DOD Amyotrophic Lateral Sclerosis, Clinical Outcomes and Biomarkers Award

The Department of Defense’s fiscal year 2025 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Clinical Outcomes and Biomarkers Award (COBA), administered through the Congressionally Directed Medical Research Programs (CDMRP), seeks to advance the development and validation of clinical outcomes and biomarkers to improve clinical trials in ALS. The program is managed by the U.S. Army Medical Research and Development Command (USAMRDC) under delegated authority. Since its inception in 2007, ALSRP has received cumulative appropriations of $269.4 million, with $40 million appropriated for FY25. For this funding cycle, $6.3 million is allocated to support approximately six awards, with a maximum budget of $1 million per award over a three-year period. Funding must be used by September 30, 2031, with awards made no later than September 30, 2026. This grant targets research projects that focus on clinical biomarkers and clinical outcomes. Biomarkers may address areas such as diagnostic, prognostic, phenotypic conversion, disease progression, predictive, or safety parameters. Clinical outcomes may include patient-, clinician-, or observer-reported measures or performance metrics. Projects can be broad or specific to a therapy, class of therapeutics, or ALS subtype. Importantly, all applications that propose biospecimen collection or participant enrollment must include a Community Collaboration plan involving individuals with ALS, family members, caregivers, or community-based organizations to advise throughout the project. Eligible applicants include both intramural and extramural organizations, including academic institutions, for-profits, non-profits, public and private entities, both domestic and international. Independent investigators at all career levels may serve as Principal Investigators (PIs). There is no cost-sharing requirement. Notably, clinical trials are not allowed under this mechanism, though non-interventional clinical research is permitted. Applications follow a two-step process. A pre-application is due by June 6, 2025, via eBRAP, followed by an invitation to submit a full application by July 10, 2025. Full applications are due by August 27, 2025, and undergo a two-tier review process: peer review and programmatic review. Review criteria include scientific rationale, research strategy, feasibility, clinical impact, personnel qualifications, and a robust data and resource-sharing plan. Awards are contingent on compliance with administrative, ethical, and reporting requirements. Required application components include a project narrative, technical and lay abstracts, a statement of work, impact and population statements, a community collaboration plan (if applicable), a data sharing plan, and various administrative forms and representations. Submissions must also address sex as a biological variable and describe access to ALS patient populations or data resources. For assistance, applicants may contact the eBRAP Help Desk at help@eBRAP.org or 301-682-5507, and the Grants.gov Contact Center at support@grants.gov or 800-518-4726. Applications not adhering to program rules, including those missing community collaboration when required, or those proposing clinical trials, will be administratively withdrawn.