DoD Peer Reviewed Orthopaedic, Clinical Trial Award | W81XWH 18 PRORP CTA

Opportunity Information: Apply for W81XWH 18 PRORP CTA

The Department of Defense (DoD) Peer Reviewed Orthopaedic, Clinical Trial Award (PRORP CTA; Funding Opportunity Number W81XWH-18-PRORP-CTA) is a FY2018 funding opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) to push clinically ready orthopaedic interventions into human testing as quickly as possible. The core purpose is practical impact: it is meant to fund clinical trials that could materially improve outcomes for military service members and Veterans with combat-related orthopaedic injuries, as well as non-battle orthopaedic injuries that still meaningfully affect unit readiness and the ability to return to duty or work. A major theme throughout the announcement is operational relevance, meaning applicants are expected to connect their proposed trial to real-world military needs, including approaches that help deliver care closer to the point of injury and/or shorten recovery time so patients can return to duty/work sooner.

This mechanism is strictly for clinical trials, not general clinical research and not preclinical development. The announcement explicitly contrasts this award with the PRORP Clinical Translational Research Award (CTRA): the CTRA can support broader clinical research activities, but the CTA is limited to clinical trials only, and CTA funds cannot be used for preclinical studies. The program allows a wide range of trial sizes and maturity levels, from small proof-of-concept efforts (including pilot studies, first-in-human work, or Phase 0 designs intended to test feasibility or generate data to design a larger trial) all the way up to large trials designed to determine efficacy in the appropriate patient populations. What makes a project fit this mechanism is not the size of the trial, but the fact that it prospectively enrolls human participants and tests an intervention with measurable outcomes tied to safety, effectiveness, and/or efficacy.

The opportunity uses a straightforward definition of a clinical trial: a prospective accrual of human subjects in which an intervention is tested and the outcomes reflect a direct effect of that intervention on the participant. The announcement gives broad examples of what counts as an intervention, including devices, drugs, biologics, surgical procedures, rehabilitation approaches, behavioral interventions, or other modalities. Applicants are also pointed to a Human Subject Resource Document hosted on eBRAP for additional guidance on human subjects considerations, reinforcing that this mechanism is built around regulated, participant-based clinical testing rather than observational or laboratory work.

There are also clear regulatory expectations for trials that involve investigational products. If the study uses a drug that is not FDA-approved for the proposed investigational use, an Investigational New Drug (IND) application under 21 CFR 312 may be required, and if so it must be submitted to FDA within 6 months of the award date. If the investigational product is a device, the program requires evidence that an Investigational Device Exemption (IDE) application meeting 21 CFR 812 has been submitted within 6 months of the award date, unless the device is exempt or qualifies for an abbreviated IDE. The DoD emphasizes follow-through by reserving the right to withdraw funding if an IND/IDE is required but not submitted within 6 months, or if documented IND/IDE status has not been obtained within 12 months of the award date. In practice, this means applicants need to think carefully about regulatory pathways and timelines during proposal development, not after an award is made.

Several scope limitations matter for fit. Animal research is not allowed under this CTA, underscoring again that this is not a preclinical mechanism. Investigators who want support for preclinical orthopaedic research are directed instead to the PRORP Applied Research Award (ARA) mechanism. Another notable limitation is that sports injury research generally does not meet the intent of the program and will not be funded unless the sports injury topic is directly related to a combat injury, which keeps the portfolio focused on military-relevant trauma and readiness rather than civilian athletics.

In terms of who can apply and what kinds of projects are favored, eligibility is described as unrestricted (open to any entity type, subject to any clarifications in the full announcement). However, every application must clearly articulate relevance to military and/or Veteran populations affected by orthopaedic injury. The program encourages collaboration with military and Department of Veterans Affairs (VA) researchers and clinicians, and it also encourages studies that include active duty service members or Veterans as all or part of the study population. Administratively, the opportunity is listed as discretionary and supports awards through grants and cooperative agreements under CFDA 12.420. The posting indicates an expected four awards, was created June 18, 2018, and had an original closing date of October 24, 2018 (with no specified award ceiling listed in the excerpt provided).

• 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 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 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 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 W81XWH 18 PRORP CTA

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