DoW Amyotrophic Lateral Sclerosis Research Program, Clinical Outcomes and Biomarkers Award

The Amyotrophic Lateral Sclerosis Research Program Clinical Outcomes and Biomarkers Award is a federal funding opportunity administered through the Defense Health Agency Contracting Activity under the Congressionally Directed Medical Research Programs as part of the Amyotrophic Lateral Sclerosis Research Program. The funding opportunity supports the development and validation of clinical outcomes and biomarkers intended to improve and enrich clinical trials in amyotrophic lateral sclerosis. The program was originally established by Congress in 2007 to support high-impact ALS research, and the FY26 appropriation for the ALSRP totals $40 million. The funding mechanism specifically focuses on biomarkers and clinical outcomes that can improve disease progression monitoring, prognostic assessment, therapeutic response evaluation, subtype identification, and other clinically meaningful applications relevant to ALS treatment development. The program mission is to accelerate translational research that improves outcomes and advances cures for people living with ALS, including military Service Members, Veterans, their families, and the broader public. The Clinical Outcomes and Biomarkers Award supports projects involving clinical biomarkers, clinical outcomes, or both. Biomarker projects may involve susceptibility, diagnostic, predictive, prognostic, pharmacodynamic, response, safety, or disease progression biomarkers that are specific to ALS rather than general neurological disease. Clinical outcomes projects may involve clinician-reported, observer-reported, patient-reported, or performance-based outcome measures that can support ALS clinical trial success metrics. The funding announcement also encourages the use of digital health technologies such as wearable devices, smartphone sensors, imaging tools, video and voice recordings, and other digital physiological monitoring approaches. Projects may focus broadly across ALS populations or specifically target defined ALS subtypes, including genetic mutations or therapeutic cohorts. The funding opportunity strongly encourages the use of existing ALS datasets, biorepositories, registries, omics datasets, and patient-based resources, including collaborations involving Department of War or Department of Veterans Affairs resources when appropriate. The program places substantial emphasis on community collaboration and translational relevance. Applicants are required to incorporate meaningful engagement from the ALS lived experience community throughout the planning and execution of the project. Community collaboration may include participation from people living with ALS, family members, caregivers, community-based organizations, or formal community advisory boards. These collaborators are expected to contribute to research design, implementation, dissemination, and project evaluation rather than serving only as passive advisors. Applications involving patient recruitment, biospecimen collection, clinical outcomes research, or digital data collection must demonstrate especially strong integration of community collaborators throughout the research lifecycle. The funding opportunity also emphasizes rigorous study design, reproducibility standards, regulatory planning, and long-term progression toward clinical implementation or qualification pathways. Approximately $7 million is expected to be allocated to support about seven awards. Each award may request up to $1 million in total costs over a maximum three-year performance period. The opportunity does not require cost sharing or matching contributions. Indirect costs may be requested according to negotiated institutional rates, and collaborating organizations may also include indirect costs consistent with their own negotiated agreements. The program permits funding for limited travel related to scientific dissemination and collaboration activities but restricts excessive scientific meeting travel beyond specified limits. Clinical trials are explicitly prohibited under this funding mechanism, although noninterventional clinical research studies and prospective biospecimen or data collection efforts are allowed. The awards are expected to be funded using FY26 appropriations and are anticipated to be issued no later than September 30, 2027. The submission process involves a mandatory two-step application sequence. Applicants must first submit a pre-application through the Electronic Biomedical Research Application Portal. Pre-applications require a three-page preproposal narrative addressing use of ALS clinical resources, biomarker development objectives, data sharing plans, clinical impact, and community collaboration integration. Supporting documentation includes references, abbreviations, and biographical sketches. Following review of pre-applications, selected investigators will receive invitations to submit full applications. Full applications require extensive materials including a project narrative, technical and lay abstracts, statement of work, clinical impact statement, regulatory strategy, progression plan, data and resource sharing plan, community collaboration plan, supporting documentation, population statements where applicable, and detailed budget information. Extramural applicants submit full applications through Grants.gov while intramural Department of War organizations submit through eBRAP. Applications undergo both peer review and programmatic review. Peer review emphasizes research strategy, feasibility, scientific rationale, clinical impact, personnel qualifications, regulatory progression planning, and data sharing approaches. Applications are also evaluated on rigor, statistical design, incorporation of sex as a biological variable, reproducibility, feasibility of patient recruitment, and the strength of community collaboration. Programmatic review additionally considers alignment with ALSRP priorities, overall portfolio composition, and relative impact potential. Key submission deadlines include a pre-application deadline of June 24, 2026, invitation notifications anticipated on August 3, 2026, and a full application deadline of September 30, 2026. Peer review is expected in November 2026, followed by programmatic review in January 2027. Contact support is available through the eBRAP Help Desk at help@eBRAP.org and the Grants.gov Support Center at support@grants.gov.

Strong applications clearly define biomarker context of use and regulatory relevance; integrate meaningful ALS community collaboration throughout planning and execution; demonstrate rigorous statistical power and reproducibility; provide strong data sharing plans using curated ALS repositories; explain progression toward future clinical implementation and regulatory qualification; emphasize relevance to Service Members Veterans and their Families.