DOD Military Burn - Clinical Translation Research Award | W81XWH 19 MBRP CTRA

Opportunity Information: Apply for W81XWH 19 MBRP CTRA

The DOD Military Burn - Clinical Translation Research Award (CTRA) is a funding opportunity under the Congressionally Directed Medical Research Programs (CDMRP) Military Burn Research Program (MBRP) that is meant to move strong, evidence-based findings into real-world burn care. The central idea is clinical translation: taking promising results from laboratory, preclinical, or earlier clinical work and applying them directly to the treatment of burn-injured patients in ways that can meaningfully change practice. The need is framed in military terms, since burns have historically represented roughly 5 to 20 percent of casualties in conflicts since World War II, and future conflicts or disasters could produce even more burn injuries, especially in rural or austere environments and in mass casualty events where supplies, personnel, and evacuation options are limited.

A major emphasis of the announcement is improving burn care closer to the point of injury, especially in pre-hospital and delayed-evacuation situations. The notice highlights prolonged field care (PFC), defined by NATO as trauma care that extends beyond standard evacuation timelines until the patient can be moved to an appropriate level of care. PFC is described as a priority capability gap across the Army and other services, and applicants are encouraged to design studies whose outcomes help burn casualties when evacuation is delayed for hours, days, or even weeks. That said, the program makes clear that proposals do not have to focus on PFC as long as the work is relevant to active duty service members, veterans, military beneficiaries, and/or the broader American public.

This mechanism is strictly for clinical research involving human subjects; animal studies are not allowed under this award. The types of supported studies can include early proof-of-concept clinical trials, observational studies, work using human anatomical substances, and some retrospective data analysis. Large randomized clinical trials are specifically discouraged, signaling that the program is looking for well-justified, carefully designed clinical translation projects that are feasible within the award size and timeline rather than massive definitive trials. The proposed research must align with one of the FY19/20 CTRA Focus Areas (the announcement notes this requirement even though the focus areas themselves are listed elsewhere in the full program materials).

The funding profile is substantial but targeted. The anticipated total costs for the full period of performance for an individual award are capped at $1.55 million. Program leadership expected to commit about $4.65 million from FY19 funds to support around three awards, with up to an additional $4.65 million from FY20 funds (if appropriated) to support about three more, for an expected total of roughly six awards. Awards were anticipated to be issued no later than September 30, 2021, and funding availability was tied to fiscal year obligation deadlines (FY19 funds by September 30, 2020, and FY20 funds by September 30, 2021). The opportunity was posted March 1, 2019, with an original closing date of July 10, 2019. The listing notes eligibility as unrestricted, meaning any entity type could apply unless otherwise limited by details in the full announcement.

From an award-structure standpoint, recipients should expect either a grant or a cooperative agreement. The deciding factor is how involved the DoD expects to be during performance. If substantial government involvement is anticipated (collaboration, participation, or intervention in aspects of the research), the award is more likely to be a cooperative agreement; if not, it may be a standard grant. The start date and final structure are negotiated, and the award document will spell out any substantial involvement.

The program sets clear expectations for scientific readiness and execution. Preliminary data relevant to the proposed clinical research is required, and the study must be grounded in a sound scientific rationale supported by logical reasoning and a critical review of the literature. Applicants are also expected to demonstrate real access to an appropriate patient population, because the program wants studies that can actually enroll and finish on time with interpretable outcomes. A detailed statistical analysis plan is required, including appropriate statistical expertise on the team and a power analysis that justifies sample size and supports the study objectives. Operationally, the clinical research is expected to start within 12 months of award, or within 18 months for studies regulated by the U.S. Food and Drug Administration (FDA).

Regulatory planning is treated as a serious make-or-break component. If a clinical trial uses a drug that is not FDA-approved for the intended investigational use, an Investigational New Drug (IND) application may be required, and if required it must be submitted to FDA within 12 months of the award date. Similarly, if the investigational product is a device, an Investigational Device Exemption (IDE) may be required; applicants must either document that an IDE is not required (with evidence from the IRB of record or FDA), or submit an IDE to FDA within 12 months if it is required. The opportunity explicitly reserves the right to withdraw funding if an IND or IDE is necessary but is not submitted within that 12-month window. The announcement also points applicants to a specific Regulatory Strategy attachment for documentation expectations.

Human subjects protections add another layer beyond standard academic requirements. All DoD-funded research involving human subjects, human anatomical substances, or human cadavers must be reviewed by the U.S. Army Medical Research and Materiel Command Office of Research Protections, Human Research Protection Office (HRPO) before the research can begin. This HRPO review is in addition to any local Institutional Review Board (IRB) or Ethics Committee review, and applicants are told to plan for at least 2 to 3 months for HRPO review, potentially longer for international studies. Local IRB/EC approval is not required at the time of application submission, but it will be required prior to implementation along with HRPO approval. If the IRB judges a study to be greater than minimal risk, the DoD also requires an independent research monitor with expertise matched to the identified risks, adding oversight expectations that applicants need to budget and plan for. In addition, the program reflects updated federal requirements for clinical trials by noting that funded trials must post the informed consent form on a publicly available federal website in accordance with 32 CFR 219.

For multi-institutional clinical trials, the award expects applicants to present a credible governance and coordination plan. The application should identify the lead organization responsible for the master protocol and master consent form and establish that lead as the single point of contact for regulatory submissions and compliance. A single IRB/EC approach is strongly recommended where feasible. HRPO must review the master protocol and consent form before they are distributed to participating sites for local review, and applications should explain communication processes, data transfer, and how specimens and imaging outputs will be handled. Multi-site projects must also include an intellectual and material property plan agreed to by all participating institutions, reflecting the program’s emphasis on downstream transition and product development.

The program also pushes applicants to think beyond the study itself and toward practical adoption. A Transition Plan is required, describing how the product, approach, or evidence generated will move to the next clinical trial phase and/or toward market delivery after the project ends, including likely funding sources and resources needed. Applicants proposing to enroll human subjects must include quarterly recruitment targets across all sites in the Statement of Work, and awardees will work with USAMRAA to establish formal recruitment milestones; continued support is tied to meeting those milestones, so feasibility of enrollment is a core review and management concern.

Finally, the DoD encourages alignment and collaboration with Department of Defense and Department of Veterans Affairs laboratories, programs, and patient populations. If a project requires access to active duty populations, DoD resources, or DoD databases, the application needs to describe access and include confirmation via letters of support signed by the appropriate approving authority. Similar documentation is expected for VA access: letters of support from VA Facility Directors or designated officials (such as ACOS for Research and Development or a Clinical Service Chief), plus clarity on whether a VA-affiliated nonprofit corporation will administer funds. The program also notes potential future product development partnerships with the U.S. Army Medical Materiel Development Activity, depending on product maturity and military impact, which reinforces that the end goal is usable burn care capabilities, not just publishable results.

• 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 Military Burn - Clinical Translation 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 Mar 01, 2019.
• Applicants must submit their applications by Jul 10, 2019. (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 6 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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