DoD Multiple Sclerosis Clinical Trial Award

The Multiple Sclerosis Research Program Clinical Trial Award is a federal funding opportunity administered through the Defense Health Agency Contracting Activity and managed by the Congressionally Directed Medical Research Programs under the Defense Health Agency Research and Development office. The program was established to support research with high scientific merit and significant clinical impact related to multiple sclerosis. The overall vision of the program is to prevent, cure, reverse, or slow the progression of multiple sclerosis while reducing its personal and societal burden for Service Members, Veterans, their Families, and the broader public. The funding opportunity specifically supports the rapid implementation and execution of clinical trials that have the potential to improve the treatment or management of multiple sclerosis. Applications must address at least one designated focus area tied to neuroprotection, remyelination, symptom treatment, or related therapeutic strategies. The opportunity provides two funding levels designed to support different phases and scales of clinical trial development. Funding Level 1 supports smaller-scale proof-of-principle clinical trials such as pilot studies, first-in-human studies, and phase 0 trials intended to demonstrate feasibility or inform future advanced trials. Funding Level 2 supports larger phase 1 or phase 2 clinical trials intended to generate preliminary evidence of safety or efficacy in relevant patient populations. Preliminary data relevant to the proposed clinical trial are required for both levels, with Funding Level 2 specifically requiring data relevant to multiple sclerosis populations. The total cost cap for Funding Level 1 applications is $1,000,000 with a maximum period of performance of three years, while Funding Level 2 applications may request up to $2,000,000 with a maximum performance period of four years. Approximately two Funding Level 1 awards and one Funding Level 2 award are anticipated from roughly $4 million in available program funding. The funding opportunity supports only clinical trial activities and explicitly excludes preclinical research. Clinical trials may evaluate drugs, biologics, devices, rehabilitation methods, behavioral interventions, neuroprosthetics, lifestyle strategies, or emerging therapeutic technologies. Applications are required to address one or both designated focus areas. The first focus area emphasizes promoting repair, neuroprotection, and remyelination in multiple sclerosis through interventions designed to restore neurological function or reduce degeneration. The second focus area supports studies focused on treating multiple sclerosis symptoms including fatigue, pain, depression, impaired mobility, cognitive dysfunction, and other clinically significant impairments. The program specifically excludes projects focused solely on developmental myelination, basic demyelination mechanisms, or peripheral immunomodulatory strategies that only secondarily affect tissue injury. Applicants are encouraged to include strong statistical analysis plans, robust recruitment strategies, rigorous safety monitoring procedures, and multidisciplinary collaborations involving academia, industry, federal agencies, military institutions, or the Department of Veterans Affairs. Eligible applicants include both extramural and intramural organizations, including domestic and foreign entities, nonprofit organizations, for-profit organizations, public entities, and private institutions. Independent investigators at all career levels may serve as Principal Investigators if affiliated with an eligible organization. Each investigator may only serve as Principal Investigator on one application under this funding opportunity. Cost sharing is not required. Applications must demonstrate access to the study population, intervention availability, and adequate infrastructure to conduct the proposed trial. If a proposed study requires an Investigational New Drug application, Investigational Device Exemption, or equivalent regulatory filing, the regulatory submission must be submitted to the appropriate regulatory agency before the full application deadline. The proposed clinical trial must begin within 12 months of the award date, or within 18 months for studies requiring regulatory oversight. The submission process includes both a required pre-application and a full application. The pre-application consists of a one-page Letter of Intent submitted through the Electronic Biomedical Research Application Portal. Full applications are submitted either through Grants.gov for extramural applicants or through eBRAP for intramural Department of War organizations. The full application package includes numerous required components such as a Project Narrative, Supporting Documentation, Technical Abstract, Lay Abstract, Statement of Work, Study Population Recruitment and Safety Plan, Regulatory Strategy, Study Personnel and Organization documentation, Post-Award Transition Plan, Impact Statement, and budget-related forms. The Project Narrative is limited to 20 pages and must comprehensively describe the intervention, study design, objectives, statistical analysis plan, recruitment strategies, and mitigation approaches. Supporting documentation includes references, letters of support, research sharing plans, questionnaires, and documentation of regulatory interactions. Applications undergo a two-tier review process involving peer review and programmatic review. Applications are evaluated according to several major review criteria including clinical impact, research strategy and feasibility, recruitment and retention plans, regulatory strategy, transition planning, statistical rigor, ethical considerations, personnel qualifications, and communication plans. Clinical impact and research strategy are considered the most important scored criteria. Reviewers assess whether the intervention addresses unmet clinical needs, improves current standards of care, and demonstrates sufficient scientific rationale and feasibility. Applications must also demonstrate appropriate plans for enrollment diversity, statistical power, informed consent, risk management, and dissemination of results. Programmatic review additionally considers portfolio balance, alignment with fiscal year priorities, and relevance to designated focus areas. The highest-scoring applications are not automatically funded because final recommendations consider both scientific merit and broader programmatic priorities. The pre-application deadline is July 30, 2026, and the full application deadline is August 13, 2026. The application verification period closes on August 20, 2026. Peer review is scheduled for December 2026, followed by programmatic review in February 2027. Awards are expected to be issued no later than September 30, 2027. Applicants are advised to begin registrations for SAM.gov, Grants.gov, and eBRAP well in advance because activation may require several weeks. Questions related to submission requirements and technical assistance may be directed to the eBRAP Help Desk at help@eBRAP.org or 301-682-5507, while Grants.gov registration support is available at support@grants.gov or 800-518-4726. The program announcement emphasizes strict compliance with submission requirements, eligibility rules, and formatting standards because noncompliant applications may be administratively rejected or withdrawn.

Demonstrate strong clinical impact and alignment with one or both designated focus areas. Provide clear evidence of access to patient populations and interventions. Include rigorous statistical power analysis and detailed recruitment mitigation strategies. Ensure IND or IDE submissions are completed before the application deadline when applicable. Clearly explain feasibility, safety monitoring, and transition planning for future clinical implementation.