DoD Neurofibromatosis Clinical Trial Award | HT9425 23 NFRP CTA

Opportunity Information: Apply for HT9425 23 NFRP CTA

The Department of Defense Neurofibromatosis Research Program (NFRP) Clinical Trial Award is a funding opportunity designed to move neurofibromatosis (NF) research quickly into the clinic by supporting the rapid start-up and execution of clinical trials that could meaningfully change how NF is treated or managed. The award is aimed at trials with clear potential for patient impact, whether that means testing a new therapy, improving how symptoms are managed, validating better ways to measure disease, or bringing an emerging technology into real-world clinical use. The program frames its overall goal for FY23 as decreasing the clinical impact of NF, meaning it is oriented toward practical outcomes that improve health, function, and quality of life for people living with NF1, NF2, and Schwannomatosis.

Projects supported under this award can cover a wide range of trial stages and sizes. Applicants can propose early, smaller proof-of-concept studies such as pilot trials, first-in-human efforts, or phase 0 work intended to show feasibility, refine dosing or procedures, or generate the data needed to justify a larger trial. On the other end of the spectrum, proposals may also involve larger-scale trials designed to determine efficacy in the relevant patient population. The opportunity is flexible on what is being evaluated: trials may test pharmacologic agents including drugs and biologics, devices, clinical guidance or care approaches, and other emerging methods or technologies that could improve outcomes for NF patients.

A major theme of the award is pushing the field forward through innovation, collaboration, and translation. The NFRP emphasizes high-impact research that opens new directions and addresses issues that have been underexplored or neglected in NF. It also explicitly encourages multidisciplinary and multi-institutional collaborations, signaling that proposals bringing together different specialties (for example, neurology, oncology, otology, imaging, genetics, pain medicine, rehabilitation, data science) and multiple clinical sites may be particularly well aligned. Another central priority is translational and clinical work that moves promising ideas from bench to bedside, supporting a balanced portfolio across NF1, NF2, and Schwannomatosis rather than focusing narrowly on a single slice of the disease landscape.

For FY23, the program highlights several Areas of Emphasis that reflect urgent needs in the NF community. One area focuses on NF2 and Schwannomatosis-related problems, including hearing and balance issues, schwannomas, and associated tumor types such as ependymomas and meningiomas, as well as genetic drivers and subtypes involving LZTR1 and SMARCB1. Another area prioritizes endpoint validation and biomarker discovery along with technological innovation for assessments, which is essentially about improving the tools used to measure whether a treatment is working, how the disease is changing, and how patients are functioning. The program also encourages the application of data science, which can include advanced analytics, integration of clinical and real-world data, computational approaches to improve trial design, or methods that sharpen prediction and decision-making. In addition, it calls attention to non-tumor manifestations, explicitly naming pain, cognitive manifestations, and sleep, reinforcing that NF burden is not limited to tumor growth and that symptom-focused trials are responsive to real patient needs. Across these emphasis areas, applications are encouraged to include materials and data from diverse populations, reflecting an expectation that trial evidence should be relevant and equitable across different patient groups.

Administratively, this opportunity is offered by the Department of Defense, Department of the Army, through the US Army Medical Research Acquisition Activity (USAMRAA). It is listed as a discretionary funding opportunity under CFDA 12.420 and uses grant and cooperative agreement mechanisms, meaning some awards may include more active involvement or coordination by the funder depending on the specific agreement structure. Eligibility is described as unrestricted (open to any type of entity), subject to any additional limits that may be described in the full announcement. The opportunity number is HT9425-23-NFRP-CTA. The posting date was May 22, 2023, with an original closing date of August 25, 2023. The notice lists an expected number of awards of 1, and the award ceiling is shown as 0, which typically indicates the ceiling is not specified in the summary and would need to be confirmed in the full funding announcement or associated program documents.

Overall, the DoD NFRP Clinical Trial Award is best understood as a patient-impact-driven clinical trials mechanism: it is built to accelerate NF trials that can change care, encourages cross-institution teamwork, and strongly prioritizes measurable, clinically meaningful outcomes, especially in NF2 and Schwannomatosis challenges, better endpoints and biomarkers, data science-enabled approaches, and non-tumor symptoms like pain, cognition, and sleep.

• 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 Neurofibromatosis 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 May 22, 2023.
• Applicants must submit their applications by Aug 25, 2023. (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 1 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 HT9425 23 NFRP CTA

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