The FY23 VRP CTA supports the rapid implementation of early-phase clinical trials (i.e., phase 0 through phase 2a) of new interventions 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 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.
Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other FY23 VRP program announcements being offered. Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.
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 FDA for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) may be required. The IND application should be specific for the product (i.e., the product should not represent a derivative or alternate version of the investigational agent described in the IND application) and indication to be tested in the proposed clinical trial. For more information on IND applications, 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 an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 may be required. The IDE application should be specific for the device (i.e., should not represent a derivative or modified version of the device described in the IDE application) and indication to be tested in the proposed clinical trial.
It is the responsibility of the applicant to provide evidence if an IND or IDE application is not required or the device qualifies for an abbreviated IDE application.
If an IND or IDE application is required, the IND or IDE application must be submitted to the FDA by the FY23 VRP CTA application submission deadline. In addition, applicants must provide documentation of communication from the FDA indicating that the IND or IDE application is active/safe to proceed by March 1, 2024, in order for the FY23 VRP CTA application to be considered for funding. Refer to Attachment 9: Regulatory Strategy for further details.
If the clinical trial of an investigational product will be conducted at international sites, documentation of communication with the national regulatory agency of the host country(ies) indicating the investigational product is active/safe to proceed is required by March 1, 2024.
The proposed clinical trial is expected to begin no later than 6 months after the award date.
Funded trials 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 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.
The types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the DOD during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.
