DoW Toxic Exposures Clinical Trial Award

The Clinical Trial Award under the Toxic Exposures Research Program is administered by the Defense Health Agency through the Congressionally Directed Medical Research Programs. The program originates from congressional appropriations beginning in 2022 and is designed to address the health impacts of military-related toxic exposures affecting Service Members, Veterans, their families, and the general public. The funding opportunity is part of a broader federal effort to improve prevention, diagnosis, and treatment of diseases and conditions linked to environmental and occupational hazards encountered in military contexts. The primary purpose of this award is to support the advancement, execution, and analysis of clinical trials that demonstrate strong potential for meaningful clinical impact. Eligible studies may range from early-stage proof-of-concept trials to large-scale trials evaluating efficacy in patient populations. The program emphasizes translational outcomes, including progression toward regulatory approval or the development of clinical practice guidelines. Projects must align with at least one program goal such as predicting and preventing exposure effects, improving diagnosis, or advancing treatment strategies, and must also address one of several designated topic areas including neurotoxin exposure, Gulf War Illness, airborne hazards, or other service-related toxic exposures. Funding for this opportunity is limited, with approximately one award anticipated at a total cost cap of 4.5 million dollars and a maximum period of performance of four years. The funding mechanism is a grant, and funds must be used strictly to support clinical trials; preclinical or animal research is explicitly prohibited. Allowable costs include subject compensation, collaboration travel, and dissemination activities, while restrictions apply to certain travel and non-clinical research expenses. Cost sharing is not required. Eligibility is broad and includes both domestic and international organizations across public, private, nonprofit, and for-profit sectors, including federal entities. Applications must be submitted by independent investigators affiliated with eligible organizations. A unique feature of the program is the optional Partnering Principal Investigator structure, which allows two investigators to collaborate and receive separate awards to enhance interdisciplinary research. Individuals in training positions are not eligible to serve as principal investigators. The application process follows a two-step structure beginning with a required pre-application submitted through the eBRAP system. Selected applicants are then invited to submit a full application through either Grants.gov or eBRAP depending on organizational type. Required application components include a detailed project narrative, supporting documentation, study design, regulatory strategy, recruitment and safety plans, and multiple abstracts. Applications must clearly demonstrate feasibility, access to study populations, regulatory readiness, and a strong scientific rationale supported by preliminary data. Applications are evaluated through a multi-tiered review process consisting of peer review and programmatic review. Evaluation criteria include clinical impact, scientific merit, feasibility, recruitment strategy, regulatory planning, statistical analysis, and overall study management. The program places strong emphasis on military relevance, patient impact, and the potential to improve quality of life. Successful applicants are expected to begin clinical trials within 12 months of award and meet regulatory submission requirements where applicable. Key deadlines for this funding opportunity include a pre-application deadline of August 19, 2026, and a full application deadline of November 19, 2026. Invitations to submit full applications are expected in early October 2026, with peer review occurring in January 2027 and programmatic review in March 2027. Awards are anticipated to be made by September 30, 2027. Applicants are encouraged to prepare early due to required registrations and the complexity of submission requirements.

Strong preliminary data and clear clinical impact are critical; demonstrate feasibility with access to study populations; align explicitly with program goals and topic areas; ensure regulatory readiness early