DOD Peer Reviewed Orthopaedic, Clinical Trial Award | HT9425 23 PRORP CTA

Opportunity Information: Apply for HT9425 23 PRORP CTA

The DOD Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award is a Department of Defense funding opportunity focused on getting high-impact orthopaedic clinical trials up and running quickly, with an emphasis on problems that directly affect military readiness and a service member's ability to return to duty or work. The rationale is straightforward: musculoskeletal and extremity injuries are a major share of combat trauma (about half of the injuries captured in the DOD Trauma Registry), and non-combat injuries from training, overuse, recreation, or prior injury are also a major readiness drain. The program is looking for studies that can improve early stabilization, treatment, and rehabilitation, ideally helping care happen closer to the point of injury and reducing complications, morbidity, and limb loss. Although the military context is central, the intent is to fund research that can improve outcomes for anyone who has suffered major musculoskeletal injury.

This award mechanism is strictly for clinical trials in humans, not animal studies, benchtop work, or other preclinical development. In PRORP terms, this Clinical Trial Award (CTA) is narrower than the Clinical Translational Research Award (CTRA): the CTA is only for projects that meet the formal definition of a clinical trial, meaning human subjects are prospectively assigned to one or more interventions (including placebo or control conditions) to evaluate effects on biomedical or behavioral health-related outcomes. A key point is that projects that do not measure safety, effectiveness, and/or efficacy outcomes of an intervention do not qualify as clinical trials under this announcement. The scope of allowable interventions is broad as long as it is trial-ready: the DOD is open to studies of new products, drugs or biologics, devices, clinical guidance, and emerging approaches or technologies. The trial itself can range from smaller proof-of-concept efforts (including pilot studies, first-in-human work, and phase 0-type trials) to larger trials designed to determine efficacy in the target patient population.

The announcement lays out two research levels. Research Level 1 is available to all applications submitted under the program announcement regardless of the chosen focus area. A specialized Research Level 2 "Collaborative Care Option" is available only for applications submitted under the Translation of Early Findings - Soft Tissue Trauma focus area, and it is designed to push truly interdisciplinary work that blends surgical and rehabilitation strategies into one cohesive project. In practical terms, the DOD is signaling that it wants integrated care pathways rather than isolated silo solutions: surgical strategies can include reconstruction/repair and/or use of biologics, pharmaceuticals, or devices to restore native tissue structure and function, while rehabilitative strategies focus on restoring function and independence after injury. For the Collaborative Care Option, applicants must spell out the rehabilitation strategy and the standard of care, and studies that follow patients across the continuum of care are especially encouraged. To keep collaborations real rather than nominal, the project team must include at least one investigator with orthopaedic rehabilitation expertise and at least one clinician specializing in orthopaedic or trauma care, and letters of collaboration from both specialists are required.

Because many orthopaedic interventions intersect with regulated drugs and devices, the opportunity includes explicit regulatory expectations. If a proposed intervention is a drug being used in a way not approved by the FDA, an Investigational New Drug (IND) application may be required under 21 CFR 312. If it is a device, 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 is appropriate). For trials conducted at international sites with investigational products, the relevant host-country regulatory submissions are also required. A firm compliance timeline is built in: if an IND, IDE, or international regulatory submission is necessary, it must be submitted within 6 months of the award date, and the government reserves the right to withdraw funding if those submissions are required but not made on time. FDA-regulated studies are given a bit more runway on startup timing, but not on the 6-month regulatory submission expectation.

Operationally, the DOD wants these trials to start quickly and be feasible on day one. Trials are expected to begin within 12 months of the award date, or within 18 months for FDA-regulated studies. Preliminary data are not optional; applicants must include preliminary data relevant to the proposed trial. The application must also demonstrate access to a suitable patient population and provide a realistic accrual plan that can support meaningful outcomes, including an approach to enrolling women and minorities consistent with the study objectives. Similarly, applicants must document intervention availability, meaning they have credible access to the drug, biologic, device, or other materials for the full duration of the study.

The announcement also puts strong weight on execution capability, not just scientific ideas. Applicants are expected to show that the team has real clinical trial experience, including expertise in statistics, data management, and FDA processes where applicable. The proposal should identify study coordination capacity to shepherd the protocol through the IRB and any other required federal approvals, coordinate multi-site activity if relevant, and manage participant accrual. Institutional support matters as well, particularly if the institution will serve as the FDA regulatory sponsor, since that role carries specific sponsor responsibilities under federal regulations. On the technical side, applications must include a clear statistical analysis plan, a power analysis supporting sample size projections, and a data management plan with an appropriate database to protect data integrity. Where required by a regulatory agency, the trial must use a 21 CFR Part 11-compliant database and appropriate data standards.

There are also specific public transparency and reporting requirements tied to federal human subjects rules. Funded trials must register on ClinicalTrials.gov before the study begins. They must also post a copy of the informed consent form on a publicly available federal website in accordance with federal requirements described in 32 CFR 219. These requirements are standard for many federally funded trials, but the announcement emphasizes them as non-negotiable elements of the award.

From a funding and award-structure standpoint, the PRORP CTA uses assistance agreements, which can be either grants or cooperative agreements depending on how much substantial involvement the DOD expects to have during performance. If the DOD anticipates no substantial involvement, the award is typically a grant; if substantial involvement is expected (for example, collaboration or participation in the research), it becomes a cooperative agreement, with the specific involvement spelled out in the final award. Budget-wise, the anticipated total costs over the full period of performance are capped at $2.5 million for Research Level 1 and $3.0 million for Research Level 2. For FY23, the program expected to allocate about $10 million total to fund roughly four Research Level 1 awards and about $6 million to fund two Research Level 2 awards, for an estimated six awards overall, contingent on funding availability and the scientific and programmatic review outcomes.

Finally, the administrative facts in the source notice indicate this is a FY23 opportunity managed by the Department of Defense, Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), listed under Assistance Listing (CFDA) 12.420. Eligibility is described as unrestricted (open to any type of entity, subject to any clarifications in the full announcement). The opportunity was posted April 19, 2023, with an original closing date of September 13, 2023, and awards were expected to be made no later than September 30, 2024. The funds for awards made under this FY23 opportunity were anticipated to be FY23 funds available for use through September 30, 2029, which is relevant for understanding the government fiscal lifecycle and how long obligated funds remain available.

• 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 Apr 19, 2023.
• Applicants must submit their applications by Sep 13, 2023. (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 HT9425 23 PRORP CTA

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