DoW Traumatic Brain Injury and Psychological Health, Clinical Trial Award

The Traumatic Brain Injury and Psychological Health Clinical Trial Award is administered by the Defense Health Agency through the Congressionally Directed Medical Research Programs. This funding opportunity is part of a broader federal initiative to improve prevention, diagnosis, and treatment of traumatic brain injury and psychological health conditions affecting service members, veterans, and the general public. The program originates from congressional appropriations and reflects ongoing federal investment in addressing the long-term impacts of brain injury and mental health challenges, particularly those associated with military service. The primary purpose of this award mechanism is to support clinical trials that have the potential to produce meaningful and actionable outcomes in the treatment or management of traumatic brain injury and psychological health conditions. Funded projects must be clinical trials and may evaluate a wide range of interventions including drugs, biologics, medical devices, diagnostics, therapies, or behavioral health strategies. Applicants are required to include preliminary data and must incorporate community-based participatory research approaches to ensure engagement with affected populations. The program offers two research levels, one focused on early-stage or pilot clinical trials and another on larger-scale, advanced trials evaluating effectiveness in patient populations. Funding is structured with defined cost caps based on the selected research level. Research Level 1 supports smaller or early-phase trials with a total funding limit, while Research Level 2 supports larger and more advanced trials with a higher funding ceiling. The total program funding is expected to support a limited number of awards, and the maximum performance period for any awarded project is four years. Funds may be used for a wide range of allowable costs including personnel, travel for dissemination, participant support, and data sharing activities, though certain restrictions apply such as prohibitions on tuition costs and limits on travel expenditures. Eligibility for this opportunity is broad and inclusive, allowing applications from both domestic and international organizations across public and private sectors, including for-profit and nonprofit entities. Principal Investigators must be independent researchers affiliated with an eligible organization. There is also a specific partnering option that encourages collaboration with early-career investigators, allowing two principal investigators to share responsibility and funding. Cost sharing is not required for this program, lowering barriers to participation for eligible applicants. The application process is a two-step submission requiring an initial pre-application followed by an invited full application. Pre-applications must be submitted through the designated portal and include a concise narrative outlining the study rationale, aims, and design. Only applicants who receive an invitation may proceed to submit a full application, which includes detailed project documentation such as a project narrative, study design, statistical plan, regulatory strategy, and multiple supporting attachments. The submission process requires registration across federal systems and adherence to strict formatting and content guidelines. Applications are evaluated through a multi-tiered review process beginning with pre-application screening, followed by peer review and programmatic review for full applications. Review criteria emphasize scientific rigor, feasibility, clinical impact, recruitment strategy, regulatory readiness, and alignment with program priorities. Additional considerations include ethical protections, data sharing plans, and the strength of the research team. Final funding decisions are based on both scientific merit and programmatic relevance, with awards expected to be announced following the review cycle. Key deadlines include a pre-application submission in mid-July and a full application deadline in mid-October, with peer and programmatic reviews occurring later in the year and early the following year. Awards are anticipated to be made by the end of the fiscal cycle, and funded projects are expected to begin within a defined timeframe after award issuance. The program is expected to recur annually based on congressional appropriations, making it an ongoing opportunity for researchers in this field. Additional support resources and contact information are provided through the program’s administrative portals to assist applicants throughout the submission process.

Prioritize strong clinical impact and feasibility; ensure inclusion of preliminary data; clearly demonstrate access to study population and intervention; integrate community-based participatory research meaningfully; align with focus areas and military health relevance