DoW Peer Reviewed Medical, Clinical Trial Award

The Peer Reviewed Medical Research Program Clinical Trial Award is administered by the Defense Health Agency through the Congressionally Directed Medical Research Programs, which was established by the U.S. Congress to support high-impact medical research relevant to military health. Since its inception, the program has invested billions in advancing scientific discoveries that directly benefit Service Members, Veterans, and their families. This specific funding opportunity is designed to accelerate clinical research that can quickly translate into improved treatments, interventions, or clinical practices for conditions aligned with congressionally directed topic areas and strategic goals. The primary purpose of this award is to support the rapid implementation and execution of clinical trials that evaluate the safety, efficacy, or effectiveness of interventions in human participants. The program emphasizes research that can produce near-term clinical impact and transform patient care. Applicants must propose studies that meet the formal definition of a clinical trial, involving human participants prospectively assigned to interventions with measurable health outcomes. Preclinical research and animal studies are explicitly excluded, and all preparatory laboratory work must be completed prior to the start of the award. Funding is structured across three tiers corresponding to the scale and phase of the clinical trial. These range from smaller early-phase or proof-of-concept trials to large-scale phase 3 trials involving more than 300 participants. Applicants may also include an optional planning phase of up to 12 months, which supports regulatory approvals and trial readiness activities. Total funding caps vary by level, with clinical trial budgets reaching up to 20 million dollars, and planning phases capped at 800,000 dollars. The maximum performance period is four years for the trial phase, with an additional year allowed for planning if applicable. Eligibility is broad and inclusive, allowing both domestic and international organizations, including public and private entities, for-profit and nonprofit institutions, and government organizations. Independent investigators affiliated with eligible organizations may serve as Principal Investigators. There are no citizenship restrictions, and cost sharing is not required. However, each investigator may only serve as the Principal Investigator on one application within this program cycle. The application process follows a two-step submission model. Applicants must first submit a pre-application through the electronic Biomedical Research Application Portal, which includes a narrative, budget estimate, and supporting documentation. Selected applicants are then invited to submit a full application through Grants.gov or eBRAP depending on organizational type. The full application requires extensive documentation, including a detailed project narrative, study design, regulatory strategy, recruitment plan, and multiple supporting attachments. Applications are evaluated through a rigorous multi-tier review process. Initial screening assesses alignment with program priorities, scientific merit, and feasibility. Full applications undergo peer review focused on clinical impact, research strategy, feasibility, recruitment plans, regulatory readiness, and ethical considerations. Programmatic review then determines final funding recommendations based on portfolio balance and relevance to military health needs. Key deadlines include a pre-application submission deadline in late July and a full application deadline in late September, with peer review occurring later in the year and funding decisions expected the following spring. Awards are anticipated to be issued by the end of the following fiscal year. The program is offered annually, reflecting its recurring nature and ongoing commitment to advancing clinical research with meaningful real-world impact.

Focus on demonstrating clinical impact and readiness; ensure regulatory approvals or strategy are strong; align clearly with topic areas and strategic goals; provide robust study design and recruitment feasibility