DoD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award | W81XWH 22 ALSRP PCTA

Opportunity Information: Apply for W81XWH 22 ALSRP PCTA

The DoD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award (FY22) is designed to move ALS research into the clinic quickly by funding early, tightly focused human studies that can meaningfully shape what happens next. The core goal is rapid implementation of a clinical trial that can materially improve how future, larger trials are designed and run, rather than proving that a therapy is ready for broad use by the end of the award. Supported studies can range from phase 1 through small, phase 2 style trials, with an emphasis on generating practical, decision-making evidence about safety, feasibility, early signals of efficacy, and biomarker performance in ALS-relevant patient populations. The program also allows trials that target specific ALS subpopulations, and in some cases potentially even highly individualized approaches, as long as the outcomes clearly help de-risk and accelerate subsequent development.

To be eligible under this mechanism, the proposed work must be a clinical trial as defined by federal standards: a research study in which one or more human participants are prospectively assigned to one or more interventions (including placebo or other control conditions) to evaluate effects on biomedical or behavioral health-related outcomes. This award is not meant for preclinical projects; investigators who are still at the laboratory stage are directed to other ALSRP announcements. The intervention in a therapeutic trial can be a drug, biologic, or device, but it needs to be supported by a strong scientific rationale and existing preclinical or other prior evidence that justifies testing in people. The program is structured around the idea that the most valuable early trials are the ones that reduce uncertainty for the field by clarifying what to test, in whom, and how.

A major distinguishing requirement is the heavy emphasis on biomarkers for therapeutic trials. Applicants proposing a therapeutic intervention are expected to include a biomarker-driven plan that generates compelling biomarker data, because predictive, prognostic, and pharmacodynamic biomarkers are viewed as essential tools for better patient selection, stronger trial efficiency, and clearer interpretation of outcomes. Biomarker work may include target engagement measures (evidence the therapy is hitting the intended target), pharmacodynamic measures (evidence the therapy produces a biological effect), and predictive or cohort-selective biomarkers (evidence that a subgroup is more likely to respond). The program explicitly frames biomarker integration as a way to de-risk later-stage trials, not as an optional add-on.

The award also includes a Clinical Care Tier for applicants who are not testing a new therapeutic, but instead want to run a clinical trial aimed at improving established ALS care. These projects must be proposed under a lower total direct cost cap than therapeutic trials and can include, for example, optimizing respiratory care strategies, improving approved devices and assistive technologies, or testing symptom management strategies. For this tier, reviewers place particular weight on near-term, real-world impact on patient care.

Operational readiness is another central theme. The program expects funded trials to start quickly: no later than 12 months after the award date, or up to 18 months for FDA-regulated studies. Preliminary data relevant to the proposed trial are required, and applications must demonstrate that the needed patient population is available and accessible, with a credible enrollment and accrual plan. Applicants must also describe how they will include women and minorities in a manner appropriate to the trial objectives, reflecting expectations around representative participation and thoughtful recruitment planning.

Applications are expected to show practical feasibility on the intervention side as well. Investigators must document that they have access to the drug, compound, device, or other intervention materials for the duration of the study. The proposal must also demonstrate that the team and environment are capable of running a compliant clinical trial, including experience with trial operations, statistics, data management, and (when relevant) FDA processes. The opportunity highlights the importance of having a study coordinator to shepherd the protocol through the Institutional Review Board (IRB) and any additional regulatory approvals, coordinate activities across sites, and manage participant enrollment. Where FDA regulation applies, the institution may need to commit to serving as the FDA regulatory sponsor and taking on sponsor responsibilities described in 21 CFR 312.

On the methods side, strong trial design expectations are spelled out. Applicants must present clearly defined objectives, appropriate endpoints and outcome measures, and alignment with Good Clinical Practice (GCP). A clear statistical analysis plan is required, including power and sample size justification tied to the study objectives, plus a data management plan that protects data integrity. For FDA-regulated trials, the data systems must be compliant with 21 CFR Part 11 and use appropriate data standards. Proposals must also include a safety management plan describing pharmacovigilance and safety oversight (as applicable), and a clinical monitoring plan describing how the study will be monitored for GCP compliance.

The program also requires applicants to think beyond the pilot trial itself. A Transition Plan is expected, explaining how the intervention or care optimization approach will move forward after the award, including what the next trial phase would be and what funding or resources could support that next step. Impact is evaluated in terms of how directly the trial results will inform later development: for therapeutics, whether outcomes will substantially de-risk and guide later-phase trial design; for clinical care optimization, whether outcomes can produce near-term benefits for people living with ALS.

From an administrative standpoint, this FY22 opportunity was offered by the Department of Defense (Department of the Army, USAMRAA) under Funding Opportunity Number W81XWH-22-ALSRP-PCTA, with funding instruments listed as grants and cooperative agreements. Eligibility is described as unrestricted (open to any entity type unless further limited in the full announcement). The posting indicates an estimated three awards. The original posting date was March 16, 2022, with an original closing date of July 28, 2022. Budget requests must be well-justified and aligned to the proposed scope, with additional restrictions referenced in the full funding instructions. Finally, funded trials must comply with federal human subjects requirements, including posting the informed consent form on a publicly available federal website as required under 32 CFR 219.

• 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, Pilot Clinical Trial 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 Mar 16, 2022.
• Applicants must submit their applications by Jul 28, 2022. (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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