DoD Neurofibromatosis Clinial Trial Award

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The NFRP Clinical Trial Award mechanism was first offered in FY99. Since then, 40 Clinical Trial Award applications have been received, and 11 have been recommended for funding.The NFRP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a major impact on the treatment or management of NF. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept (i.e., pilot, first in human, or Phase 0) trials to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.Funding from this award mechanism must support a clinical trial and may not be used for preclinical research studies. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other award mechanisms/funding opportunities being offered. The term “human subjects” is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm.For Pilot trials inclusion of scientific rationale and/or preliminary data relevant to the proposed pilot clinical trial is required.For Phase I, II trials, scientific rationale and preliminary data relevant to the proposed clinical trial are required.

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