US Dept of Defense – Toxic Exposures Research Program

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Investigator-Initiated research Award – HT9425-23-TERP-IIRA

up to USD$500,000 over 3 years
Letters of Intent due 13 September 2023
Supports studies that will make an important contribution toward research and/or patient care for a disease or condition related to military-related toxic exposures
projects may focus on any phase of research from basic laboratory research through translational research, including preclinical studies in animal models and human subjects, as well as correlative studies associated with an existing clinical trial. New Approach Methodologies may also be used.
Collaboration with military and/or Department of Veterans Affairs (VA) researchers and clinicians is encouraged
research involving human subjects and human anatomical substances is permitted
clinical trials not allowed
preliminary data required
must address at least 1 Program Goal and at least 1 Topic Area

Translational Research Award – HT9425-23-TERP-TRA

up to USD$800,000 over 3 years OR up to USD$1.6M over 3 years (Partnering PI option)
Letters of Intent due 13 September 2023
Supports translational research that will accelerate the movement of promising ideas in military-related toxic exposure research into clinical applications including health care products, interventions, technologies, and/or clinical practice guidelines
Participation of at least one military or Veteran consumer as a member of the research team is strongly encouraged.
Collaboration with military and/or VA researchers and clinicians is encouraged.
research involving human subjects and human anatomical substances is permitted
clinical trials not allowed
preliminary data required
must address at least 1 Program Goal and at least 1 Topic Area

Clinical Trial Award – HT9425-23-TERP-CTA

up to USD$1.5M over 4 years OR up to USD$2.5M over 4 years (Partnering PI option)
Letters of Intent due 13 September 2023
Supports the rapid implementation of clinical trials with the potential to have a significant impact on the prevention, treatment, or management of symptoms, diseases, or conditions associated with or resulting from military-related toxic exposures.
Proposed projects may range from small proof-of-concept clinical trials (eg pilot, first-in-human, phase 0) to demonstrate feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.
Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies.
Participation of at least one military or Veteran consumer as a member of the research team is strongly encouraged.
Collaboration with military and/or VA researchers and clinicians is encouraged.
Inclusion of at least one clinician on the study team is strongly encouraged.
preclinical studies (including animal studies) not allowed
preliminary data required
must address at least 1 Program Goal and at least 1 Topic Area

Toxic Exposures RP Program Goals

Elucidate mechanisms of how military-related toxic exposures result in adverse effects, including but not limited to toxicities, malignancies, neurologic and respiratory disorders, cardiac complications, sleep disorders, immune system dysfunction, gastrointestinal issues, etc
Diagnose the effects of military-related toxic exposures, understand the phenotypic, pathological, and clinical outcomes associated with short-term and long-term exposures, and predict disease progression
Predict and prevent military-related toxic exposures by identifying strategies that can anticipate, identify, monitor, and prevent Service Members and the American public from adverse effects of exposures to toxic substances.
Develop therapeutics, treatments, and strategies to minimize symptoms and disease progression associated with military-related toxic exposures.

Toxic Exposures RP Topic Areas

Neurotoxin exposure
Gulf War Illness and its treatment
Airborne hazards and burn pits
Other military service-related toxic exposures in general, including prophylactic medications, pesticides, organophosphates, toxic industrial chemicals, materials, metals and minerals

Documents

Funding Opportunity – Clinical Trial Award: HT9425-23-TERP-CTA