DoW Vision, Clinical Trial Award

<p><strong>Summary:</strong> The fiscal year 2026 (FY26) Vision Research Program (VRP) Clinical Trial Award (CTA) supports the rapid implementation of <a href="https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in" target="_blank">clinical trials</a> with the potential to have a significant impact on the treatment or management of service-connected eye injury and visual dysfunction. Research must align with at least one of the <a href="https://militaryhealth-my.sharepoint-mil.us/personal/teresa_m_parkerreeser_civ_health_mil/Documents/Documents/FY%202026/VRP/HT942526VRPCTA_GG.docx#Focus_Area" target="_blank">FY26 VRP Focus Areas</a>. <strong style="color: rgb(0, 176, 80);"><em> </em></strong></p> <p><strong>Distinctive Features: </strong></p> <p>·       For interventions that require Investigational New Drug (IND)/Investigational Device Exemption (IDE) or equivalent regulatory authorizations for clinical testing, the IND/IDE application or equivalent <strong>must be submitted to the relevant </strong><a href="https://militaryhealth-my.sharepoint-mil.us/personal/teresa_m_parkerreeser_civ_health_mil/Documents/Documents/FY%202026/VRP/HT942526VRPCTA_GG.docx#RegulatoryAgency" target="_blank"><strong>Regulatory Agency</strong></a><strong> by the CTA application submission deadline.</strong> In addition,<strong> applicants must provide documentation of communication from the Regulatory Agency indicating that the IND/IDE or equivalent is active/safe to proceed by March 1, 2027, in order for the CTA application to be considered for funding.<em> </em></strong>Refer to <a href="https://militaryhealth-my.sharepoint-mil.us/personal/teresa_m_parkerreeser_civ_health_mil/Documents/Documents/FY%202026/VRP/HT942526VRPCTA_GG.docx#Attach9_RegStrategy" target="_blank">Attachment 7: Regulatory Strategy</a> for further details.</p> <p>·       Scored<strong> </strong><a href="https://militaryhealth-my.sharepoint-mil.us/personal/teresa_m_parkerreeser_civ_health_mil/Documents/Documents/FY%202026/VRP/HT942526VRPCTA_GG.docx#Peer_Review" target="_blank"><strong>peer review criteria</strong></a> include Clinical Impact; Research Strategy and Feasibility; Recruitment, Accrual, Retention; Regulatory Strategy and Transition Plan; Statistical Plan and Data Analysis; Ethical Considerations; Personnel and Communication.</p> <p>·       <a href="https://militaryhealth-my.sharepoint-mil.us/personal/teresa_m_parkerreeser_civ_health_mil/Documents/Documents/FY%202026/VRP/HT942526VRPCTA_GG.docx#Programmatic_Review" target="_blank"><strong>Programmatic review criteria</strong></a> include adherence to the intent of the CTA, contribution to program portfolio, relative impact and relevance to military health.</p> <p><br></p> <p><a href="https://cdmrp.health.mil/pubs/press/2026/vrppreann " target="_blank">https://cdmrp.health.mil/pubs/press/2026/vrppreann </a></p>