DoD Peer Reviewed Orthopaedic, Clinical Translational Research Award | W81XWH 18 PRORP CTRA

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.

• 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.

Apply for W81XWH 18 PRORP CTRA

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