DOD Spinal Cord Injury Clinical Trial Award | Apply Online

Opportunity Summary:

The DOD Spinal Cord Injury Clinical Trial Award (SCIRP CTA) is a Department of the Army (USAMRAA) funding opportunity under the Congressionally Directed Medical Research Programs that is designed specifically to push promising spinal cord injury (SCI) interventions into early-stage human testing quickly. Originally introduced in FY09 as the Clinical Trial Award - Rehabilitation, it was expanded in FY12 so it is no longer limited to rehabilitation-focused projects. Instead, it supports rapid implementation of Phase 0, Phase I, or Phase II clinical trials aimed at meaningfully improving the treatment or management of SCI and the secondary consequences that often follow injury. For FY12, the program notes a particular interest in comparative effectiveness studies, meaning trials that directly compare approaches to determine which works better for real-world patient care.

A central feature of this mechanism is that the funding must be used for an actual clinical trial and cannot be used for preclinical work. The opportunity defines a clinical trial as a prospective study that enrolls human participants and tests an intervention (such as a device, drug, biologic, surgical procedure, rehabilitation method, behavioral intervention, or similar approach) with measurable outcomes tied to safety, effectiveness, or efficacy. The intent is to produce outcomes that reflect a direct effect of the intervention on the participant. Applicants proposing animal studies, bench research, or other preclinical development are directed to seek different SCIRP funding mechanisms instead.

Because this award is built around near-term execution, applicants are expected to be ready to move. The proposed trial is expected to start within 12 months after the award date, and the application needs to show that the study is feasible on that timeline. Reviewers are looking for interventions with strong potential impact for people living with SCI, and the trial must be clearly relevant to the health care needs of military Service members and Veterans, while also serving the broader SCI community. The project needs a sound scientific rationale grounded in a critical review of existing literature, and preliminary data are required. If the application is for a Phase II clinical trial, the expectation is that Phase I or pilot clinical trial data will already exist and be included to justify scaling to a larger efficacy-oriented study.

Feasibility and operational readiness are emphasized throughout the submission requirements. Applicants must demonstrate access to a suitable study population and explain how enrollment targets will realistically be met, including how existing standards of care could affect recruitment or outcomes. They also must document that they have access to the intervention itself, whether that is a specific drug or compound, a device, or other required materials. The trial design must include clear endpoints and, where appropriate, standard outcome measures. A credible statistical analysis plan is expected, including appropriate statistical expertise and a power analysis that ties the sample size directly to the study objectives and the questions the trial is meant to answer.

Regulatory planning is treated as a make-or-break issue for studies involving unapproved drugs or investigational devices. If a drug is not FDA-approved for the proposed investigational use, an Investigational New Drug (IND) application may be required and, if applicable, must be submitted before the grant application is submitted. Similarly, investigational devices may need to comply with FDA Investigational Device Exemption (IDE) requirements, and the IDE must be submitted prior to application submission when applicable. Even after award, the government reserves the right to withdraw funding if documented IND/IDE status is not obtained within six months of the award date, reinforcing the expectation that applicants have already mapped out and initiated the necessary regulatory path.

The program also expects strong clinical execution capacity. Applications should include dedicated study coordinator support to shepherd the protocol through the Institutional Review Board (IRB) and other regulatory approvals, manage coordination across any participating sites, and support participant accrual. The PI is expected to bring appropriate clinical expertise, and there must be evidence of institutional support to show the organization is positioned to run the study successfully. The DOD also encourages partnerships between clinicians and bioengineers, reflecting the mix of therapeutic, device-based, and technology-enabled approaches common in SCI care.

Another key requirement is a Transition Plan that explains what happens after the SCIRP-funded trial ends. This plan should lay out how the intervention will progress to the next clinical phase and/or move toward market delivery if results are positive, including realistic sources of future funding and resources. In other words, the award is not meant to fund an isolated study; it is meant to move an intervention along a credible development pathway toward broader clinical availability.

Data standards and sharing are also built into the expectations. Applicants are encouraged to use the SCI Common Data Element (CDE) standards developed through collaboration among the International Spinal Cord Society, the American Spinal Injury Association, and the NINDS CDE team. In addition, the government may designate data repositories for archiving, and any submission costs would be handled during award negotiations. This focus supports consistency across studies and improves the long-term value and comparability of trial data generated with federal funds.

On the administrative side, this FY12 opportunity (Funding Opportunity Number W81XWH-12-SCIRP-CTA) is a discretionary program using a cooperative agreement funding instrument, in the science and technology / research and development category. It anticipated about three awards with an estimated total funding amount of $3.6 million, did not require cost sharing, and was open to unrestricted applicant types (subject to any eligibility clarifications in the full announcement). Key dates listed include a posted date of May 31, 2012 and a closing date of October 1, 2012. For access issues, applicants were directed to the CDMRP Help Desk at 301-682-5507.

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Next opportunity: SPACE TECHNOLOGY RESEARCH OPPORTUNITIES EARLY STAGE INNOVATIONS

Previous opportunity: DoD Spinal Cord Injury Investigator Initiated Research Award

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