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

DoD Amyotrophic Lateral Sclerosis Research Program, Clinical Outcomes and Biomarkers Award is sponsored by Dept. of the Army -- USAMRAA. This opportunity supports mission-aligned projects and measurable outcomes.

DOD Amyotrophic Lateral Sclerosis, Clinical Outcomes and Biomarkers Award | HT942525ALSRPCOBA DOD Amyotrophic Lateral Sclerosis, Clinical Outcomes and Biomarkers Award | HT942525ALSRPCOBA Science and Technology and other Research and Development Dept.

of the Army -- USAMRAA Opportunity Information: Apply for HT942525ALSRPCOBA The FY25 DOD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Clinical Outcomes and Biomarkers Award (COBA) is a discretionary research grant opportunity administered by the Department of the Army through USAMRAA.

Its purpose is to strengthen ALS clinical trials by supporting projects that develop and/or validate better clinical outcome measures and biomarkers. The program is aimed at work that can make trials more informative, efficient, and interpretable, for example by improving how disease progression is tracked, how patients are stratified, or how treatment response and safety are measured.

Importantly, proposed tools do not need to be universally applicable to every ALS patient; the announcement explicitly allows projects tailored to a specific therapy, a class of therapeutics, or a defined ALS subtype such as a particular genetic mutation. Applicants must address one or both of two focus areas.

The first focus area is Clinical Biomarkers, which covers identification, development, and/or validation of promising ALS biomarkers. The announcement is intentionally broad about biomarker types and includes susceptibility or risk biomarkers, diagnostic biomarkers, monitoring or disease progression biomarkers, prognostic biomarkers, predictive biomarkers, response biomarkers, and safety biomarkers.

In practical terms, this can include work that helps determine who is likely to develop ALS, supports earlier or more accurate diagnosis, tracks progression over time with greater sensitivity than existing tools, predicts clinical trajectory, identifies which patients are more likely to benefit from a given therapy, shows whether a therapy is working, or flags adverse effects.

The second focus area is Clinical Outcomes, which supports identification, development, and/or validation of outcome measures that can be used in ALS studies and trials. These outcomes can be clinician-reported, observer-reported (such as caregiver inputs), patient-reported outcomes, and/or performance-based measures.

The scope includes not only completely new instruments but also efforts to refine and optimize outcome measures already in use, which could involve improving reliability, sensitivity to change, feasibility in multicenter settings, or relevance to patient priorities.

The overarching intent is to produce outcome measures that more accurately reflect meaningful change in ALS and that can be deployed in clinical research to evaluate interventions. Across both focus areas, the opportunity permits the use of digital health measures.

This includes wearables, smartphone sensors, video or voice recordings, imaging studies, and other devices that capture disease-relevant physiological data or functional outcomes. This flexibility signals interest in modern measurement approaches that can potentially provide higher-frequency data, reduce patient burden, capture real-world function, or detect subtle changes that conventional clinic-based assessments may miss.

A distinctive requirement applies to projects that involve prospective biospecimen collection or participant enrollment: those applications must incorporate a Community Collaboration as described in the solicitation’s Attachment 9.

In effect, if a project is going to collect new samples or enroll people prospectively, the proposal needs to include a structured collaboration with the relevant community, reflecting an expectation for meaningful engagement and partnership rather than purely researcher-driven recruitment or collection.

From an administrative standpoint, the opportunity number is HT942525ALSRPCOBA, the funding instrument is a grant, and the activity category is Science and Technology and other Research and Development (CFDA 12. 420). Eligibility is listed as unrestricted, and the original closing date is August 27, 2025.

The announcement anticipates making about five awards, with the award ceiling not specified in the provided excerpt. The Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled " DOD Amyotrophic Lateral Sclerosis, Clinical Outcomes and Biomarkers Award " and is now available to receive applicants.

Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12. 420 . This funding opportunity was created on 2025-04-18.

Applicants must submit their applications by 2025-08-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.) The number of recipients for this funding is limited to 5 candidate(s).

Eligible applicants include: Unrestricted. Apply for HT942525ALSRPCOBA [Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: Your browser does not support the video tag. FY25 DOD ALSRP Clinical Outcomes and Biomarkers Award (COBA) FAQs 1) What is the FY25 DOD ALSRP Clinical Outcomes and Biomarkers Award (COBA)?

The FY25 DOD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Clinical Outcomes and Biomarkers Award (COBA) is a discretionary research grant opportunity administered by the Department of the Army through USAMRAA. It supports research intended to strengthen ALS clinical trials by developing and/or validating improved clinical outcome measures and biomarkers. 2) What is the main purpose of this award?

