DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award

The Amyotrophic Lateral Sclerosis Pilot Clinical Trial Award is offered through the Defense Health Agency as part of the Congressionally Directed Medical Research Programs under the Amyotrophic Lateral Sclerosis Research Program. This program was established to fund high-impact research that advances treatments and improves outcomes for individuals living with ALS. Since its inception, the ALSRP has received substantial congressional appropriations and operates with a mission to accelerate the translation of scientific discoveries into effective therapies. The Pilot Clinical Trial Award specifically supports early-phase clinical trials that demonstrate strong potential to impact treatment or management of ALS. The primary purpose of this funding opportunity is to support the rapid implementation of clinical trials ranging from phase 1 through small-scale phase 2. Projects must go beyond safety assessments and evaluate therapeutic efficacy, biological effects, or clinical outcomes. Applications are required to align with one of two focus areas: biomarker-driven interventions or clinical care improvements. Biomarker-driven proposals must incorporate mechanism-specific biomarkers to assess response and biological engagement, while clinical care proposals must demonstrate near-term benefits for symptom management or patient care practices. Funding under this opportunity is substantial but limited, with approximately 5.6 million dollars allocated to support about two awards, each capped at 2.8 million dollars over a maximum performance period of three years. Funds may be used for a variety of allowable costs including clinical trial implementation, subject compensation, and collaborative travel. However, preclinical research is explicitly excluded. Projects must begin clinical trial activities within a defined timeframe after award issuance, reinforcing the program’s emphasis on readiness and rapid execution. Eligibility is broad and inclusive, allowing applications from domestic and international organizations across public and private sectors, including academic institutions, nonprofit organizations, and for-profit entities. Principal investigators must be independent researchers affiliated with eligible organizations, and there are no restrictions based on citizenship. Importantly, cost sharing is not required. Applications must include strong evidence of feasibility, access to study populations, and appropriate team expertise to conduct clinical trials successfully. The application process follows a two-step structure beginning with a required pre-application submission through the Electronic Biomedical Research Application Portal. Only applicants invited based on pre-application review may submit a full application through either eBRAP or Grants.gov depending on organizational type. Required components are extensive and include a detailed project narrative, regulatory strategy, community collaboration plan, and transition plan. Community engagement is mandatory, requiring active involvement of individuals affected by ALS or relevant organizations throughout the research process. Applications are evaluated through a rigorous two-tier review process consisting of peer review and programmatic review. Evaluation criteria include clinical impact, research strategy, feasibility, statistical rigor, recruitment plans, and ethical considerations. Additional emphasis is placed on regulatory readiness, biomarker integration where applicable, and the strength of the transition plan for future development. Projects must also demonstrate alignment with the broader mission of improving outcomes for service members, veterans, and the general population affected by ALS. Key deadlines structure the timeline, with pre-applications due in late June and full applications due at the end of September. Invitations to submit full applications are issued in early August, followed by peer and programmatic review phases later in the year. Awards are expected to be finalized by the following year, with funds obligated before the end of the federal fiscal cycle. Applicants are encouraged to begin preparations early due to the complexity of submission requirements and registration processes across multiple federal systems.

Ensure strong biomarker integration if applicable; demonstrate clinical trial readiness; include meaningful community collaboration; provide detailed regulatory and transition plans; align with ALSRP mission and impact goals