Defense Health Agency Contracting Activity - DHACA

Description

The NFRP Clinical Trial Award supports research 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 by FY15 NFRP. 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 or II trials, both scientific rationale and preliminary data relevant to the proposed clinical trial are required.

Who can apply

• Unrestricted

Contact

CDMRP Help Desk <br/> <br/>Phone: 301-682-5507 <br/>
help@eBRAP.org