the FDA showing whether an IND or IDE is required, and if required, the program expects submission to the FDA within 12 months of the award date. The government also reserves the right to withdraw funding if a necessary IND, IDE, or international regulatory submission is not made within that 12-month window, so regulatory strategy is a real make-or-break element rather than a formality.

Operationally, the award places strong emphasis on participant enrollment planning and accountability. Applications must lay out quarterly recruitment/enrollment targets across all sites in the Statement of Work, and awardees then work with USAMRAA to set formal recruitment milestones. Continued funding support is tied to making satisfactory progress against those milestones, which signals that the program prioritizes studies that are not only scientifically sound but also realistically executable in a clinical environment with credible access to participants and site capacity.

Eligibility for the opportunity is broadly open (unrestricted by organization type), and awards may be made as grants or cooperative agreements. For FY19, the opportunity number is W81XWH-19-PRORP-CTRA, under CFDA 12.420, with an anticipated small number of awards (listed as 3 expected awards in the source data). While the award ceiling is not specified in the provided listing (shown as 0), applicants should treat budget development as something that must be justified tightly around the clinical research plan, enrollment approach, and regulatory needs. The opportunity originally opened May 16, 2019 and closed September 18, 2019, reflecting the FY19 cycle timing.

Finally, every application must clearly explain why the work matters to military and/or Veteran populations affected by orthopaedic injury. The program encourages studies that include active duty Service members or Veterans as part of the participant population and also encourages collaboration with military and VA clinicians and researchers. In effect, the strongest submissions are those that combine practical clinical relevance, a plausible near-term pathway to adoption in military-relevant care settings, and a study design that generates actionable evidence that can shape guidelines and real clinical decisions.

• 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 Translational Research 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 May 16, 2019.
• Applicants must submit their applications by Sep 18, 2019. (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.

Apply for W81XWH 19 PRORP CTRA

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