DoD Peer Reviewed Orthopaedic, Clinical Trial Award | HT942524PRORPCTA

Opportunity Information: Apply for HT942524PRORPCTA

The DoD Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award (CTA) is a Department of Defense grant opportunity aimed at quickly launching human clinical trials that could meaningfully improve how serious orthopaedic injuries are treated and managed, especially injuries tied to military service and combat that affect readiness and return-to-duty or return-to-work outcomes. The program is motivated by the scale of the problem: extremity injuries account for roughly half of the cases captured in the DoD Trauma Registry, and non-combat orthopaedic injuries (from training, sports, wear-and-tear, or prior injuries) remain a major driver of lost readiness across the force. A central theme is speed and proximity of care, meaning applicants are encouraged to show how their trial could support treatment closer to the point of injury and/or shorten the timeline for functional recovery and return to duty.

This mechanism is strictly for clinical trials in human subjects and does not fund animal studies or other preclinical work. The opportunity uses the federal definition of a clinical trial (45 CFR 46.102): a study where one or more human subjects are prospectively assigned to an intervention (including placebo or control) to evaluate effects on biomedical or behavioral health-related outcomes. In practical terms, the CTA is meant for studies that measure safety, effectiveness, and/or efficacy of an intervention; projects that do not evaluate those kinds of outcomes are not considered clinical trials under this announcement. The CTA can support a wide range of trial stages, from smaller proof-of-concept efforts (including pilot, first-in-human, or phase 0 style trials intended to establish feasibility or inform later designs) to larger trials designed to determine efficacy in relevant patient populations. Trials can test products and approaches such as drugs or biologics, medical devices, clinical guidance, and emerging technologies.

Even though the PRORP is military-focused, the program makes it clear that funded research should also be relevant to civilians who experience major orthopaedic injury. The announcement also notes a boundary around arthritis: because an Arthritis Research Program has started, FY24 PRORP may not fund arthritis research itself. However, studies addressing conditions or health abnormalities related to arthritis can still be permissible as long as the work clearly aligns with the selected PRORP Focus Area.

A key structural point is how this CTA differs from the PRORP Clinical Translational Research Award (CTRA). The CTRA can support clinical research that may or may not include a clinical trial, while the CTA is limited to clinical trials only. All applications to this CTA are eligible for Research Level 1. In addition, certain applications under the Focus Area "Translation of Early Findings - Soft Tissue Trauma" can apply for a Collaborative Care Option designated as Research Level 2. That Research Level 2 option is intended to push true interdisciplinary collaboration between surgical and rehabilitation disciplines, such as surgeons working alongside physical therapists, occupational therapists, prosthetists, and other orthopaedic care providers. The expectation is that the project is cohesive and integrated, combining surgical strategies (for example, reconstruction/repair or the use of biologics, pharmaceuticals, or devices to restore tissue structure and function) with rehabilitative strategies (approaches that restore function and independence after injury). Applicants must spell out the rehabilitation strategy and the standard of care, and studies that track patients across the continuum of care are explicitly encouraged. To ensure the collaboration is real and operational, the application must include at least one investigator with orthopaedic rehabilitation expertise and at least one clinician specializing in orthopaedic or trauma care, plus Letters of Collaboration from each specialist serving as Key Personnel (excluding the PI). The program defines a clinician as someone credentialed and actively practicing in a relevant care role.

The CTA emphasizes readiness to execute. Trials are expected to start quickly: no later than 6 months after the award date in general, or up to 12 months after the award date when the study is regulated by a Regulatory Agency (for example, the FDA or an applicable international regulator). Preliminary data are required, meaning applicants need to show existing evidence that supports the proposed intervention and trial design. The application must also demonstrate access to an appropriate study population and provide a realistic accrual plan, including a strategy for inclusion of women and minorities that fits the study objectives. An exception is noted for certain exempt research using biospecimens or datasets that cannot be linked back to an individual or to demographic identifiers like sex, ethnicity, or race. In addition, applicants must show documented availability and access to the intervention itself (drug, device, compound, or other materials) for the full proposed study period.

Operational capability is another major review concern. The application is expected to show that the team and environment are genuinely prepared to run a compliant clinical trial, including expertise in trial conduct, statistical analysis, data management, and FDA processes when relevant. The program expects applicants to include study coordinator support to navigate IRB review and other regulatory steps, coordinate multi-site activities, and manage participant recruitment. Where applicable, the institution should demonstrate strong backing and a willingness to serve as the FDA regulatory sponsor, carrying out sponsor responsibilities described in 21 CFR 312, Subpart D. On the analytics side, the proposal must include a clear statistical analysis plan, a power analysis tied to sample size and study objectives, and a data management plan that protects integrity and security of study data. If a Regulatory Agency requires it, the trial must use a 21 CFR Part 11-compliant database and appropriate data standards.

Regulatory timelines are treated as firm deliverables. If a proposed trial needs an Investigational New Drug (IND) application (or equivalent) under 21 CFR 312, or an Investigational Device Exemption (IDE) application (or equivalent) under 21 CFR 812, the applicant is responsible for either providing evidence that it is not required or submitting the required regulatory application within 6 months of the CTA award start date. The same 6-month expectation applies to relevant international regulatory applications for investigational products tested at international sites. The government explicitly reserves the right to withdraw funding if required IND/IDE or international regulatory submissions are not made within that 6-month window. The opportunity also points applicants to the CDMRP Human Subjects Resource Document (December 2022) for additional guidance.

The funding instrument is a grant under 31 USC 6304, with total costs (for the entire period of performance) capped at $2.5 million for Research Level 1 and $3.25 million for Research Level 2. The program anticipates about $13.25 million total to support roughly four Research Level 1 awards and one Research Level 2 award, with final selections dependent on federal fund availability and peer and programmatic review outcomes. The administering agency is the Department of the Army, USAMRAA, under CFDA 12.420, with eligibility listed as unrestricted. The opportunity number is HT942524PRORPCTA, and the original application closing date was September 17, 2024. Awards supported with FY24 funds are expected to be made no later than September 30, 2025, and those FY24 funds are anticipated to remain available for use until they expire on September 30, 2030.

• 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 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 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.

Apply for HT942524PRORPCTA

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