DoD Neurofibromatosis Clinial Trial Award | Apply Online

Opportunity Summary:

The DoD Neurofibromatosis Clinical Trial Award (NFRP CTA; Funding Opportunity Number W81XWH-14-NFRP-CTA) is a Department of the Army/USAMRAA funding opportunity under the Congressionally Directed Medical Research Programs (CDMRP) designed specifically to accelerate the launch and execution of human clinical trials that could meaningfully improve the treatment or day-to-day management of neurofibromatosis (NF). The program emphasizes speed to clinic and real-world impact, prioritizing trials that can directly inform medical practice, patient outcomes, or the next stage of clinical development. Historically, this mechanism has been used selectively: it was first offered in FY1999, has received 40 applications over time, and 11 have been recommended for funding, which signals that the award is competitive and oriented toward proposals with strong justification and readiness to enroll participants.

This award is explicitly for clinical trials, not preclinical or laboratory-only research. In practical terms, applicants must propose a study that prospectively enrolls human subjects and tests an intervention with measurable outcomes. The announcement defines a clinical trial in a standard way: it involves planned recruitment and enrollment of people, assignment or exposure to an intervention (such as a drug, biologic, medical device, surgical procedure, rehabilitation approach, behavioral intervention, clinical guidance, or another strategy), and systematic measurement of outcomes related to exploratory endpoints, safety, effectiveness, and/or efficacy. The key point is that the measured outcome has to reflect a direct effect of the intervention or interaction on the human participant. If a project is primarily aimed at generating preclinical data, validating animal models, or doing bench work to justify future testing, it does not fit this mechanism and should be redirected to other NFRP award types.

In terms of what can be tested, the NFRP CTA is broad and practical. It supports clinical trials that evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance approaches, and emerging technologies or methods that could improve care. The award is structured to accommodate a wide range of trial maturity levels, from early, smaller proof-of-concept efforts to larger trials intended to determine efficacy in the relevant patient population. The opportunity specifically mentions that projects may range from pilot, first-in-human, or Phase 0 studies that establish feasibility or refine the design of later trials, all the way through large-scale studies focused on demonstrating efficacy.

Readiness requirements depend on the trial stage. For pilot trials, the application must include scientific rationale and/or preliminary data relevant to the proposed pilot clinical trial, meaning the proposer must explain why the intervention is plausible and provide supporting evidence appropriate to an early-stage human study. For Phase I and Phase II trials, the bar is higher: both scientific rationale and preliminary data relevant to the proposed clinical trial are required, reflecting the expectation that Phase I/II studies should be grounded in prior evidence and a clearer development path. Overall, the mechanism is geared toward studies that are ready to move forward, with enough justification to support human enrollment and meaningful outcome assessment.

Administratively, this opportunity was posted May 27, 2014 (created May 28, 2014) with an original and current closing date of July 24, 2014, and an archive date of August 23, 2014. It is categorized as a discretionary funding opportunity and uses Cooperative Agreement and Grant funding instruments within the Science and Technology/Research and Development activity category. The estimated total funding listed is $2,880,000, with an expected number of awards of 2, suggesting relatively large individual award sizes and a competitive selection environment. The CFDA number associated with this program is 12.420 (Military Medical Research and Development). Cost sharing or matching is not required, which reduces financial barriers for applicants and allows budgeting to focus on executing the clinical trial itself.

Eligibility is described as unrestricted, meaning it is open to any type of entity as long as it meets any clarifications included in the full announcement’s eligibility section. The announcement also points applicants to human subjects resources hosted through eBRAP, including a Human Subject Resource Document, reinforcing that compliance, protections for participants, and proper trial oversight are central expectations for applicants. For help accessing the full announcement or navigating the submission system, the CDMRP Help Desk can be reached at 301-682-5507 or help@eBRAP.org.

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