DoD Peer Reviewed Orthopaedic Applied Research Award

archived

The PRORP Applied Research Award (ARA) mechanism is being offered for the first time in FY15. The PRORP ARA seeks applied research applications focused on advancing optimal treatment and restoration of function for military personnel with musculoskeletal injuries sustained during combat or combat-related activities. It is expected that any research findings would also provide benefit to the general population. To meet the intent of the award mechanism, applications must specifically address one of the FY15 PRORP ARA Focus Areas listed above. Awards may not be used to support fundamental basic research. Basic research is defined as research directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications toward process or products in mind. The FY15 PRORP ARA is focused on applied research, defined as work that refines concepts and ideas into potential solutions with a view toward evaluating technical feasibility of promising new products, pharmacologic agents, behavioral and rehabilitation interventions, diagnostic and therapeutic techniques, clinical guidance, and/or emerging approaches and technologies. Upon successful completion, these studies are expected to yield potential health products, approaches, or technologies positioned for human testing. Presentation of preliminary data is required. Inclusion of preliminary and/or published data relevant to the research question is required. In addition, investigators must demonstrate logical reasoning. In order to be competitive, the application must include a sound scientific rationale and a well formulated, testable hypothesis established through a critical review and analysis of the literature. Studies allowed under the FY15 PRORP ARA may include, but are not limited to: • Refinement of concepts and ideas into potential solutions with a view toward evaluating technical feasibility of emerging approaches, technologies, and promising new products. • Evaluation, maturation, and/or down-selection of potential product candidates (drugs, biologic constructs, or devices/systems) in vitro and/or in vivo. • Conducting preclinical safety and/or toxicity studies sufficient to support Investigational New Drug/Investigational Device Exemption (IND/IDE) applications. • Preparation activities needed to support a future clinical trial or regulatory submission. Awards may not be used to support clinical trials. 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. For more information on how to distinguish clinical research from clinical trials, see the Human Subject Resource Document at https://ebrap.org/eBRAP/public/Program.htm. Investigators seeking support to conduct a clinical trial should apply to the PRORP Clinical Trial Award (W81XWH-15-PRORP-CTA) mechanism, which can be accessed at http:cdmrp/army.mil/funding. Research Scope: Research proposed under the FY15 PRORP ARA may include small- to large-scale projects such as nonclinical efficacy studies, effective comparison studies, human use and/or observational studies. Two different funding levels, based on the scope of the research, are available under this Program Announcement/Funding Opportunity. It is the responsibility of the Principal Investigator (PI) to select the funding level that is most appropriate for the proposed research project. The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under each funding level: • Funding Level 1: Research that is already supported by preliminary data and has the potential to make significant advancements toward clinical translation. Demonstration of efficacy in in vivo models, as applicable. • Funding Level 2: Advanced translational studies that have the potential for near-term clinical investigation.

High