DoD Clinical and Rehabilitative Medicine Assistive Technologies Research Award

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The DMRDP Assistive Technologies Research Award (ATRA) is intended to support research focused on novel technologies with the potential to have a major impact on the restoration of vision, hearing, and/or balance following traumatic injuries. Studies can range from proof of concept (i.e. first in human) trials through Phase II clinical trials, as well as Class I, II, or III medical device trials/testing. The specific focus area of this award is on restorative and rehabilitative assistive technologies for sensory substitution/augmentation of vision, hearing, and/or balance. Studies involving drugs or biologics are not allowed. All studies must be responsive to the health care needs of military Service Members and Veterans, and all applications must specifically and clearly address the military relevance of the proposed research; however, the use of military populations in the proposed research is not a requirement. Proposed projects should be designed to demonstrate the effectiveness and further evaluate the safety of novel assistive technologies for sensory substitution/augmentation in human patients suffering from serious, debilitating visual, auditory, and/or vestibular injuries due to trauma. The purpose of such demonstrations is to accelerate translation of greater medical capabilities to patients. Funding from this award mechanism must support a clinical trial and cannot be used for preclinical research studies. Each application should propose only one clinical trial with a distinct study design. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. The term “human subjects” is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information on clinical research, refer to the Human Subject Resource Document provided at https://cdmrp.org/Program_Announcements_and_Forms/. If the proposed study involves the use of an investigational device that has not been approved by the US Food and Drug Administration (FDA) for its investigational clinical use, the study may be required to comply with FDA Investigational Device Exemption (IDE) regulations. If applicable, evidence that an IDE has been submitted or will be submitted within 60 days of the award date, or that the device is exempt from an IDE, is required. The Government reserves the right to withdraw funding if an IDE required for conduct of the proposed research has not been acquired within 6 months of the award date. The following are important aspects of submission for the Assistive Technologies Research Award: • The proposed clinical trial is expected to begin no later than 12 months after the award date. • Inclusion of preliminary data relevant to the proposed research project is required. • The proposed research project must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature. • The application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. The PI should discuss how accrual goals will be achieved and how standards of care may impact the study population. • The application should demonstrate documented availability of and access to the technology or device needed, as appropriate. • The proposed clinical trial should include clearly defined and appropriate endpoints. • The application should include a clearly articulated statistical analysis plan, appropriate statistical expertise, and a power analysis reflecting sample size projections that will clearly answer the objectives of the study. • The application should include a study coordinator(s) who will guide the clinical protocol through the local Institutional Review Board (IRB) of record and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. • The application must provide evidence that an IDE has been submitted, or will be submitted within 60 days of the award date, or that the device is exempt from an IDE. • The application should include a Transition Plan (including potential funding and resources) showing how the product will progress to the next clinical trial phase and/or delivery to the market after the successful completion of the FY13 Assistive Technologies Research Award. • The application should demonstrate evidence of institutional support.

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