DoD Gulf War Illness Innovative Treatment Evaluation Award | Apply Online

Opportunity Summary:

The DoD Gulf War Illness Innovative Treatment Evaluation Award (ITEA) is a FY2009 funding opportunity under the Gulf War Illness Research Program (GWIRP) run by the Department of the Army/USAMRAA. Its purpose is to support early, systematic testing of promising treatments for Gulf War Illness (GWI) in Gulf War veterans, with an emphasis on improving health and functional status. This mechanism was introduced for the first time in FY09 and is positioned as a stepping stone: it funds smaller, earlier clinical evaluations intended to generate results that can justify and shape later, larger efficacy trials.

A central feature of the ITEA is that it is meant for innovative interventions that have not previously been studied in ill Gulf War veterans. Innovation here does not necessarily mean a brand-new therapy; it can include treatments already used in routine clinical practice or tested in related chronic multisymptom conditions (for example fibromyalgia or chronic fatigue syndrome) as long as the application is clearly focused on Gulf War Illness. The program is open to a broad range of treatment approaches, including pharmacologic therapies, other physiological interventions, complementary and integrative approaches, or combinations of these, as long as the proposal is a clinical trial involving an intervention.

In terms of study type, ITEA is designed for smaller, early-phase or pilot trials, typically Phase II or Phase I/II, and it explicitly does not require preliminary data. Applicants may include preliminary data if they have it, and it does not have to come specifically from prior GWI studies. However, if an intervention already has substantial preliminary and preclinical evidence suggesting it is well developed for GWI and ready for a definitive test, the program indicates that such a proposal is a better fit for the separate GWIRP Clinical Trial Award (CTA), which supports larger, more definitive Phase II or Phase III trials. Another important boundary is that ITEA funds cannot be used for preclinical work or for trials focused only on pharmacokinetics/pharmacodynamics or safety (for example Phase 0 or Phase I-only studies).

The announcement allows flexibility in trial design, recognizing that early evaluation can be done through several prospective methods depending on the treatment, feasibility, and existing evidence. Acceptable examples mentioned include systematic case series, prospective outcome evaluation studies, small-scale randomized trials, or other innovative prospective designs. Regardless of the approach, proposals are expected to define clear, focused health outcome endpoints. These endpoints may be clinical (symptom reduction), functional (improved day-to-day functioning), or objective measures (clinical or laboratory markers) when appropriate. Applicants must also clearly define how GWI cases will be identified for enrollment, including any targeted subgroup definitions, and must lay out a credible plan for accessing Gulf War veteran participants, meeting accrual targets, and ensuring the needed clinical resources are in place.

Regulatory and startup expectations are spelled out in practical terms. If the intervention requires an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE), the program expects those submissions to be made or completed before applying, and it warns that if IND/IDE approval is not obtained within six months after the award date, the government may revoke funding. The award also assumes the intervention will be available in sufficient quantity when the award is made and that the clinical trial will begin within 12 months of the award date. The application is built primarily around a study protocol, and while local IRB submission or approval is not required at the time of application, the protocol must ultimately be reviewed and approved by the PI’s IRB, USAMRMC, and any other required regulatory bodies before the study can start.

The opportunity also lists clear exclusions and redirections. Studies whose main focus is treatment of psychiatric conditions are not eligible under this announcement. Proposals focused on amyotrophic lateral sclerosis (ALS) are also not accepted here, since ALS research was being handled through a separate DoD program in FY09. Additionally, retrospective or non-interventional designs are not considered clinical trials for this purpose and are directed instead to a different GWIRP mechanism (the Investigator-Initiated Research Award).

From an administrative standpoint, this is a discretionary funding opportunity offered as grants and cooperative agreements under CFDA 12.420 (Military Medical Research and Development). The opportunity number is W81XWH-09-GWIRP-ITEA. It anticipated around 4 awards with an estimated total funding level of $2,880,000, had no cost sharing requirement, and was posted April 21, 2009 with a closing date of September 9, 2009 (archived October 9, 2009). Eligibility was listed as unrestricted, meaning a wide range of applicant organizations could apply so long as they met any conditions in the full announcement.

In plain terms, the ITEA was built to help researchers move a credible, scientifically grounded treatment idea into a real-world test in Gulf War veterans, even if the idea is early and does not yet have GWI-specific preliminary data. The program wants proposals that are truly focused on GWI, are feasible to start quickly, are designed to produce interpretable health outcomes, and are positioned to inform later, larger trials if results are promising.

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