DoD VRP, Clinical Trial Award

closed

The FY24 VRP CTA supports the rapid implementation of early-phase clinical trials with the potential to have a significant impact on the treatment or management of service-connected eye injury and visual dysfunction. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Funding from this award mechanism must support a clinical trial. A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) 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. Applicants seeking funding for research that does not meet this definition should consider one of the other FY24 VRP program announcements being offered. For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document_DEC2022.pdf 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. If the proposed clinical trial involves the use of a drug that has not been approved by the relevant Regulatory Agency for the country where the research will be conducted, then submission of an Investigational New Drug (IND) application, or equivalent, that meets all requirements under 21 CFR 312 may be required. It is the responsibility of the applicant to provide evidence from the Institutional Review Board (IRB) of record or the relevant Regulatory Agency if an IND, or equivalent, is not required. If an IND, or equivalent, is required, the regulatory application must be submitted to the relevant Regulatory Agency by the FY24 VRP CTA application submission deadline. In addition, applicants must provide documentation of communication from the Regulatory Agency indicating that the IND, or equivalent, is active/safe to proceed by March 1, 2025, in order for the FY24 VRP CTA application to be considered for funding. Refer to Attachment 10: Regulatory Strategy for further details. The IND, or equivalent, should be specific for the product and indication to be tested in the proposed clinical trial. For more information on IND applications specifically, the FDA has provided guidance at https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application. If the investigational product is a device, then submission of an Investigational Device Exemption (IDE) application, or equivalent, that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence if an IDE, or equivalent, is not required. If an IDE, or equivalent, is required, the regulatory application must be submitted to the relevant Regulatory Agency by the FY24 VRP CTA application submission deadline. In addition, applicants must provide documentation of communication from the Regulatory Agency indicating that the IDE, or equivalent, is active/safe to proceed by March 1, 2025, in order for the FY24 VRP CTA application to be considered for funding. Refer to Attachment 10: Regulatory Strategy for further details. The IDE, or equivalent, should be specific for the device and indication to be tested in the proposed clinical trial. The proposed clinical trial is expected to begin no later than 6 months after the award date.