DOD Peer Reviewed Orthopaedic, Clinical Translational Research Award | HT9425 23 PRORP CTRA

Opportunity Information: Apply for HT9425 23 PRORP CTRA

The Department of Defense (DoD) Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Translational Research Award (CTRA) is a funding opportunity designed to speed up practical, patient-centered advances in the diagnosis, treatment, rehabilitation, and prevention of serious musculoskeletal and orthopaedic injuries. The DoD frames this need in terms of military readiness and recovery: extremity battle wounds make up roughly half of the injuries captured in the DoD Trauma Registry, and non-combat orthopaedic injuries (from training, sports, wear-and-tear, or prior injuries) are also a major driver of lost duty time and reduced readiness. The program emphasis is on research that can improve outcomes early after injury, reduce complications, preserve limbs, and ultimately help people return to function and work or duty, with relevance to Service Members, Veterans, and civilian patients with similar injuries.

The CTRA specifically targets high-impact clinical research that is promising but not necessarily mature enough for a large, definitive randomized controlled trial. In other words, it is meant for clinical translational work that can move emerging techniques, tools, or interventions into real-world clinical settings, generate strong evidence, and shape future standards of care and evidence-based clinical guidelines. A key distinction in this announcement is that CTRA projects may include a clinical trial but do not have to; in contrast, the companion PRORP Clinical Trial Award (CTA) mechanism is limited to clinical trials only. The intent is to fund studies that can meaningfully inform near-term clinical decision-making and longer-term practice changes, even if the work is at the pilot or early validation stage.

Only clinical research with human subjects, human data, and/or human interaction is supported under this mechanism; animal research is not allowed. The opportunity permits interventional studies and allows limited retrospective analysis as part of a broader clinical research plan, but it does not support studies that are purely retrospective or solely based on database mining. Small pilot clinical trials are explicitly allowable, which fits the program goal of building credible clinical evidence that can justify larger trials later. Applicants are expected to clearly connect their proposed work to the needs of military and/or Veteran populations affected by orthopaedic injury. Including active-duty and/or Veteran participants is encouraged but not mandatory, and collaboration with military or VA clinicians and researchers is also encouraged.

Several application expectations are emphasized as core requirements. Preliminary data are required, meaning teams must show credible early evidence that supports feasibility and rationale for the proposed clinical study. Applicants must also demonstrate access to an appropriate patient population and provide a realistic accrual plan, including how enrollment targets will be met and how women and minorities will be included in a manner consistent with the study objectives. If the project depends on a drug, device, or other intervention materials, the application must document availability and access to those resources for the full study period. The program also places weight on team capability and infrastructure: the research group should show experience running clinical research, handling statistics and data management, and navigating FDA-related requirements when applicable. For studies that include a clinical trial, identifying study coordinator support is expected, along with clear plans for IRB coordination, multi-site management (if relevant), and participant enrollment operations.

Strong statistical and data management planning is a prominent requirement. Applications should include a clearly described statistical analysis plan and power analysis tied to the study endpoints and sample size, along with a data management plan that protects integrity and security of the dataset. If the work is FDA-regulated, the study must use a database compliant with 21 CFR Part 11 and follow appropriate data standards. The announcement also clarifies how it defines a clinical trial (prospective assignment of human subjects to interventions to measure biomedical or behavioral outcomes) versus broader clinical research that may be observational, diagnostic, mechanistic, outcomes-focused, epidemiologic, behavioral, or health services-oriented, as long as it does not fall into excluded categories such as certain exempt secondary research.

For awards that include clinical trials, the DoD highlights compliance obligations that applicants should be ready to handle. Funded clinical trials must be registered on ClinicalTrials.gov before the study begins, and a copy of the informed consent form used for enrollment must be posted on a publicly available federal website in line with federal requirements (referencing 32 CFR 219). If the study involves an unapproved drug use, an Investigational New Drug (IND) application may be required; if an investigational device is used, an Investigational Device Exemption (IDE) may be required. When IND or IDE submissions are necessary, they must be submitted to the FDA within 12 months of the award date, and applicants must provide evidence from the IRB or FDA if they believe an IND/IDE is not required (or if an abbreviated IDE applies). Similar expectations apply to international sites, where local national regulatory submissions may be required within the same 12-month window. The government reserves the right to withdraw funding if required regulatory submissions are not made on time.

From a funding and administrative standpoint, awards are issued as assistance agreements, meaning they will be structured as either a grant or a cooperative agreement depending on how much substantial involvement the DoD expects to have during project performance. If the DoD anticipates active collaboration or participation (beyond standard oversight), a cooperative agreement may be used; otherwise, a grant is more likely. For FY23, the anticipated maximum total cost per award for the entire period of performance is up to $1.5 million. Program-wide, the DoD expected to allocate about $6.0 million to fund approximately four CTRA awards, with final selections dependent on federal fund availability and on scientific and programmatic review outcomes. The opportunity originally closed on September 13, 2023, and the agency indicated awards would be made no later than September 30, 2024, using FY23 funds that remain available for use through September 30, 2029.

In practical terms, the PRORP CTRA is best viewed as a mechanism for teams that already have early clinical evidence and a feasible path to enrolling and studying real patients, and who want to translate an intervention, diagnostic approach, rehabilitation strategy, or prevention method into the clinic with enough rigor to influence care guidelines. The program is explicitly oriented toward outcomes that matter for recovery and function, including health, functional capacity, and quality of life after orthopaedic injury, with an emphasis on relevance to the military and Veteran community while still aiming for broader impact across civilian trauma and orthopaedic care.

• 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 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 4 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 CTRA

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