DoD Multiple Sclerosis, Clinical Trial Award | HT942524MSRPCTA

Opportunity Information: Apply for HT942524MSRPCTA

The DoD Multiple Sclerosis Research Program (MSRP) Clinical Trial Award (CTA) is a Department of Defense grant opportunity designed to accelerate the launch and execution of clinical trials that could meaningfully improve the treatment or day-to-day management of multiple sclerosis. The program is geared toward studies that can move quickly into the clinic and generate actionable results, whether that means testing a promising therapeutic idea for the first time in people or running a more developed trial to estimate safety and early signs of benefit. Trials supported under this mechanism can evaluate a wide range of interventions and strategies, including drugs and biologics, medical devices, clinical guidance approaches, and newer technologies or methods that may change how MS is treated or monitored.

A central feature of this opportunity is that applicants must choose one of two funding levels, and only one level can be selected per application. The funding level should match the maturity and scope of the proposed trial, and the budget must be tightly justified based on what the trial is realistically designed to accomplish. Funding Level 1 (CTA-FL1) is intended for smaller, early-phase, proof-of-principle studies, such as pilot work, feasibility trials, first-in-human efforts, or phase 0 style studies. These projects are meant to show whether an approach is workable in practice or to generate the information needed to design a larger, more definitive trial. Funding Level 2 (CTA-FL2) supports larger phase 1 or phase 2 clinical trials aimed at generating preliminary evidence of safety and/or efficacy, including effects on clinical outcomes (how patients feel or function) or paraclinical outcomes (for example, imaging or biomarker-based measures). For Level 2 projects, the program expects a stronger, more detailed justification for design choices such as the intervention, trial length, sample size, endpoints, measurement tools, and assessment schedule.

This award mechanism places heavy emphasis on readiness to execute. Preliminary data are required for both funding levels, and the expectation is that the data are directly relevant to the proposed trial, ideally coming from studies in people with MS. The trial must also be able to start quickly after award: the clinical trial is expected to begin within 12 months of the award date, or within 18 months if the study is regulated by a Regulatory Agency (defined here as the U.S. Food and Drug Administration or an applicable international regulator). In practice, this means applicants need to show they have done enough groundwork, such as protocol development and operational planning, to avoid long delays after funding.

Applications must also demonstrate that the study can actually enroll the right participants. Reviewers will look for evidence of access to an appropriate MS patient population and a credible recruitment and accrual plan that can hit enrollment targets. The application should explain how enrollment goals will be met and include an inclusion strategy for women and minorities that fits the scientific aims of the trial. An exception is noted for certain studies using human biospecimens or datasets that cannot be linked back to identifiable individuals or demographic attributes and are typically exempt from IRB review; those studies are exempt from the demographic inclusion strategy requirement as described.

Because the mechanism supports interventional clinical research, applicants are expected to address intervention availability, risk, and safety management in a concrete way. The proposal should document that the drug, compound, device, or other required materials will be available for the full duration of the study. It must clearly describe anticipated risks, including potential safety issues and adverse events, and lay out steps to minimize risk to participants and staff or manage risks that cannot be eliminated. A key operational requirement is an emergency care plan for study-related injuries, including clarity on who pays for treatment if an adverse event occurs as a result of trial participation.

The award also prioritizes proven clinical trial capability and infrastructure. Applications are expected to show that the research team has the expertise to run a clinical trial end-to-end, including appropriate statistical skills, data handling capabilities, and familiarity with FDA processes when applicable. The program specifically calls for inclusion of study coordinator support to shepherd the protocol through the local IRB of record and any other regulatory approvals, coordinate activities across participating sites, and manage participant accrual. Strong institutional support is expected, and if the project requires an FDA regulatory sponsor, the application should show a commitment and capacity to fulfill sponsor responsibilities under 21 CFR 312, Subpart D.

Finally, applicants must provide a rigorous statistical analysis and data management approach. The proposal should include a clear statistical analysis plan and a power analysis that justifies the sample size and demonstrates that the trial can answer its stated objectives. A data management plan is also required, including use of an appropriate database to protect data integrity and security. If a Regulatory Agency requires it, the trial must use a database compliant with 21 CFR Part 11 and follow appropriate data standards, reflecting the expectation that data will be managed at a level suitable for regulatory review and high-confidence interpretation.

Administrative details from the notice include: the funding opportunity title is "DoD Multiple Sclerosis, Clinical Trial Award" (opportunity number HT942524MSRPCTA), offered as a discretionary grant through the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA). Eligibility is listed as unrestricted, the CFDA number is 12.420, and the original closing date is October 7, 2024. The notice anticipates making about three awards, underscoring that this is a competitive mechanism focused on well-justified, trial-ready proposals with a realistic path to near-term clinical impact.

• 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 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 2024-04-19.
• Applicants must submit their applications by 2024-10-07. (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.

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