Opportunity Information: Apply for HT942526ALSRPCOBA
The FY26 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Clinical Outcomes and Biomarkers Award (COBA) is a Department of the Army (USAMRAA) discretionary grant opportunity designed to strengthen ALS clinical trials by improving the tools used to measure disease and treatment effects. The program is focused on research that develops and/or validates clinical outcomes and biomarkers that can make trials more informative, efficient, and better targeted. Importantly, proposed projects do not need to apply to every person with ALS; they may be tailored to a specific therapy, a class of therapies, or a defined ALS subgroup, including particular genetic forms of ALS.
A central aim of this award is to advance clinical biomarkers that can be used in real-world trials and studies. This includes work to identify, develop, and validate biomarkers across a wide range of uses, such as susceptibility or risk biomarkers (helping identify who might be more likely to develop ALS), diagnostic biomarkers (supporting earlier or more accurate diagnosis), monitoring or disease progression biomarkers (tracking how ALS changes over time), prognostic biomarkers (helping predict likely disease course), predictive biomarkers (helping determine who is more likely to benefit from a given therapy), response biomarkers (showing whether a treatment is having an effect), and safety biomarkers (helping detect or predict adverse effects). The common thread is practical clinical trial enrichment: the biomarker should help answer clinically meaningful questions or improve the design and interpretability of ALS trials.
The award also supports development and validation of clinical outcome measures, meaning the ways ALS is assessed in studies beyond traditional lab measures. This can include clinician-reported outcomes, observer-reported outcomes (for example, caregiver observations), patient-reported outcomes, and performance outcomes that quantify functional abilities. The scope explicitly allows applicants to improve and refine existing outcome measures already used in ALS research, which signals that the program values both innovation and pragmatic optimization of tools that could be adopted relatively quickly by the ALS research and clinical trial community.
A distinctive feature of this funding opportunity is openness to digital health measures and technology-enabled assessment methods. Applications may incorporate wearables, smartphone sensors, video or voice recordings, imaging studies, or other devices that capture physiologic signals or disease-relevant functional outcomes. This makes the program well-suited to approaches that aim to collect more frequent, objective, or real-world data, potentially reducing reliance on infrequent clinic visits and increasing sensitivity to change over time.
Another key expectation is meaningful community collaboration. Applicants are expected to explain how the ALS lived experience community informed the research question and/or the study design. In practice, this emphasizes patient-centered research: outcomes and biomarkers should align with what matters to people living with ALS and their families, and study procedures should reflect feasibility and acceptability in real-life settings. This requirement also suggests reviewers will look for credible engagement plans rather than superficial consultation.
Administratively, the opportunity is listed as HT942526ALSRPCOBA under CFDA 12.420, with an unrestricted eligibility category. It is offered as a grant under the Science and Technology and other Research and Development activity category. The posting was created on 2026-05-04, with an original closing date of 2026-09-30. The forecast indicates an expected 7 awards, and the award ceiling is not specified in the provided details.Apply for HT942526ALSRPCOBA
- The Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoW Amyotrophic Lateral Sclerosis Research Program, 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 2026-05-04.
- Applicants must submit their applications by 2026-09-30. (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 7 candidate(s).
- Eligible applicants include: Unrestricted.
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FY26 ALSRP Clinical Outcomes and Biomarkers Award (COBA) - FAQs
What is the FY26 ALSRP Clinical Outcomes and Biomarkers Award (COBA)?
The FY26 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Clinical Outcomes and Biomarkers Award (COBA) is a Department of the Army (USAMRAA) discretionary grant opportunity intended to strengthen ALS clinical trials by improving the tools used to measure disease status and treatment effects.
What is the main purpose of this award?
The main purpose is to develop and/or validate clinical outcomes and biomarkers that make ALS trials more informative, more efficient, and better targeted. The emphasis is on practical tools that improve trial design and interpretability.
Who is offering this funding opportunity?
The opportunity is offered by the Department of the Army through the U.S. Army Medical Research Acquisition Activity (USAMRAA).
What kinds of research does COBA support?
COBA supports research focused on developing and/or validating (1) clinical biomarkers and (2) clinical outcome measures that can be used in real-world ALS trials and studies to better measure disease and treatment effects.
