DOD Amyotrophic Lateral Sclerosis, Clinical Outcomes and Biomarkers Award | HT942524ALSRPCOBA

Opportunity Information: Apply for HT942524ALSRPCOBA

The FY24 DOD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Clinical Outcomes and Biomarkers Award (COBA) is a Department of the Army (USAMRAA) grant opportunity designed to strengthen ALS clinical trials by improving the tools used to measure whether a therapy is working and for whom it is most likely to work. The core purpose is to support projects that develop and/or validate clinical outcomes and biomarkers that can make trials more informative, more efficient, and more likely to succeed. Importantly, proposed work does not have to be broadly applicable to every person with ALS; it can be tailored to a specific investigational therapy, a class of therapeutics, or a defined ALS subgroup, including genetically defined subtypes.

The types of research encouraged under this award span a wide range of trial-enabling measures. On the biomarker side, this includes target engagement biomarkers that show a drug is interacting with its intended biological target, as well as objective pharmacodynamic biomarkers that capture the biological effect of a therapy in the body. The opportunity also emphasizes predictive or cohort-selective biomarkers, meaning markers that help identify which individual patients or subgroups are most likely to benefit from a particular therapy, which is critical for smarter enrollment strategies and for reducing noise in trial results. Beyond treatment response, the program is interested in diagnostic, prognostic, and disease progression biomarkers that can improve confidence in identifying ALS, forecasting disease course, and measuring progression over time with greater precision.

On the clinical outcomes side, COBA supports efforts to validate outcome measures used in trials, including clinician-reported, observer-reported, patient-reported, and performance-based outcomes. The aim is to ensure that trial endpoints are rigorous, meaningful, and sensitive enough to detect change. The program also explicitly encourages work that defines ALS subtypes using patient-based resources, linking biospecimens and/or digital data elements to high-quality molecular and clinical data. In practical terms, this means projects can focus on connecting biological signatures (for example, omics profiles or imaging patterns) with clinical trajectories, functional measures, or therapy responses, ultimately helping the field move toward better stratification and more personalized trial design.

Another major theme is leveraging and strengthening existing datasets and infrastructure rather than building everything from scratch. Applicants are encouraged to use well-characterized, highly curated clinical resources such as ongoing or completed clinical trial datasets, biorepositories, registries, large omics datasets, patient-reported outcomes collections, digital biomarker datasets (including wearable or remote monitoring data), and clinical databases with usable metadata. The funding announcement gives concrete examples, including the CDC National ALS Registry and Biorepository, and points applicants to an ALSRP resource list for additional suitable repositories. Projects may also propose other resources as long as they clearly describe how the repository is structured and how broad access is enabled, which signals that data quality, governance, and reusability matter for competitiveness.

The award also highlights the relevance of military-connected populations. Applicants are expected to consider active-duty military and/or Veteran patient populations or resources where feasible, aligning with the Department of Defense focus and encouraging studies that may illuminate ALS in these communities or ensure they are represented in the evidence base.

Administratively, this is a discretionary grant (Funding Opportunity Number HT942524ALSRPCOBA; CFDA 12.420) under the Department of the Army, USAMRAA. Eligibility is listed as unrestricted, meaning a wide range of applicant organizations may apply. The original closing date for the FY24 opportunity was July 10, 2024. The announcement indicates an expected number of awards of five, with the award ceiling not specified in the provided text. Overall, the program is geared toward practical, trial-facing deliverables: validated biomarkers and outcome measures, better subtype definitions, and improved strategies for measuring ALS progression, including projects that augment or correlate biospecimens, imaging, and digital health data with clinical outcomes within the context of clinical trials.

• 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 2024-03-25.
• Applicants must submit their applications by 2024-07-10. (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.

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