DOD Duchenne Muscular Dystrophy, Clinical/Translational Research Award | HT942524DMDRPCTRA

Opportunity Information: Apply for HT942524DMDRPCTRA

The FY24 Department of Defense Duchenne Muscular Dystrophy Research Program (DMDRP) Clinical/Translational Research Award (CTRA) is a grant mechanism designed to push promising Duchenne muscular dystrophy (DMD) projects closer to real-world clinical use. The program is focused on advanced translational work, meaning studies that deliberately connect applied or preclinical science with clinical observations in a two-way, iterative way. The expectation is not a simple bench-to-bedside pipeline, but a research plan where clinical findings shape laboratory and applied work, and those results then feed back into clinical research decisions. Because the goal is near-term clinical impact, applications are expected to be grounded in preliminary and/or published DMD-relevant data rather than early concept-stage ideas.

This opportunity is meant for projects that have already moved beyond basic discovery and proof-of-concept and are ready for the kinds of translational steps that can change clinical research practice or influence patient care in the nearer term. The solicitation explicitly welcomes studies that can support development of drugs, devices, and other interventions, including correlative and supportive studies that improve how therapies are designed, evaluated, or targeted. Pilot and proof-of-principle clinical trials are allowed, as are other human-centered studies that strengthen the evidence base needed to advance interventions. A notable priority area is work aimed at therapies that could be effective across the lifespan and disease stages, including very young children (infants and toddlers) as well as non-ambulatory individuals, which signals a desire for approaches that remain relevant beyond the early ambulatory phase that has traditionally dominated many DMD trial designs.

A key feature of the FY24 CTRA is the Early-Career Partnering PI Option, which is meant to expand capacity in the DMD research community through meaningful collaboration. Under this structure, one investigator serves as the Initiating PI and manages most submission and administrative responsibilities, while an early-career investigator serves as the Partnering PI and is expected to contribute substantially to the science and execution of the project. If funded, each PI is listed on a separate award to their organization(s), with separate reporting and compliance responsibilities. The intent is to encourage real shared leadership and not just nominal mentoring arrangements.

Applicants must choose one of two funding levels, selecting the category that matches the size and complexity of the proposed work. Funding Level 1 supports smaller, less complex preclinical and/or clinical research efforts (including pilot clinical trials) with total direct costs not to exceed $650,000 over the full period of performance. Funding Level 2 supports larger, more complex preclinical and/or clinical research efforts (also including pilot clinical trials) with total direct costs not to exceed $1.35 million over the full period of performance. The Early-Career Partnering PI Option is available under either level without changing these maximum direct cost caps.

The solicitation also clarifies how it distinguishes a clinical trial from broader clinical research. A clinical trial, consistent with 45 CFR 46.102, involves prospectively assigning human subjects to one or more interventions (including placebo or controls) to evaluate the effects on biomedical or behavioral health-related outcomes. Studies that do not evaluate an intervention for safety, effectiveness, or efficacy are not treated as clinical trials under this definition. In contrast, clinical research is described as observational or non-interventional research involving human data, specimens, and/or interaction with human subjects, such as studies of disease mechanisms in humans, biomarker or imaging development, diagnostic/detection research, health disparity studies, technology development, epidemiology, behavioral studies, and outcomes/health services research, as long as they are not assessing an intervention in the way a clinical trial does. The opportunity also notes an exclusion: certain in vitro studies using human data/specimens that cannot be linked to a living individual and that qualify for exemption under the Common Rule are not included in its definition of clinical research for these purposes.

From an administrative standpoint, this is a discretionary DoD grant under CFDA 12.420, offered by the Department of the Army (USAMRAA). Eligibility is listed as unrestricted. The opportunity number is HT942524DMDRPCTRA. The posted original closing date is August 22, 2024, and the program anticipated making around three awards. Applicants conducting clinical research are encouraged to consult guidance from the Muscular Dystrophy Coordinating Committee (MDCC) on strategies to promote diversity in muscular dystrophy research participation, reflecting an emphasis on improving representation and inclusivity in human-subjects research where feasible and appropriate.

• 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 Duchenne Muscular Dystrophy, Clinical/Translational Research 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 2024-05-07.
• Applicants must submit their applications by 2024-08-22. (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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