DOD Toxic Exposures, Clinical Trial Award | W81XWH 22 TERP CTA

Opportunity Information: Apply for W81XWH 22 TERP CTA

The DOD Toxic Exposures, Clinical Trial Award (FY22 TERP CTA; Funding Opportunity Number W81XWH 22 TERP CTA) is a Department of Defense research funding opportunity designed specifically to accelerate the launch and execution of clinical trials focused on health problems linked to toxic exposures. The central purpose is practical and near-term impact: funded studies are expected to generate results that meaningfully improve prevention strategies, treatments, or symptom management for diseases and conditions that arise from, or are associated with, toxic exposures. This is not a mechanism for exploratory laboratory work; it is built to move candidate interventions forward in human testing with an eye toward real-world medical use.

A key requirement is program alignment. Any proposed trial must clearly address at least one FY22 TERP Programmatic Goal and at least one FY22 TERP Topic Area. In other words, it is not enough to propose a well-designed trial in the general area of toxic exposures; the work must match the specific priorities defined by the Toxic Exposures Research Program for that fiscal year. This alignment functions as a gatekeeper for relevance and ensures the funded projects contribute to the program's targeted objectives rather than broadly framed environmental or occupational health questions.

The award supports a wide range of clinical trial stages and sizes, from small early efforts to larger definitive studies. On the early end, the opportunity allows for proof-of-concept trials such as pilot studies, first-in-human trials, or phase 0 trials aimed at demonstrating feasibility, establishing preliminary signals, refining endpoints, and generating data that can inform the design of subsequent phase trials. On the later end, applicants may propose larger-scale trials intended to test efficacy in relevant patient populations. This flexibility allows applicants to enter at the stage that best fits the maturity of their intervention and the readiness of the evidence base to justify human testing.

In terms of what can be tested, the program is broadly open to different intervention types as long as they are evaluated through a clinical trial framework. Trials may assess new or repurposed products, pharmacologic agents including drugs and biologics, medical devices, clinical guidance or care pathways, and emerging approaches or technologies. The emphasis is on interventions that are promising and actionable, not merely descriptive or observational. The intent is that funded outcomes contribute to a structured clinical development pathway, ideally positioning the research to support FDA clearance or approval for devices or drugs when applicable, and/or to support the development or strengthening of clinical practice guidelines where regulatory approval is not the primary endpoint.

This opportunity has a strict boundary around what it will and will not fund: applications must include a clinical trial and cannot be used for animal studies or preclinical research. If the proposed work is not a clinical trial, the application is subject to withdrawal. That makes the mechanism particularly suited to teams that already have sufficient preclinical or preliminary human data to justify a trial, have an intervention ready for implementation in a clinical research setting, and can execute quickly.

Administratively, the opportunity is offered by the Department of Defense, Department of the Army, through USAMRAA, and is categorized under Science and Technology and other Research and Development (CFDA 12.420). The funding instruments include both grants and cooperative agreements, meaning that depending on the award type, there may be varying levels of government involvement in the project. Eligibility is listed as unrestricted, indicating that it is generally open to a broad range of applicant organizations, subject to any additional eligibility clarifications in the full announcement. For FY22, the posting anticipated making about three awards. The listing shows an award ceiling of 0, which typically indicates that a specific maximum was not captured in the summary field and would need to be confirmed in the full solicitation documents. The original posting date was September 21, 2022, with an original closing date of December 1, 2022.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DOD Toxic Exposures, Clinical Trial Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Sep 21, 2022.
• Applicants must submit their applications by Dec 01, 2022. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 3 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

Apply for W81XWH 22 TERP CTA

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