DoD Spinal Cord Injury Clinical Trial Award | Apply Online

Opportunity Summary:

The DoD Spinal Cord Injury Research Program (SCIRP) Clinical Trial Award is a Department of the Army (USAMRAA) funding opportunity designed to move promising spinal cord injury (SCI) interventions into the clinic quickly. Its purpose is to support the rapid startup and execution of Phase 0, Phase I, or Phase II clinical trials that could meaningfully improve the treatment or day-to-day management of SCI and related complications. A key point is that this mechanism is strictly for clinical trials in human participants; funds cannot be used for preclinical or animal studies. The program uses a straightforward definition of a clinical trial: a prospective study that enrolls human subjects to test an intervention (such as a drug, biologic, device, surgery, rehabilitation approach, or behavioral intervention) and measures outcomes tied to safety, feasibility, effectiveness, or efficacy as a direct result of that intervention.

The award emphasizes readiness and speed. Proposed trials are expected to begin within 12 months of the award date, which means applicants need to demonstrate that the protocol, sites, staffing, and logistics are realistically positioned to launch. The intervention being tested must have a clear and compelling potential impact for people living with SCI, and the trial should be directly relevant to the health care needs of military Service members, Veterans, or others affected by SCI. Applications are expected to be grounded in a solid scientific rationale built from critical analysis of existing literature, not speculation. The program also requires preliminary data that directly support the trial concept, and it raises the evidentiary bar for Phase II proposals by requiring Phase I or pilot clinical trial data to justify moving forward.

Regulatory preparedness is treated as a make-or-break element. If the trial uses an investigational drug not approved by the FDA for the proposed use, an Investigational New Drug (IND) submission to the FDA may be required and must be submitted before the grant application is filed. Similarly, if the trial uses an investigational device not approved or cleared for the intended clinical use, the project may need to comply with Investigational Device Exemption (IDE) rules, and the IDE application must also be submitted prior to grant submission when applicable. Even after an award is made, the Government can withdraw funding if documented IND or IDE status is not obtained within six months of the award date, reinforcing that applicants must be prepared to clear regulatory hurdles quickly.

From a study design standpoint, the announcement signals what reviewers will look for in a credible, actionable trial plan. Applicants need to show they have access to an appropriate patient population and can recruit enough participants to reach meaningful endpoints; this includes explaining accrual strategies and acknowledging how standards of care at participating sites might affect eligibility, recruitment, and outcomes. They must document access to the intervention materials themselves, whether that is the drug supply, device availability, or any other required components. Trials should define clear endpoints and, when possible, use standard outcome measures to support interpretability and comparability. A detailed statistical analysis plan is expected, backed by appropriate statistical expertise and a power analysis that connects the sample size to the trial objectives so the study can credibly answer its main questions.

Operational capability and project governance are also emphasized. The application is expected to include dedicated study coordination to manage Institutional Review Board (IRB) submissions, other regulatory steps, multi-site coordination when relevant, and hands-on oversight of participant recruitment. Strong institutional support needs to be evident, signaling that the applicant organization will provide the environment and resources required to run a clinical trial. The program encourages partnerships, particularly collaborations between clinicians and bioengineers, reflecting the translational nature of many SCI interventions.

A notable requirement is planning for what happens after the trial. Applicants must include a Transition Plan describing how the intervention will move forward if the trial is successful, whether that means advancing to the next clinical phase, preparing for broader deployment, or progressing toward market delivery. Data standards also matter: applicants are expected to use the SCI Common Data Elements (CDE) standards developed by leading SCI organizations and NINDS to promote consistent, reusable data. The Government may also designate data repositories for archiving, with any associated submission costs handled during award negotiations.

Administrative details in the notice indicate this was a discretionary funding opportunity offered as a cooperative agreement or grant under CFDA 12.420 (Military Medical Research and Development), with no cost sharing requirement and unrestricted eligibility (open to any applicant type, subject to any additional eligibility language in the full announcement). For this specific posting (Funding Opportunity Number W81XWH-13-SCIRP-CTA), the estimated total funding was about $7.2 million with an expectation of roughly three awards. The original posting date was May 24, 2013, and the closing date listed was October 16, 2013, with the opportunity archived November 15, 2013.

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