DoD Amyotrophic Lateral Sclerosis Clinical Development Award | W81XWH 20 ALSRP CDA

Opportunity Information: Apply for W81XWH 20 ALSRP CDA

The DoD Amyotrophic Lateral Sclerosis Clinical Development Award (FY20 ALSRP CDA; Funding Opportunity Number W81XWH-20-ALSRP-CDA) is a Department of Defense research funding mechanism meant to speed practical progress in ALS by making stronger use of existing human ALS data and specimens and by improving elements of day-to-day clinical care. Rather than focusing on early-stage discovery in model systems, this opportunity centers on projects that can directly enrich clinical trials or refine established multidisciplinary ALS care. The DoD position in this call is that meaningful gains can come from leveraging well-characterized patient-derived resources that already exist, or by partnering with ongoing clinical research so that new analyses or companion objectives can be added efficiently without recreating infrastructure from scratch.

A key feature of this program is its emphasis on "human-based ALS resources." In this context, that includes ongoing or completed clinical trial datasets, biorepositories containing clinical specimens, and large-scale molecular datasets such as transcriptomics, proteomics, or metabolomics, as well as structured clinical databases and associated metadata. The central expectation is that applicants will start with resources that are already available and accessible at the time the application is submitted. In other words, this mechanism is not primarily designed to fund the creation of a new cohort from the ground up; instead, it supports studies that can move quickly because they are grounded in established collections of patient data and biosamples.

The solicitation also places a strong requirement on access and readiness. Applicants must clearly demonstrate that they can obtain and use the specific datasets, samples, or platforms needed to carry out the proposed aims, and that these resources are in hand (or otherwise fully accessible) when the proposal is submitted. The program does allow collection of additional specimens or data at extra time points from participants in an existing cohort, which supports longitudinal extensions and follow-up analyses, but the underlying cohort must already exist. Applications are also encouraged to incorporate diversity in their sample populations, reflecting a broader push for findings that generalize across different patient groups and reduce bias that can arise when datasets are narrow or unrepresentative.

Another major requirement is broad sharing of outputs. The DoD expects that analyses, derived results, and/or biosamples generated through supported projects should be made widely available to the research community. Practically, this means depositing data into existing publicly available curated repositories and data platforms, so that other investigators can validate findings, perform secondary analyses, and build on the work. The solicitation points applicants to a list of suitable ALS resources hosted on the ALSRP website, while still allowing other resources as long as an appropriate letter of support is provided. That letter should describe key repository parameters and, importantly, explain how broad access to resulting data and samples will be enabled, reinforcing the program's goal of maximizing downstream use and impact.

In terms of what kinds of studies fit, the opportunity highlights several categories. One is the use of patient-based resources to better define ALS subtypes, predict therapeutic response, or improve prognostic assessment, which aligns with the need to handle ALS heterogeneity in clinical trials and care. Another is correlating clinical trial-related biosamples, imaging, or epidemiological measures with clinical outcomes, which can strengthen biomarkers, stratification strategies, or mechanistic interpretation of trial results. The program also welcomes companion aims that attach to an anticipated or ongoing clinical trial but are not otherwise supported by the trial itself, essentially enabling add-on objectives that can increase what the broader trial learns without disrupting the primary trial design. Finally, it supports studies focused on optimizing components of established ALS multidisciplinary clinical care, including approaches to respiratory care, evaluation or use of approved devices, and targeted symptom management strategies, with the intent of improving real-world patient management alongside therapeutic development.

Administratively, this is a discretionary DoD opportunity under the U.S. Army Medical Research Acquisition Activity (USAMRAA), and awards may be made as grants or cooperative agreements. The CFDA listing is 12.420, eligibility is described as unrestricted (open to any entity type, subject to any additional eligibility clarifications in the full announcement), and the opportunity anticipated around three awards. The posting lists an award ceiling of 0, which typically signals that applicants should refer to the full funding announcement for budget limits or that limits may depend on scope and negotiation rather than a single fixed cap in the summary record. Overall, the program is designed to push ALS research toward near-term clinical relevance by combining strong access to existing human resources, clear plans for open deposition of outputs, and projects that either sharpen clinical trials or measurably improve current standards of ALS care.

• The Department of Defense, 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 Development 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 Jan 17, 2020.
• Applicants must submit their applications by Jul 23, 2020. (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 3 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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