DoD Multiple Sclerosis, Clinical Trial Award | W81XWH 22 MSRP CTA

Opportunity Information: Apply for W81XWH 22 MSRP CTA

The Department of Defense (DoD) Multiple Sclerosis Research Program (MSRP) Clinical Trial Award (CTA) is a funding opportunity intended to move multiple sclerosis (MS) clinical research quickly into real-world testing, with an emphasis on trials that could meaningfully change how MS is treated or managed. The core purpose is rapid implementation of clinical trials that have a clear path to patient impact, whether that means improving symptoms, slowing progression, refining disease management strategies, or generating the evidence needed to justify a larger, definitive trial.

This opportunity supports a broad range of clinical trial concepts as long as they are focused on MS and are positioned to produce actionable results. Applicants can propose trials evaluating new products, pharmacologic agents (including drugs and biologics), medical devices, clinical guidance approaches (such as care pathways or management strategies), and emerging technologies. The program is flexible on trial size and maturity, allowing everything from smaller proof-of-concept efforts (such as pilot studies, first-in-human work, or other early stage clinical evaluations) up through larger trials designed to determine efficacy in relevant patient populations. In practical terms, the DoD is signaling that it will consider both early feasibility testing and more structured phase 1 or phase 2 trials, as long as the study design matches the funding level selected and the project is positioned to produce impactful evidence.

A key structural feature of the FY22 CTA is that it offers two funding levels, and an applicant must choose only one level per application. The selection is left to the applicant, but the budget requested must be tightly justified and clearly aligned with the size, complexity, and needs of the proposed trial. Both funding levels require preliminary data that are relevant to the proposed clinical trial, meaning applicants are expected to have some foundational evidence already in hand (for example, prior clinical observations, feasibility metrics, strong preclinical rationale, or early human data, depending on the intervention and stage). The preliminary data requirement is important because it underscores that the award is meant to accelerate execution of trials that are ready to move, not to fund exploratory concepts without supporting evidence.

Funding Level 1 (FL1) is geared toward smaller-scale, early-phase, proof-of-principle trials. These studies are typically designed to demonstrate feasibility (for example, recruitment and retention capability, adherence, tolerability, operational practicality, or the ability to collect specific outcome measures), or to generate the information needed to design a more advanced trial (such as estimating effect size, refining endpoints, selecting assessment schedules, or testing procedures). FL1 can also cover other clinical trials that fit within a smaller and earlier scope, but the common theme is that the work should reduce uncertainty and set up the next step toward broader testing. Preliminary data are required for FL1, reinforcing that even pilot or early feasibility trials need a strong rationale and evidence base.

Funding Level 2 (FL2) supports larger-scale phase 1 or phase 2 clinical trials aimed at generating preliminary evidence of safety or efficacy in MS patient populations. The program expects a strong justification for the proposed design choices, and it calls out several elements that should be well defended: the type of intervention, the duration of the trial, the sample size, the outcome measures (clinical and/or paraclinical), the assessment tools, and how often assessments will occur. This reflects an expectation that FL2 trials are more formally constructed, with design features that can credibly support an early read on benefit and risk, and that can inform go/no-go decisions for later-phase development. Like FL1, FL2 requires preliminary data relevant to the proposed trial.

From an administrative standpoint, the opportunity is listed as W81XWH 22 MSRP CTA and is administered by the Department of Defense, Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA). The funding instrument type includes cooperative agreements and grants, and the activity category is science and technology research and development (CFDA 12.420). Eligibility is described as unrestricted, meaning it is broadly open to different entity types, subject to any additional clarifications in the full announcement. The posting indicates an expected number of awards of three. The notice shows an award ceiling of 0, which typically means the public listing does not specify a single fixed maximum in that field and applicants need to rely on the detailed funding level restrictions and budget guidance in the full announcement. The opportunity was created on April 29, 2022, with an original closing date of October 3, 2022.

Overall, this CTA is designed for teams that are ready to run a clinical trial in MS now, not later, and can justify why the proposed intervention, trial design, and endpoints are likely to produce meaningful results. The two-tier structure lets applicants align the request with where they are in development: FL1 for focused feasibility or proof-of-principle work that sets up the next trial, and FL2 for more substantial phase 1 or phase 2 studies seeking early evidence of safety and/or clinical benefit in people with MS.

• 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 Multiple Sclerosis, 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 Apr 29, 2022.
• Applicants must submit their applications by Oct 03, 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.

Apply for W81XWH 22 MSRP CTA

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