DoD Forward Surgical and En Route Care

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This Program Announcement/Funding Opportunity is focused on specific research topics ofThe Combat Casualty Care Research Program as outlined in Section B. Investigators must demonstrate logical reasoning and a sound scientific rationale established through a critical review and analysis of the literature for the proposal to be competitive. Research projects should include a well-formulated, testable hypothesis based on a strong scientific rationale. This award mechanism is focused on applied research, defined as research that refines concepts and ideas into potential solutions to military health and performance problems with a view toward evaluating technical feasibility; includes studies and investigations leading to candidate solutions in preparation for initial human testing. This award mechanism will also support advanced technology development which is defined as research for the development of candidate solutions and components of early prototype systems for test and evaluation. Promising drug and vaccine candidates and medical devices and technologies are selected for initial safety and efficacy testing in small scale human clinical trials. Applications may include phase I or early phase II clinical trials, but not late phase II large-scale effectiveness clinical trials or advanced development of products and capabilities. Preliminary data are required for applied research and advanced technology development applications. Awards may not be used to support fundamental basic research, defined as research directed toward attaining a greater knowledge and understanding of fundamental principles of science and medicine relevant to the improvement of medical care in operationally relevant environments.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 exploratoryinformation, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction.

High