DoD Neurofibromatosis Clinical Trial Award | Apply Online

Opportunity Summary:

The DoD Neurofibromatosis Research Program (NFRP) Clinical Trial Award is a Department of Defense funding opportunity meant to push forward clinical research that could noticeably improve how neurofibromatosis (NF) is treated or managed. The program is focused on human clinical trials that test interventions with real potential to change patient care, including drugs and biologics, medical devices, surgical or rehabilitative approaches, behavioral interventions, clinical guidance, and other emerging technologies. The scope is broad enough to support anything from early, small proof-of-concept work (such as pilot studies, first-in-human efforts, or Phase 0 trials) that establish feasibility or help shape later trials, all the way to larger trials designed to determine efficacy in the relevant NF patient populations. The key theme is impact: the trial should be positioned to meaningfully move the field toward better therapies, better management strategies, or clearer clinical decision-making.

A central requirement is that the award must fund an actual clinical trial, not preclinical or animal/lab-only research. In this announcement, a clinical trial is defined in the standard federal way: a prospective study that accrues human participants and tests an intervention in people to measure outcomes tied to safety, effectiveness, efficacy, or exploratory clinical information. In other words, the measurable outcome must reflect a direct effect of the intervention or interaction on the human subject. Applicants who only have preclinical aims are directed to pursue other NFRP award mechanisms instead. The opportunity also highlights that "human subjects" refers to the individuals recruited for and participating in the proposed trial, and it points applicants to an online human subject resource document housed on eBRAP for additional guidance.

Because many NF studies involve investigational therapies, the award places heavy emphasis on regulatory readiness. If the trial uses a drug that is not FDA-approved for the proposed investigational use, the application must include evidence that an Investigational New Drug (IND) submission that meets 21 CFR 312 requirements has been filed with the FDA before the application deadline, or documentation that the study is IND-exempt. Likewise, if the product is a device, the applicant must show that an Investigational Device Exemption (IDE) submission meeting 21 CFR 812 requirements has been filed prior to the deadline, or that the device is IDE-exempt. Applicants must include the NFRP IND/IDE Documentation Form, and they must obtain and submit proof of IND/IDE approval to the CDMRP Help Desk before programmatic review; otherwise, the government may withdraw the application from consideration. This effectively means applicants need to be far enough along that the regulatory pathway is not hypothetical, and the timeline risk is minimized.

The submission expectations are detailed and reflect what the DoD wants to see from a trial that is ready to launch. The trial is expected to start within six months of the award date, and that six-month window includes the time needed for IRB and other regulatory approvals, so the proposal needs to demonstrate practical start-up feasibility. The application must include a solid statistical analysis plan aligned with the trial phase, along with a power analysis and sample size projections that match the study objectives, plus evidence of appropriate statistical expertise on the team. It also must show that the intervention can actually be delivered: applicants need documented availability and access to the drug/compound, device, or other materials, such as a letter from the manufacturer confirming adequate supply (and placebo if applicable). In parallel, the proposal has to show access to a suitable patient population and present a credible accrual and retention plan, including discussion of how enrollment targets will be met and maintained and how standards of care might influence recruitment or outcomes.

Operational and quality expectations are similarly strong. Proposals should include a study coordinator (as appropriate for the trial) to shepherd the protocol through the local IRB of record and other approvals, coordinate activities across all sites, and manage participant accrual. The trial design is expected to have clearly defined endpoints and to follow Good Clinical Practice (GCP). Applicants are also expected to spell out a clinical monitoring plan for GCP compliance, a data management plan that uses an appropriate database to protect data quality and integrity, and a safety management plan describing how pharmacovigilance and safety reporting will be handled when relevant. In addition, the application must acknowledge a commitment to register the study on ClinicalTrials.gov, reinforcing transparency and public reporting norms for clinical trials.

The award also asks applicants to look beyond the immediate study and explain what happens next. Applications should include a transition plan describing how, if the trial is successful, the product or approach will advance to the next clinical trial phase and/or move toward market delivery, including likely resources and funding pathways. The proposal must also demonstrate strong institutional support and commitment, signaling that the host organization will provide the infrastructure and backing needed to run a compliant, well-managed trial.

For multi-institutional clinical trials, the announcement adds extra coordination and governance requirements. Applicants need to describe how collaborating sites will communicate and transfer data, and how biospecimens and/or imaging outputs collected during the study will be handled. Multi-site proposals must also include a separate intellectual and material property plan that all participating institutions agree to, reflecting the added complexity of ownership, sharing, and downstream commercialization or dissemination when more than one organization is involved.

Administrative details in the source listing indicate this was a discretionary DoD opportunity administered through DOD-AMRAA under the Neurofibromatosis Research Program, titled "DoD Neurofibromatosis Clinical Trial Award" (Funding Opportunity Number W81XWH 16 NFRP CTA). It supported funding instruments including cooperative agreements and grants, was categorized under science and technology/research and development (CFDA 12.420), and eligibility was listed as unrestricted, meaning open to a wide range of entity types unless otherwise limited in the full instructions. The posting and creation date were May 9, 2016, with an application closing date of August 1, 2016, and the listing indicated an expectation of one award.

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