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.Apply for HT9425 23 PRORP CTRA
- 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.
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PRORP Clinical Translational Research Award (CTRA) FAQs
1) What is the DoD PRORP Clinical Translational Research Award (CTRA)?
The Department of Defense (DoD) Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Translational Research Award (CTRA) is a funding opportunity intended to accelerate practical, patient-centered advances in diagnosing, treating, rehabilitating, and preventing serious musculoskeletal and orthopaedic injuries. The focus is on research that can improve early outcomes after injury, reduce complications, preserve limbs, and help individuals return to function and work or duty, with clear relevance to Service Members, Veterans, and civilians with similar injuries.
2) What problem is the DoD trying to solve with this award?
The DoD frames the need in terms of readiness and recovery. Extremity battle wounds account for roughly half of the injuries captured in the DoD Trauma Registry, and non-combat orthopaedic injuries (training, sports, wear-and-tear, or prior injuries) also drive lost duty time and reduced readiness. The program aims to fund research that meaningfully improves recovery and functional outcomes for these populations.
3) What types of research does the CTRA support?
CTRA supports clinical translational research that moves promising techniques, tools, or interventions into real-world clinical settings. The goal is to generate strong clinical evidence that can influence near-term clinical decision-making and contribute to future standards of care and evidence-based clinical guidelines.
4) Does my project have to be a clinical trial to qualify?
No. CTRA projects may include a clinical trial, but they do not have to. This is a key distinction from the companion PRORP Clinical Trial Award (CTA), which is limited to clinical trials only.
5) What does the DoD mean by a "clinical trial" in this announcement?
The announcement describes a clinical trial as a study involving prospective assignment of human subjects to interventions to measure biomedical or behavioral outcomes.
6) Are observational or outcomes-focused clinical studies allowed under CTRA?
Yes. The opportunity allows broader clinical research approaches (such as observational, diagnostic, mechanistic, outcomes-focused, epidemiologic, behavioral, or health services-oriented work), as long as the study fits the program intent and does not fall into excluded categories described in the announcement.
7) Are studies with animals allowed?
No. Only clinical research with human subjects, human data, and/or human interaction is supported. Animal research is not allowed under this mechanism.
8) Can a CTRA project include retrospective analysis?
Yes, limited retrospective analysis is permitted when it is part of a broader clinical research plan. However, studies that are purely retrospective or solely based on database mining are not supported.
9) Are pilot clinical trials allowed?
Yes. Small pilot clinical trials are explicitly allowable, aligning with the program goal of building credible clinical evidence that can justify larger trials later.
10) Who should benefit from the research funded by CTRA?
Projects should be clearly connected to the needs of military and/or Veteran populations affected by orthopaedic injury. The DoD also emphasizes broader relevance to civilian patients with similar traumatic or orthopaedic injuries.
11) Do I need to include active-duty Service Members or Veterans as participants?
Including active-duty and/or Veteran participants is encouraged but not mandatory. Regardless, applicants are expected to clearly explain how the work addresses the needs of military and/or Veteran populations.
12) Is collaboration with military or VA clinicians/researchers required?
Collaboration with military or VA clinicians and researchers is encouraged, but the provided information does not state it is mandatory.
13) Is preliminary data required for an application?
Yes. Preliminary data are required. Applicants are expected to provide credible early evidence supporting feasibility and rationale for the proposed clinical study.
14) What does the DoD expect regarding access to patients and enrollment?
Applicants must demonstrate access to an appropriate patient population and provide a realistic accrual (enrollment) plan. The plan should explain how enrollment targets will be met.
15) Are there expectations for including women and minorities in the study?
Yes. The accrual plan should address how women and minorities will be included in a manner consistent with the study objectives.
16) What if the study depends on a drug, device, or other intervention materials?
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.
17) What capabilities does the team need to demonstrate?
The program emphasizes 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.
18) If my project includes a clinical trial, what operational elements are expected?
For studies that include a clinical trial, the DoD expects identification of study coordinator support and clear plans for IRB coordination, participant enrollment operations, and multi-site management if relevant.
19) What are the requirements for the statistical analysis plan?
Applications should include a clearly described statistical analysis plan and a power analysis tied to the study endpoints and sample size.
20) What are the requirements for data management?
Applications should include a data management plan designed to protect the 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.
21) What compliance steps apply to awards that include clinical trials?
Funded clinical trials must be registered on ClinicalTrials.gov before the study begins. In addition, 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).
22) When might an IND or IDE be required?
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.
23) What is the deadline for required FDA regulatory submissions (IND/IDE) after award?
When IND or IDE submissions are necessary, they must be submitted to the FDA within 12 months of the award date. Applicants must also provide evidence from the IRB or FDA if they believe an IND/IDE is not required (or if an abbreviated IDE applies).
24) How do regulatory expectations apply to international study sites?
For international sites, local national regulatory submissions may be required, with similar expectations for submission within the same 12-month window described for IND/IDE-related submissions.
25) What happens if required regulatory submissions are not made on time?
The government reserves the right to withdraw funding if required regulatory submissions are not made within the required timeframe.
26) What type of award instrument will be used (grant vs cooperative agreement)?
Awards are issued as assistance agreements and will be structured as either a grant or a cooperative agreement. If the DoD anticipates substantial involvement during project performance (active collaboration or participation beyond standard oversight), a cooperative agreement may be used; otherwise, a grant is more likely.
27) What is the maximum funding amount per CTRA award (FY23)?
For FY23, the anticipated maximum total cost per award for the entire period of performance is up to $1.5 million.
28) How many awards and how much total funding were expected under this opportunity (FY23)?
Program-wide, the DoD expected to allocate about $6.0 million to fund approximately four CTRA awards, subject to availability of federal funds and the outcomes of scientific and programmatic review.
29) When did this opportunity close?
The opportunity originally closed on September 13, 2023.
30) When were awards expected to be made?
The agency indicated awards would be made no later than September 30, 2024.
31) How long are the FY23 funds available for use?
The announcement noted that FY23 funds remain available for use through September 30, 2029.
32) What is the best fit for a CTRA application?
CTRA is best suited to teams that already have early clinical evidence and a feasible plan to enroll and study 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 decisions and, ultimately, guidelines.
33) What kinds of outcomes does the program emphasize?
The program is oriented toward outcomes that matter for recovery and function, including health, functional capacity, and quality of life after orthopaedic injury, with emphasis on early improvement after injury, reduced complications, and limb preservation.
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