DoD Gulf War Illness Treatment Evaluation Award | Apply Online

Opportunity Information: Apply for W81XWH 16 GWIRP TEA

The DoD Gulf War Illness Treatment Evaluation Award is a grant opportunity focused on evaluating treatments for Gulf War Illness (GWI) through early phase clinical trials, specifically Phase 0, I, or I/II. The program aims to significantly improve the health and well-being of Veterans affected by GWI, targeting outcomes like functional status and symptom management, including cognitive function, pain, fatigue, and sleep difficulties.

Applicants can choose between two tracks for their proposals:

1. **Data-Based Treatment Track**: This track is for interventions with substantial preliminary data from GWI models or biological insights from Veterans. It may involve pharmacologic or physiological treatments and requires documented preliminary support.

2. **Symptom-Based Treatment Track**: This track allows for innovative treatments that have been previously studied for other conditions but not in GWI. Preliminary data is not necessary, but a solid scientific rationale is required, ideally backed by peer-reviewed literature.

Key submission aspects include:

- Trials should start within six months of award receipt. - A comprehensive statistical analysis plan, including a power analysis, must be provided. - Documentation of drug or material availability, adhering to FDA standards, is essential. - Experience with FDA processes is encouraged. - Applicants must have access to a suitable population of Gulf War Veterans, with collaboration recommended with VA investigators. - A study coordinator is essential for managing regulatory processes and participant recruitment. - A transition plan for advancing the treatment post-award should be included. - Strong institutional support is necessary, along with clearly defined study endpoints. - Compliance with Good Clinical Practice (GCP) guidelines must be outlined. - A detailed monitoring, data management, and safety management plan is required. - Commitment to register the study on the NIH clinical trials registry is essential.

Collaboration with industry partners in biotechnology or pharmaceuticals is encouraged to enhance funding resources. However, studies focused solely on psychiatric conditions like PTSD will not be funded under this grant.

• The DOD-AMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Gulf War Illness Treatment Evaluation 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 May 13, 2016 and posted on May 13, 2016.
• Applicants must submit their applications by Oct 20, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2025.)
• The number of recipients for this funding is limited to 4 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 16 GWIRP TEA

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