The purpose is to make ALS clinical trials more informative, efficient, and interpretable by improving how disease progression is measured, how patients are stratified, and how treatment response and safety are evaluated. 3) Who administers this grant opportunity? This opportunity is administered by the Department of the Army through USAMRAA.

4) What is the opportunity number? The opportunity number is HT942525ALSRPCOBA. 5) What type of funding instrument is this?

The funding instrument is a grant. 6) What is the activity category and CFDA listing? The activity category is Science and Technology and other Research and Development, and the CFDA listing provided is 12.

420. 7) Who is eligible to apply? Eligibility is listed as unrestricted.

8) What is the application deadline? The original closing date is August 27, 2025. 9) How many awards are expected to be made?

The announcement anticipates making about five awards. 10) Is there an award ceiling (maximum funding amount) listed? The award ceiling is not specified in the information provided.

11) What kinds of projects does COBA support? COBA supports projects that develop and/or validate better ALS clinical outcome measures and biomarkers, with the goal of improving the ability of clinical research and clinical trials to measure meaningful change, track progression, stratify patients, and evaluate treatment response and safety. 12) Do proposed tools need to apply to all ALS patients?

No. The announcement explicitly allows tools that are not universally applicable to every ALS patient. Projects may be tailored to a specific therapy, a class of therapeutics, or a defined ALS subtype (for example, a particular genetic mutation). 13) What focus areas must applicants address?

Applicants must address one or both of the two focus areas: (1) Clinical Biomarkers and/or (2) Clinical Outcomes. 14) What is included under Focus Area 1: Clinical Biomarkers? Clinical Biomarkers includes the identification, development, and/or validation of promising ALS biomarkers.

The solicitation is broad about biomarker types and includes susceptibility/risk, diagnostic, monitoring/disease progression, prognostic, predictive, response, and safety biomarkers. 15) What biomarker types are specifically named in the opportunity?

The opportunity includes susceptibility or risk biomarkers, diagnostic biomarkers, monitoring or disease progression biomarkers, prognostic biomarkers, predictive biomarkers, response biomarkers, and safety biomarkers. 16) What are examples of what biomarker work could enable in ALS trials?

Examples described include tools that help determine who is likely to develop ALS, support earlier or more accurate diagnosis, track progression over time with greater sensitivity than existing tools, predict clinical trajectory, identify which patients are more likely to benefit from a therapy, show whether a therapy is working, or flag adverse effects. 17) What is included under Focus Area 2: Clinical Outcomes?

Clinical Outcomes supports the identification, development, and/or validation of outcome measures for ALS studies and trials. Outcomes can be clinician-reported, observer-reported (including caregiver inputs), patient-reported outcomes, and/or performance-based measures. 18) Are improvements to existing outcome measures allowed, or only brand-new tools?

Both are allowed. The scope includes new instruments as well as refinement and optimization of outcome measures already in use, such as improving reliability, sensitivity to change, feasibility in multicenter settings, or relevance to patient priorities. 19) What is the overall intent for clinical outcome measures developed under COBA?

The intent is to produce outcome measures that more accurately reflect meaningful change in ALS and can be deployed in clinical research to evaluate interventions. 20) Are digital health measures permitted? Yes.

The opportunity permits digital health measures across both focus areas. 21) What are examples of digital health measures mentioned? Examples include wearables, smartphone sensors, video or voice recordings, imaging studies, and other devices that capture disease-relevant physiological data or functional outcomes.

22) Why does the solicitation emphasize flexibility for digital measures? It signals interest in modern measurement approaches that may provide higher-frequency data, reduce patient burden, capture real-world function, or detect subtle changes that conventional clinic-based assessments may miss. 23) Is there any special requirement for projects that enroll participants or collect biospecimens prospectively?

Yes. Projects involving prospective biospecimen collection or participant enrollment must incorporate a Community Collaboration as described in the solicitation’s Attachment 9. 24) When is Community Collaboration required?

Community Collaboration is required when an application involves prospective biospecimen collection and/or participant enrollment. 25) What does the Community Collaboration requirement imply?

It implies that proposals collecting new samples or enrolling people prospectively need a structured collaboration with the relevant community, reflecting an expectation for meaningful engagement and partnership rather than purely researcher-driven recruitment or collection. 26) Can an application address both focus areas in a single project? Yes.

Applicants must address one or both focus areas, so a single application may address Clinical Biomarkers, Clinical Outcomes, or both. 27) How does this award aim to improve ALS clinical trials?

It aims to strengthen trials by enabling better tracking of disease progression, improving patient stratification, and providing more sensitive and interpretable measures of treatment response and safety, ultimately making trial results easier to interpret and potentially reducing inefficiencies. Browse more opportunities from the same agency: Dept.

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