DoD Multiple Sclerosis, Clinical Trial Award | HT9425 23 MSRP CTA

Opportunity Information: Apply for HT9425 23 MSRP CTA

The DoD Multiple Sclerosis, Clinical Trial Award (MSRP CTA; Funding Opportunity Number HT9425-23-MSRP-CTA) is a Department of Defense funding opportunity administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA) to move multiple sclerosis (MS) clinical research into the clinic quickly. The core purpose is to support the rapid launch and execution of clinical trials that could meaningfully improve the treatment or management of MS. The program is broadly interested in trials that evaluate promising therapeutic or management options, including new products, drugs or biologics, devices, clinical guidance, and emerging approaches or technologies. Projects can span the spectrum from smaller proof-of-concept efforts (such as pilot studies, first-in-human work, or phase 0-type feasibility studies) to larger trials designed to determine whether an intervention works in a relevant patient population.

A defining feature of this award is that it is strictly a clinical trial mechanism: the funds must support an actual clinical trial rather than preclinical or purely observational work. Applicants choose one of two funding levels, and only one level can be selected per application. The program emphasizes that the requested budget must be well-justified and match the proposed trial scope, with the funding level selection left to the applicant based on what the trial is designed to accomplish. While the posted notice does not state an award ceiling (it lists an award ceiling of 0 in the summary record), the solicitation itself sets the practical limits through the two defined funding levels and associated restrictions referenced in the full announcement.

Funding Level 1 is meant for small-scale, early-phase, proof-of-principle clinical trials. These studies are generally intended to demonstrate feasibility, de-risk an approach, or generate critical information that shapes the design of a later, more definitive trial. This could include limited pilot testing of an intervention, early safety/feasibility signals, and operational demonstration that recruitment, procedures, and assessments can be carried out as planned. Importantly, the CTA requires preliminary data for Funding Level 1, so applicants are expected to bring some credible prior evidence that supports moving into a clinical trial rather than proposing an idea from scratch.

Funding Level 2 supports larger phase 1 or phase 2 trials that aim to produce preliminary evidence of safety or efficacy, including measurable benefit on clinical outcomes (how patients feel or function) or paraclinical outcomes (biomarkers, imaging, or other objective measures that are relevant to MS). Because these studies are larger and more resource-intensive, the announcement stresses the need for strong justification of the design choices. That justification may cover the intervention type, expected duration, sample size and enrollment assumptions, outcome measures and assessment tools, and how often participants will be assessed. Preliminary data are also required for Funding Level 2, reflecting the program expectation that these trials should be grounded in prior evidence and positioned to generate interpretable, decision-grade results.

The opportunity also sets several practical readiness requirements meant to ensure that funded projects can start quickly and run credibly. The clinical trial is expected to begin no later than six months after the award date, which pushes applicants to have protocols, logistics, and regulatory pathways largely planned in advance. Applications must show that an appropriate study population is available and accessible, and they must explain how accrual targets will be met. Relatedly, applicants need to describe an inclusion strategy for women and minorities that matches the objectives of the study, signaling that enrollment planning and representativeness are not optional add-ons but part of the expected trial design.

Applicants must also document intervention availability for the full intended study period. In practice, this means demonstrating access to the drug/compound, device, or other necessary materials in a way that is realistic for the trial timeline and scale. On the operations side, the DoD is looking for a team and environment that are already capable of conducting a regulated clinical trial, including appropriate statistical expertise, trial operations experience, data management capacity, and (when relevant) knowledge of FDA processes. The announcement explicitly calls for a study coordinator function to shepherd the protocol through the local IRB of record and any other required federal regulatory approvals, coordinate multi-site activities if more than one site is involved, and manage participant accrual logistics.

Regulatory expectations are framed around the term "Regulatory Agency," which in this solicitation refers to the U.S. Food and Drug Administration or an applicable international regulator, depending on where and how the trial is being conducted. The application should reflect institutional support and, when applicable, a commitment to serve as the FDA regulatory sponsor. That includes taking on sponsor responsibilities described in 21 CFR 312 (including Subpart D), which is particularly relevant for investigational drugs and biologics and signals that the DoD expects applicants to be prepared for real-world regulatory compliance, not just scientific execution.

Finally, the program places strong emphasis on rigor in statistics and data handling. Applications are expected to include a clear statistical analysis plan, a power analysis that justifies sample size and demonstrates the trial can answer its primary objectives, and a data management plan that protects data integrity using an appropriate database. If a regulatory agency requires it, the trial must use a 21 CFR Part 11-compliant database and appropriate data standards, reinforcing that the data should be credible and auditable for regulatory-grade decision-making.

Administrative details from the listing include that this is a discretionary opportunity offered as a grant or cooperative agreement under CFDA 12.420, with eligibility listed as unrestricted (open to any entity type unless the full announcement provides additional constraints). The posting lists an expected three awards, with an original closing date of October 6, 2023, and a creation date of April 14, 2023. Overall, the CTA is best understood as a readiness-and-impact-driven MS clinical trial program: it prioritizes well-supported interventions, realistic recruitment and operational plans, fast start-up, and regulatory-quality trial conduct aimed at producing results that can meaningfully shape MS 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 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 14, 2023.
• Applicants must submit their applications by Oct 06, 2023. (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 HT9425 23 MSRP CTA

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: