DoD Toxic Exposures Clinical Trial Partnership Award

The Department of Defense (DOD) Fiscal Year 2025 Toxic Exposures Research Program (TERP) Clinical Trial Partnership Award (CTPA) is administered through the Congressionally Directed Medical Research Programs (CDMRP). This opportunity is managed by the U.S. Army Medical Research and Development Command (USAMRDC) under the U.S. Army Medical Research Acquisition Activity (USAMRAA). TERP was established in fiscal year 2022 with the mission to support impactful research focused on understanding, diagnosing, and treating adverse health outcomes from military-related toxic exposures. In FY25, the program received a $15 million appropriation, with a portion allocated for this specific award. The goal of the FY25 TERP CTPA is to support new or existing collaborative partnerships conducting clinical trials that significantly impact prevention, diagnosis, treatment, or management of health conditions stemming from military-related toxic exposures. Projects may include proof-of-concept trials, phase 0 studies, or larger pragmatic trials targeting specific interventions, such as drugs, biologics, devices, or clinical practices. The trials are expected to advance toward FDA approval or lead to the establishment of new clinical guidelines. Projects must address at least one of the five program goals and one of four topic areas, including neurotoxin exposure, Gulf War illness and its treatment, airborne hazards and burn pits, or other military service-related toxic exposures. The program explicitly excludes studies on classified data, non-traditional chemical warfare agents, and acute care countermeasures. Eligible applicants include both extramural and intramural organizations, including for-profit and nonprofit entities, academic institutions, and foreign or domestic public or private institutions. Independent investigators at all career levels are eligible, but postdoctoral and mentored positions do not qualify as independent. Applications must involve a collaboration between an Initiating Principal Investigator (PI) and up to two Partnering PIs. Each PI must make a unique and substantial contribution to the proposed overarching study. Submissions must include evidence of collaboration and shared scientific and administrative responsibilities. The award provides up to $4.2 million in total costs over a four-year period. Only one award is expected. Funds must support a clinical trial and cannot be used for preclinical or animal research. Costs may include travel for collaborative meetings, compensation for research subjects, and project dissemination expenses. Prohibited costs include travel beyond the stated limits and any preclinical work. Subawards and indirect costs must be managed per each organization’s negotiated rate agreements. The application process requires submission of a pre-application by July 29, 2025, through eBRAP. Full application invitations will be issued by September 4, 2025, with final submissions due by October 16, 2025, through Grants.gov or eBRAP depending on the organization type. Review stages include peer review in December 2025 and programmatic review in February 2026, with awards issued no later than September 30, 2026. The application must include a comprehensive project narrative, regulatory strategy, recruitment and safety plans, impact statements, and a detailed post-award transition plan. Rigorous study design, involvement of clinicians and military/Veteran consumers, and adherence to data sharing requirements are emphasized. Contact points for application support include the eBRAP Help Desk ([email protected]) and the Grants.gov Contact Center ([email protected]).

Preliminary data is required Collaborations must be clearly defined and documented Military or Veteran population recruitment is strongly encouraged Review TERP goals and topic areas in detail before application Justify all aspects of study design and ethical considerations