DoW Spinal Cord Injury, Clinical Trial Award

The Spinal Cord Injury Research Program Clinical Trial Award is administered through the Defense Health Agency Contracting Activity under the Congressionally Directed Medical Research Programs as part of the fiscal year Spinal Cord Injury Research Program portfolio. The program is intended to support rapid implementation and analysis of clinical trials that can significantly improve treatment or management strategies for spinal cord injury. The opportunity emphasizes clinically meaningful outcomes for military Service Members, Veterans, and civilians living with spinal cord injury, while also encouraging multidisciplinary collaboration among academic institutions, industry, the Department of War, the Department of Veterans Affairs, and other government partners. The program’s mission is to advance more effective strategies that improve health and quality of life for individuals with spinal cord injury, and the vision centers on improving treatment, rehabilitation, and long-term management of spinal cord injury and its consequences. The award supports only clinical trial research and specifically excludes preclinical research activities. Proposed studies may include proof-of-concept, pilot, first-in-human, phase 0, or larger-scale efficacy trials involving drugs, biologics, devices, rehabilitation interventions, psychosocial approaches, surgical methods, or emerging technologies. Alternative and decentralized clinical trial models are encouraged when appropriate for participant recruitment, communication, intervention delivery, or data collection. Projects must align with at least one identified priority area, including Acute Injury Intervention, Secondary Health Effects, Psychosocial Well-Being, or Rehabilitation and Regeneration. Each proposal must also address a corresponding near-term programmatic goal and describe how the project could eventually contribute to long-term adoption into the standard of care for spinal cord injury management or treatment. Funding is available for approximately two awards with a total program allocation of about $9.76 million. Applications submitted under the standard single principal investigator structure may request up to $4.8 million in total costs over a maximum four-year period of performance. Applications submitted through the Early-Career Partnership Option may request up to $4.96 million in combined total costs across two linked applications. The opportunity specifically requires that at least one investigator in the Early-Career Partnership Option meet the defined early-career eligibility criteria. Awards are expected to be issued no later than September 30, 2027. The announcement states that cost sharing is not required. Allowable costs include participant reimbursement, travel related to collaborations, data sharing activities, community engagement activities, and limited scientific meeting attendance. Costs related to preclinical work or excessive conference travel are not allowable. Eligibility is broad and includes domestic and foreign organizations, nonprofit and for-profit entities, public and private institutions, and intramural Department of War organizations. Investigators may apply regardless of nationality or citizenship status if affiliated with an eligible organization. However, an investigator may only serve as principal investigator on one application submitted to this specific award mechanism during the fiscal year cycle. Applications are required to include at least two spinal cord injury community partners such as lived-experience consultants or representatives of community-based organizations. The opportunity strongly emphasizes community-informed research and expects applicants to demonstrate equitable collaboration with individuals directly affected by spinal cord injury throughout planning, implementation, dissemination, and evaluation activities. The submission process is conducted in two stages. First, applicants must submit a pre-application through the Electronic Biomedical Research Application Portal. The pre-application includes a two-page narrative describing the rationale, aims, study design, military relevance, and anticipated impact of the proposed clinical trial. If invited to continue, applicants then submit a full application either through Grants.gov for extramural organizations or through eBRAP for eligible intramural organizations. Full applications require extensive documentation including a project narrative, technical and lay abstracts, statement of work, study population recruitment and safety plan, regulatory strategy, personnel and management plans, long-term implementation strategy, and a community collaboration plan. Applications involving investigational products requiring an Investigational New Drug or Investigational Device Exemption submission must provide evidence that the regulatory submission was filed before the full application deadline. Applications undergo a two-tier review process consisting of peer review followed by programmatic review. Peer reviewers evaluate study design, feasibility, clinical impact, statistical planning, personnel qualifications, recruitment strategies, long-term implementation planning, and community collaboration. Additional review considerations include ethical protections, regulatory readiness, research sharing plans, budget appropriateness, and institutional environment. Programmatic reviewers then consider portfolio balance, military relevance, alignment with program priorities, and overall impact. Applications that fail to meet mandatory requirements, including inclusion of two community partners or submission of required attachments, may be administratively withdrawn. The current cycle includes a pre-application deadline of August 3, 2026, followed by invitations to submit full applications on September 18, 2026. Full applications are due November 12, 2026, with an application verification period ending November 16, 2026. Peer review is anticipated in January 2027 and programmatic review is expected in March 2027. The opportunity appears to follow an annual federal funding cycle associated with fiscal year appropriations. Questions regarding the application process may be directed to the eBRAP Help Desk at help@eBRAP.org or 301-682-5507, while Grants.gov technical support is available at support@grants.gov or 800-518-4726. The announcement requires active registrations in SAM.gov, Grants.gov, and eBRAP before submission activities begin.

Demonstrate strong clinical relevance to SCI priority areas; integrate lived-experience community input throughout study design and implementation; clearly justify feasibility and recruitment strategy; provide strong long-term pathway toward standard-of-care adoption; emphasize military relevance and rigorous trial methodology.