Do projects have to apply to all people with ALS?
No. Proposed projects do not need to apply to every person with ALS. They may be tailored to a specific therapy, a class of therapies, or a defined ALS subgroup, including particular genetic forms of ALS.
What types of biomarkers are within scope for this award?
The award supports identifying, developing, and validating biomarkers intended for clinical trial enrichment, including:
- Susceptibility or risk biomarkers
- Diagnostic biomarkers
- Monitoring or disease progression biomarkers
- Prognostic biomarkers
- Predictive biomarkers
- Response biomarkers
- Safety biomarkers
What is meant by "clinical trial enrichment" in this opportunity?
In this context, clinical trial enrichment means the biomarker or outcome measure should be practically useful for improving the design, targeting, and interpretability of ALS clinical trials. The tool should help answer clinically meaningful questions or improve how treatment effects are detected and understood.
Does the program focus only on discovering new biomarkers?
No. The program emphasizes developing and/or validating biomarkers for real-world trials and studies, which can include identification as well as development and validation steps, as long as the goal is practical use in ALS trials.
What are "clinical outcome measures" under this award?
Clinical outcome measures are ways ALS is assessed in studies beyond traditional lab measures. COBA supports developing and validating these measures so trials can better capture how ALS affects people and how treatments may change disease impact over time.
What kinds of clinical outcome measures are eligible?
The scope includes multiple categories of outcomes, such as:
- Clinician-reported outcomes
- Observer-reported outcomes (for example, caregiver observations)
- Patient-reported outcomes
- Performance outcomes that quantify functional abilities
Can applicants improve existing ALS outcome measures rather than create entirely new ones?
Yes. The opportunity explicitly allows applicants to improve and refine existing outcome measures already used in ALS research, supporting both innovation and pragmatic optimization for quicker adoption by the ALS research and clinical trial community.
Are digital health measures and technology-enabled assessments allowed?
Yes. A distinctive feature of this opportunity is that it is open to digital health measures and technology-enabled assessment methods.
What are examples of technology-enabled approaches that may be included?
Applications may incorporate tools such as wearables, smartphone sensors, video or voice recordings, imaging studies, or other devices that capture physiologic signals or disease-relevant functional outcomes.
Why does the opportunity emphasize digital measures?
Digital and technology-enabled measures can help capture more frequent, objective, or real-world data. This may reduce reliance on infrequent clinic visits and increase sensitivity to change over time in trials and studies.
Is collaboration with the ALS community required?
There is an expectation of meaningful community collaboration. Applicants are expected to explain how the ALS lived experience community informed the research question and/or the study design.
What does "meaningful community collaboration" imply for applicants?
It implies patient-centered research: the biomarkers and outcomes should align with what matters to people living with ALS and their families, and study procedures should reflect feasibility and acceptability in real-life settings. Reviewers are likely to look for credible engagement plans rather than superficial consultation.
What is the opportunity number or listing identifier?
The opportunity is listed as HT942526ALSRPCOBA.
What is the CFDA number for this program?
The CFDA number provided is 12.420.
What is the eligibility for this opportunity?
The eligibility category is listed as unrestricted.
What is the funding instrument and activity category?
It is offered as a grant under the Science and Technology and other Research and Development activity category.
When was this opportunity posted?
The posting was created on 2026-05-04.
What is the application deadline?
The original closing date is 2026-09-30.
How many awards are expected to be made?
The forecast indicates an expected 7 awards.
Is there an award ceiling (maximum award amount)?
The award ceiling is not specified in the provided details.
Does the opportunity prioritize biomarkers, clinical outcomes, or both?
Both. The opportunity is designed to strengthen ALS clinical trials by improving tools used to measure disease and treatment effects, and it supports both clinical biomarkers and clinical outcome measures.
Can a project focus on a biomarker or outcome that is relevant only to certain therapies or subgroups?
Yes. Projects may be targeted to a specific therapy, a class of therapies, or a defined ALS subgroup, including particular genetic forms of ALS.
What is the unifying theme across the different biomarker types listed?
The unifying theme is practical clinical trial usefulness: the biomarker should support clinically meaningful questions or improve trial design and interpretability (for example, better targeting of participants, better monitoring, clearer evidence of response, or improved safety assessment).
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