DoD Peer Reviewed Orthopaedic, Clinical Translational Research Award | HT942524PRORPCTRA

Opportunity Information: Apply for HT942524PRORPCTRA

The DoD Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Translational Research Award (CTRA) is a Department of Defense grant opportunity focused on improving care for people with serious orthopaedic injuries, with a clear emphasis on problems that affect military readiness and the ability of Service Members to return to duty. The rationale behind the award is that extremity injuries make up a major share of combat-related trauma (about half of the injuries in the DoD Trauma Registry), and that non-combat orthopaedic injuries and chronic orthopaedic conditions from training, sports, or prior injuries are also a major readiness threat. The program highlights that earlier stabilization, treatment, and rehabilitation can reduce complications, lower morbidity, and help prevent limb loss, especially when orthopaedic care can be delivered quickly or close to the point of injury. While the PRORP prioritizes military relevance, the research it funds is expected to translate broadly to civilian patients as well, meaning the results should be applicable to anyone who has sustained a major orthopaedic injury.

This CTRA mechanism is meant to support high-impact, clinically oriented translational work that is not necessarily ready for a large, full-scale randomized controlled trial. The intent is to move promising techniques, tools, and interventions into real clinical settings and generate evidence that can shift standards of care over time. The program also pushes applicants to think holistically about outcomes, not just healing tissue or fixing a single clinical metric, but also improving overall health, functional ability, and quality of life after injury. Another key objective is practical decision support: identifying which diagnosis, treatment, rehabilitation, and prevention approaches work best so that patients, clinicians, caregivers, and policymakers have stronger evidence to guide real-world choices.

A central feature of the CTRA is flexibility around study design. Unlike the PRORP Clinical Trial Award (CTA), which is limited strictly to clinical trials, the CTRA can fund clinical research that may or may not include a clinical trial. At the same time, it is not an open door for purely retrospective studies. The announcement explicitly allows interventional work and permits some retrospective analysis as part of a broader project, and it allows small pilot clinical trials, but it does not allow projects that are purely retrospective or only based on databases. Importantly, funds must be used for clinical research and cannot be used for animal research.

The opportunity draws clear boundaries around what counts as clinical research for this mechanism. In scope are human-subjects studies involving direct interaction with participants or identifiable human-origin materials like data, tissues, and specimens, when the purpose is not to evaluate an intervention’s safety or efficacy. This includes patient-oriented research on mechanisms of human disease, diagnostic or detection approaches like biomarkers and imaging, health disparities work, and development of new technologies. Also included are epidemiologic and behavioral studies that do not evaluate intervention outcomes, along with outcomes research and health services research that do not meet the definition of a clinical trial. Excluded are in vitro studies using human tissues that cannot be linked back to a living person. In addition, studies that qualify for Common Rule exemption category 4 (secondary research where consent is not required) are not treated as clinical research under the CDMRP definition for this award, which matters for how the program evaluates fit.

Applications are expected to be ready for execution rather than speculative. Preliminary data are required and should directly support the feasibility and rationale of the proposed clinical research. Applicants also need to show they have access to an appropriate study population and can realistically meet enrollment or accrual goals, and they must describe how women and minorities will be included in a way that matches the scientific aims. There is an exception to that inclusion discussion when the study uses biospecimens or datasets that cannot be linked to individual identities or demographics (often the kind of work that is exempt from IRB review), because in those cases the demographic targeting is not feasible. If the research involves an intervention or investigational product, the proposal must document access to the needed drug, device, compound, or other materials for the full study period.

Because the award is designed to produce usable clinical evidence, the program places heavy emphasis on rigor in analysis and data handling. A clear statistical analysis plan is required, including power analysis and sample size projections tied to the study objectives. A data management plan is also required, including the use of an appropriate database that protects data integrity. If the work includes a clinical trial that needs oversight by a regulatory agency (such as the FDA), the data system must be compliant with 21 CFR Part 11 and use appropriate data standards. The program also flags regulatory responsibilities: if the project uses a drug not approved for the intended use in the country where the work will be conducted, an Investigational New Drug (IND) application (or equivalent) may be required under 21 CFR 312. Similarly, an Investigational Device Exemption (IDE) (or equivalent) may be required for devices under 21 CFR 812. When an IND or IDE is required, the applicant must submit it to the relevant regulatory agency within 12 months of the award start date, and the submission must match the specific product and indication being tested. If an IND or IDE is not required, the applicant is responsible for providing evidence from the IRB of record or the relevant regulatory agency to support that determination.

The program also signals interest in women’s health research, particularly work that addresses conditions affecting women uniquely, disproportionately, or differently than men, and it encourages analysis of sex as a biological variable. Applicants focused exclusively on women’s health are pointed toward a related PRORP Women’s Health Research Award mechanism as another possible fit. If the proposed project relies on Department of Defense or VA resources or databases, the application needs to describe the level of access already in place at submission and provide a plan to maintain that access throughout the project, since feasibility and continuity depend on it.

From a funding and administrative standpoint, this is a discretionary grant program managed by the Department of the Army, USAMRAA, under CFDA 12.420. Eligibility is listed as unrestricted. The mechanism is a grant under 31 USC 6304. For FY24, the anticipated maximum total cost for the full period of performance is up to $1.5 million per award. The program expects to allocate about $6.0 million total to make roughly four awards, though actual awards depend on federal funding availability and the outcomes of peer and programmatic review. The original closing date listed for applications was September 17, 2024, and awards supported with FY24 funds are expected to be made no later than September 30, 2025, with FY24 funds available for use until they expire on September 30, 2030.

One notable topical limitation is arthritis. Because a separate Arthritis Research Program was initiated, the FY24 PRORP notes it may not fund arthritis research itself. However, projects that involve conditions or health abnormalities related to arthritis can still be considered if they squarely address the PRORP-selected Focus Area for the application. In practice, this means applicants need to be careful about framing: arthritis cannot be the central target unless it fits within the allowed scope and the focus area is clearly driving the research question.

Overall, the CTRA is positioned for teams that already have early human data, can access the right patient population and clinical infrastructure, and want to translate a promising diagnostic, rehabilitation approach, clinical workflow, or emerging intervention into a well-controlled clinical study that is smaller than a definitive RCT but still strong enough to influence practice and guidelines for military, Veteran, and civilian orthopaedic care.

• 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 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 2024-05-09.
• Applicants must submit their applications by 2024-09-17. (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 4 candidate(s).
• Eligible applicants include: Unrestricted.

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