Opportunity Information: Apply for W81XWH 18 PRORP CTRA
The DoD Peer Reviewed Orthopaedic, Clinical Translational Research Award (CTRA) is a FY18 funding opportunity from the Department of Defense (U.S. Army Medical Research Acquisition Activity, under CFDA 12.420) that supports clinical translational research aimed at improving care for military personnel and Veterans with orthopaedic injuries. The program is designed for projects that are high-impact and/or involve new or emerging clinical approaches, including work that may not yet be ready to launch as a large, full-scale randomized controlled trial. Across the entire period of performance, the total costs for a single award are capped at $2 million, and the agency anticipated making about five awards under this mechanism.
The core emphasis is on studies with clear potential to change or inform the standard of care in both the near term and the longer term, while also strengthening the evidence base that feeds into clinical guidelines for evaluating and treating orthopaedic injuries in military and Veteran populations. A major translational goal is to move promising techniques and interventions into practical clinical use, including settings closer to the point of injury and within the Prolonged Field Care (PFC) environment. Applicants are expected to think beyond narrow clinical endpoints and address outcomes that matter to patients living with orthopaedic injuries, such as health status, functional performance, and overall quality of life. Another stated goal is comparative and decision-relevant evidence: the program wants research that helps identify the most effective options for diagnosis, treatment, rehabilitation, and prevention so that patients, clinicians, caregivers, and policymakers can make better-informed decisions.
To fit the award’s intent, each application must directly address one primary FY18 PRORP CTRA Focus Area (as defined in the full announcement). The program also draws a clear boundary around sports injury studies: proposals centered on sports injuries are not considered responsive unless the sports injury is explicitly related to a combat injury. In other words, the work needs to be grounded in the needs and realities of military service-related orthopaedic trauma rather than general athletics-focused questions.
Structurally, the CTRA differs from the companion FY18 PRORP Clinical Trial Award (CTA). The CTA is limited to clinical trials only, while the CTRA is broader and can support clinical research projects that may include, but are not limited to, clinical trials. Even with that flexibility, the CTRA still requires human subjects involvement. Studies may be interventional and may include some retrospective data analysis, but purely retrospective or database-only studies are not allowed. The mechanism also permits small pilot clinical trials. The announcement uses a standard definition of a clinical trial: prospective enrollment of human subjects where an intervention (such as a device, drug, biologic, surgery, rehabilitation method, behavioral intervention, or similar) is tested and evaluated using measurable outcomes related to safety, effectiveness, and/or efficacy.
There are also important regulatory expectations tied to FDA oversight when investigational products are involved. If a proposed trial uses a drug that is not FDA-approved for the intended investigational use, an Investigational New Drug (IND) application that complies with 21 CFR 312 may be required, and it must be submitted to the FDA within six months of the award date. Similarly, if the investigational product is a medical device, the award requires evidence that an Investigational Device Exemption (IDE) submission meeting 21 CFR 812 has been filed within six months of the award date, unless the device is exempt or qualifies for an abbreviated IDE. The government explicitly reserves the right to withdraw funding if an IND or IDE is required but is not submitted within that six-month window, making early regulatory planning and realistic timelines a key part of a competitive and viable proposal.
The CTRA specifically excludes animal research. Studies that involve animals, including animal work intended to develop or refine technology or establish efficacy or effectiveness of diagnostic agents, are not allowable under this funding opportunity. Investigators with animal-based concepts are directed instead to other PRORP mechanisms (such as the Applied Research Award) that are better aligned with preclinical research.
Finally, military relevance is not optional. Every application must clearly explain how the project is relevant to military and/or Veteran populations affected by orthopaedic injury. While not strictly required, the program encourages studies that include active duty service members and/or Veterans as part of the participant population, and it also encourages collaboration with military and Department of Veterans Affairs researchers or clinicians. The overall theme is practical clinical translation: human-subjects research that produces actionable evidence and moves promising interventions toward real-world use in the settings and conditions that matter most for service-related orthopaedic injury care.Apply for W81XWH 18 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 Jun 18, 2018.
- Applicants must submit their applications by Oct 24, 2018. (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 5 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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FAQs: DoD Peer Reviewed Orthopaedic, Clinical Translational Research Award (CTRA) (FY18)
What is the FY18 DoD Peer Reviewed Orthopaedic, Clinical Translational Research Award (CTRA)?
The CTRA is a Department of Defense (DoD) funding opportunity under the Peer Reviewed Orthopaedic Research Program (PRORP) that supports clinical translational research intended to improve care for military personnel and Veterans with orthopaedic injuries. It is managed through the U.S. Army Medical Research Acquisition Activity (CFDA 12.420).
What kind of research is this award designed to support?
The CTRA supports high-impact clinical translational research, including new or emerging clinical approaches. It is specifically suited to projects that aim to move promising techniques and interventions into practical clinical use, including work that may not yet be ready to launch as a large, full-scale randomized controlled trial.
What is the main goal or emphasis of the CTRA program?
The core emphasis is on studies with clear potential to change or inform the standard of care in both the near term and the longer term. The program also aims to strengthen the evidence base that informs clinical guidelines for evaluating and treating orthopaedic injuries in military and Veteran populations.
How much funding is available per award?
Total costs for a single award are capped at $2 million across the entire period of performance.
How many awards did the agency expect to make under this mechanism?
The agency anticipated making about five awards under the CTRA mechanism.
Does the CTRA require human subjects?
