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

FAQs: DoD Amyotrophic Lateral Sclerosis Clinical Development Award (FY20 ALSRP CDA)

What is the FY20 ALSRP Clinical Development Award (CDA)?

The FY20 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Clinical Development Award (Funding Opportunity Number W81XWH-20-ALSRP-CDA) is a Department of Defense funding mechanism focused on accelerating practical, near-term progress in ALS. It emphasizes projects that directly strengthen clinical trials or improve day-to-day multidisciplinary ALS clinical care by making better use of existing human ALS data and specimens.

What is the main goal of this funding opportunity?

The goal is to move ALS research toward near-term clinical relevance by leveraging existing patient-derived resources (data and biosamples) and by supporting studies that can quickly produce outputs that enrich clinical trials, refine prognostic tools, improve patient stratification, or optimize established standards of care.

How is this award different from early-stage discovery research?

This opportunity is not centered on early-stage discovery in model systems. Instead, it prioritizes human-based ALS resources and clinical readiness, supporting studies that can directly inform clinical trials or measurably improve established multidisciplinary ALS care.

What does the program mean by "human-based ALS resources"?

"Human-based ALS resources" include existing and accessible patient-derived datasets and specimen collections, such as ongoing or completed clinical trial datasets, biorepositories with clinical specimens, large-scale molecular datasets (for example transcriptomics, proteomics, and metabolomics), structured clinical databases, and associated metadata.

Do applicants need to start with resources that already exist?

Yes. A central expectation is that the project is grounded in resources that are already available and accessible at the time the application is submitted. The program is designed to support studies that can move quickly because they rely on established collections of human ALS data and biosamples.

Is creating a brand-new patient cohort from scratch supported?

Not primarily. The mechanism is described as not designed to fund the creation of a new cohort from the ground up. The emphasis is on using existing cohorts, datasets, and biorepositories to accelerate progress without rebuilding infrastructure.

Can a project collect additional specimens or new time-point data?

Yes. The solicitation allows collection of additional specimens or data at extra time points from participants in an existing cohort. This supports longitudinal extensions and follow-up analyses, but the underlying cohort must already exist.

What does the program require regarding access and readiness of data or samples?

Applicants must clearly demonstrate 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.

Does the opportunity encourage diversity in study populations?

Yes. Applications are encouraged to incorporate diversity in their sample populations to help ensure findings generalize across different patient groups and to reduce bias that can arise from narrow or unrepresentative datasets.

What sharing expectations apply to data, results, or biosamples produced under this award?

The DoD expects broad sharing of analyses, derived results, and/or biosamples generated through supported projects. Practically, this means depositing outputs into existing publicly available curated repositories and data platforms so other researchers can validate findings, perform secondary analyses, and build on the work.

Where should awardees deposit data and other outputs?

The solicitation points applicants to a list of suitable ALS resources hosted on the ALSRP website. Other repositories or platforms may also be used if they are appropriate and supported by a letter of support that addresses repository parameters and broad access.

What is the purpose of a repository letter of support?

If using a repository or platform (including those beyond the referenced ALSRP list), a letter of support should describe key repository parameters and explain how broad access to resulting data and samples will be enabled. This supports the program goal of maximizing downstream use and impact.

What types of projects are a good fit for this CDA?

The opportunity highlights studies that (1) use patient-based resources to define ALS subtypes, predict therapeutic response, or improve prognostic assessment; (2) correlate clinical trial-related biosamples, imaging, or epidemiological measures with clinical outcomes; (3) add companion aims to an anticipated or ongoing clinical trial when those aims are not otherwise supported by the trial; and (4) optimize components of established multidisciplinary ALS care.

How can this award help with ALS heterogeneity in clinical trials?

By supporting projects that better define ALS subtypes and improve prediction of therapeutic response or prognosis, the award aims to strengthen stratification and interpretation in clinical trials and to improve clinical decision-making in care settings.

What does "companion aims" mean in the context of this solicitation?

Companion aims are add-on objectives that attach to an anticipated or ongoing clinical trial but are not otherwise supported by that trial. The intent is to increase what the broader trial can learn without recreating trial infrastructure or disrupting the primary trial design.

What areas of clinical care improvement does the award specifically mention?

The solicitation mentions optimizing elements of established multidisciplinary ALS 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.

Which agency administers this opportunity?

This is a discretionary DoD opportunity administered under the U.S. Army Medical Research Acquisition Activity (USAMRAA).

What award instruments may be used?

Awards may be made as grants or cooperative agreements.

What is the CFDA number for this opportunity?

The CFDA listing is 12.420.

Who is eligible to apply?

Eligibility is described as unrestricted (open to any entity type), subject to any additional eligibility clarifications in the full announcement.

How many awards are anticipated?

The opportunity anticipates around three awards.

Is there a maximum award amount (ceiling) listed?

The posting lists an award ceiling of 0. This typically indicates 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.

What is the overall emphasis of the program design?

The program is designed to push ALS research toward near-term clinical relevance by requiring strong access to existing human resources, expecting open deposition and broad sharing of outputs, and prioritizing projects that either sharpen clinical trials or measurably improve current standards of ALS care.