DoD Vision Focused Translational Team Science Award

Description

The FY23 VRP FTTSA is intended to support a highly collaborative and translational team initiative that will fundamentally advance the understanding and treatment of eye injury and/or visual dysfunction that result from military exposure (e.g., blast, blunt, thermal, chemical, directed energy trauma).Applicants are encouraged to leverage resources and expertise at the National Center for Advancing Translational Sciences (NCATS) to improve efficiency and accelerate the translational process. A list of NCATS programs and resources supporting preclinical innovation can be found at https://ncats.nih.gov/preclinical.Key aspects of the FTTSA include:. Overarching Challenge: Team science is a collaborative effort that leverages the strengths of investigators specializing in different fields to address an overarching scientific challenge or question. To identify an overarching challenge or question that meets the intent of the FTTSA, investigators are strongly encouraged to consider barrier(s) to and/or gap(s) in the understanding, prevention, diagnosis, mitigation, and/or treatment of eye injury or visual dysfunction associated with military exposure and envision what may be achievable in 10 to 15 years. Based on the long-term expectation, investigators will identify what should and can be achieved in the short term and will design projects and research teams around these goals.. Research Projects› Applications shall include at least three but no more than five distinct research projects that together form a concerted and synergistic effort to address the overarching challenge. Each project, as well as the overall effort, must align with one or more of the FY23 VRP Focus Areas. The potential topics of individual projects are wide-ranging. The examples provided below are illustrative and not exhaustive:. Elucidation of molecular, cellular, and biophysical mechanisms of eye injury or visual dysfunction associated with military exposure. Identification of significant changes in pathophysiology over time after military exposure to inform targeted treatments. Identification of biomarkers and potential therapeutic targets . Development and validation of therapeutic agents and/or devices. Development and validation of drug delivery platforms appropriate for eye injury or visual dysfunction associated with military exposure. Development or improvement of clinically relevant trauma models. Design of protection to mitigate the impact of military exposure on eye and vision. Development of lightweight portable assessment or diagnostic capability› Individual projects must be capable of standing on their own scientific merits. The FY23 VRP FTTSA is not intended to support a series of research projects dependent on the success of any other project. Each project should propose a unique approach to address the overarching challenge and be capable of producing research findings with potential to impact the visual system trauma research field and/or patient care. Preliminary data to support the feasibility of each proposed research project are required.› Individual research projects may focus on any phase of research (e.g., basic, translational, applied, clinical, observational). The FY23 VRP FTTSA allows one of the projects to include a pilot clinical trial (PCT), but not a full-scale clinical trial. In contrast to full-scale clinical trials that are designed to determine safety or efficacy, the purpose of the PCT is to inform the feasibility, rationale, and design of subsequent clinical trials through limited clinical testing of a novel intervention. Applications that do include a PCT as part of the proposed research will have additional submission requirements and review criteria and should demonstrate sufficient understanding of regulatory approval requirements and the regulatory approval process.. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.. Funded PCTs are required to post a copy of the informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in Code of Federal Regulations, Title 32, Part 219 (32 CFR 219). Funded studies are required to register the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov, prior to initiation of the study. Refer to the General Application Instructions, Appendix 1, Section B, for further details.

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