The Department of Defense (DoD), through its Congressionally Directed Medical Research Programs (CDMRP), has issued the FY25 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Clinical Outcomes and Biomarkers Award (COBA). This initiative is managed by the U.S. Army Medical Research and Development Command (USAMRDC) and seeks to fund research projects that aim to develop and validate clinical outcomes and biomarkers specifically to enhance ALS clinical trials. The ALSRP was established by Congress in 2007, with a cumulative appropriation of $269.4 million through FY24. For FY25, an additional $40 million has been appropriated.

This award targets studies that focus on clinical biomarkers or clinical outcomes—or both. Biomarkers may relate to susceptibility, diagnostic, monitoring, prognostic, predictive, response, or safety. Clinical outcomes may include clinician-, observer-, patient-reported, or performance outcomes. Use of digital health technologies such as wearables, smartphone sensors, and imaging is encouraged. The award aims to facilitate high-impact research using well-curated data and resources and promotes collaboration with community partners such as people living with ALS, caregivers, or advocacy organizations.

The funding cap for direct costs is $750,000 per award with a maximum period of performance of three years. Approximately $6.2 million is allocated for about five awards. Projects must not be clinical trials, though clinical research involving human data or biospecimens is allowed. Prospective patient enrollment or biospecimen collection must incorporate a Community Collaboration plan.

Eligible applicants include both domestic and foreign organizations, whether nonprofit, for-profit, academic, or governmental, excluding DoD entities. Principal Investigators (PIs) at all career stages and of any citizenship may apply. Cost sharing or matching is not required. Applications must be submitted in two stages: a pre-application via eBRAP by June 6, 2025, and, if invited, a full application via Grants.gov by August 27, 2025. Peer and programmatic reviews will follow, with award announcements expected by the end of 2025 and funding no later than September 30, 2026.

Applications must include specific components such as technical and lay abstracts, a project narrative, letters of support, and a data and resource sharing plan. The review process will evaluate the scientific rationale, feasibility, clinical impact, and community collaboration. Contact points for application assistance include eBRAP (help@eBRAP.org, 301-682-5507) and Grants.gov (support@grants.gov, 800-518-4726).