Yes. Human subjects involvement is required under the CTRA.
Are clinical trials allowed under the CTRA?
Yes. The CTRA can support clinical research projects that may include, but are not limited to, clinical trials. It also permits small pilot clinical trials.
How does the CTRA differ from the FY18 PRORP Clinical Trial Award (CTA)?
The CTA is limited to clinical trials only. The CTRA is broader and can support clinical research that may include clinical trials, but is not restricted exclusively to clinical trials.
What definition of "clinical trial" applies to this opportunity?
The announcement uses a standard definition: a clinical trial involves prospective enrollment of human subjects where an intervention is tested and evaluated using measurable outcomes related to safety, effectiveness, and/or efficacy. Interventions can include devices, drugs, biologics, surgery, rehabilitation methods, behavioral interventions, or similar approaches.
Can the study include retrospective data analysis?
Some retrospective data analysis may be included, but purely retrospective or database-only studies are not allowed under this mechanism.
Are database-only studies eligible?
No. Purely retrospective or database-only studies are not permitted.
Are interventional studies allowed?
Yes. Studies may be interventional, and the program specifically contemplates testing interventions with measurable outcomes.
Do applications need to align with specific program priorities or focus areas?
Yes. Each application must directly address one primary FY18 PRORP CTRA Focus Area (as defined in the full announcement).
Are sports injury studies allowed?
Sports injury proposals are not considered responsive unless the sports injury is explicitly related to a combat injury. The intent is to keep the research grounded in military service-related orthopaedic trauma rather than general athletics-focused questions.
What kinds of outcomes does the program want applicants to measure?
Applicants are expected to look beyond narrow clinical endpoints and address outcomes that matter to patients living with orthopaedic injuries. Examples stated in the opportunity include health status, functional performance, and overall quality of life.
Does the CTRA prioritize research that helps with real-world clinical decision-making?
Yes. A stated goal is generating comparative and decision-relevant evidence that helps identify the most effective options for diagnosis, treatment, rehabilitation, and prevention so that patients, clinicians, caregivers, and policymakers can make better-informed decisions.
What does "clinical translational" mean in the context of this award?
In this context, it refers to moving promising techniques and interventions into practical clinical use, including in settings closer to the point of injury and within the Prolonged Field Care (PFC) environment.
Is research aimed at Prolonged Field Care (PFC) settings relevant to this award?
Yes. The opportunity explicitly highlights translation into practical use in environments closer to the point of injury, including within the Prolonged Field Care (PFC) setting.
Is animal research allowed under the CTRA?
No. Animal research is specifically excluded. Studies involving animals, including animal work aimed at developing or refining technology or establishing efficacy or effectiveness of diagnostic agents, are not allowable under this funding opportunity.
If a project includes animal work as one component, can it still be funded?
No. The opportunity states that studies that involve animals are not allowable under this mechanism.
What should investigators do if their concept is primarily animal-based or preclinical?
The announcement indicates that investigators with animal-based concepts should look to other PRORP mechanisms (for example, the Applied Research Award) that are better aligned with preclinical research.
What regulatory requirements apply if the study uses an investigational drug?
If a proposed trial uses a drug that is not FDA-approved for the intended investigational use, an Investigational New Drug (IND) application that complies with 21 CFR 312 may be required. If required, it must be submitted to the FDA within six months of the award date.
What regulatory requirements apply if the study uses an investigational medical device?
If the investigational product is a medical device, the award requires evidence that an Investigational Device Exemption (IDE) submission meeting 21 CFR 812 has been filed within six months of the award date, unless the device is exempt or qualifies for an abbreviated IDE.
What is the deadline for submitting an IND or IDE after award?
If an IND or IDE is required, it must be submitted (or evidence of required IDE submission must be provided, as described) within six months of the award date.
What happens if an IND or IDE is required but not submitted within six months?
The government explicitly reserves the right to withdraw funding if an IND or IDE is required but is not submitted within the six-month window.
Does the program allow FDA-exempt or abbreviated IDE pathways for devices?
Yes. The IDE requirement is framed to apply unless the device is exempt or qualifies for an abbreviated IDE.
Why is early regulatory planning important for CTRA applications?
Because the opportunity ties continued funding to timely IND/IDE submissions when required, early regulatory planning and realistic timelines are described as key to a competitive and viable proposal.
Is military relevance required?
Yes. Military relevance is not optional. Every application must clearly explain how the project is relevant to military and/or Veteran populations affected by orthopaedic injury.
Does the program require enrollment of active duty service members or Veterans?
It is not strictly required, but the program encourages studies that include active duty service members and/or Veterans as participants.
Are collaborations with military or VA partners encouraged?
Yes. Collaboration with military and Department of Veterans Affairs (VA) researchers or clinicians is encouraged.
What types of orthopaedic injury topics does the CTRA want to address?
Based on the information provided, the intent is orthopaedic injury care relevant to military and Veteran populations, with an emphasis on actionable evidence for diagnosis, treatment, rehabilitation, and prevention and on translation into real-world clinical practice (including point-of-injury and PFC-relevant settings).
Is the CTRA intended only for large randomized controlled trials?
No. The program explicitly supports work that may not yet be ready for a large, full-scale randomized controlled trial and allows small pilot clinical trials, while still emphasizing impact and translation.
What is the overall theme of the CTRA mechanism?
Practical clinical translation through human-subjects research that produces actionable evidence and moves promising interventions toward real-world use for service-related orthopaedic injury care.
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