DoD Vision Translational Research Award

Description

The FY23 VRP TRA is intended to support translational research that moves promising discoveries into clinical applications that will advance the prevention, diagnosis, mitigation, and/or treatment of eye injury or visual dysfunction associated with military exposure.Successful applications to the FY23 VRP TRA should establish a clear path to transforming a promising discovery into new drugs, devices, or clinical practice guidelines that are ready for definitive testing in clinical trials. For new drug or device development, the investigative team should include at least one collaborator with expertise in the regulatory approval process.For the purposes of this funding opportunity, “regulatory agency” refers to the U.S. Food and Drug Administration (FDA) or any relevant international regulatory agency unless otherwise noted.It is expected that, if applicable, an Investigational New Drug (IND)/ Investigational Device Exemption (IDE) application or international equivalent will be submitted to a regulatory agency during or by the end of the period of performance.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.The National Cancer Institute’s Translational Research Working Group (TRWG) conceptualized translational research as a set of developmental pathways leading to various clinical goals (http://clincancerres.aacrjournals.org/content/14/18/5664). Applicants may consult the TRWG pathways for guidance on the design of translational research projects.Research involving animals, human subjects, and human anatomical substances is permitted. The FY23 VRP TRA allows funding for a pilot clinical trial (PCT) component, 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 include a PCT component must also have non-PCT translational research component(s) (e.g., preclinical studies, non-PCT clinical studies) and will have additional submission requirements and review criteria.

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