DoD Gulf War Illness Clinical Trial Award | Apply Online

Opportunity Summary:

The DoD Gulf War Illness Clinical Trial Award (FY15 GWIRP CTA) is a Department of the Army, USAMRAA funding opportunity under the Congressionally Directed Medical Research Programs designed to support clinical trials that can meaningfully improve the health and daily functioning of Veterans living with Gulf War Illness (GWI). This mechanism is specifically aimed at larger, more definitive trials, generally in Phase II or Phase III, and it can also support studies involving FDA-regulated medical devices across Class I through Class III. In other words, the program is looking for well-developed interventions that are ready for a rigorous test of effectiveness, rather than purely exploratory work.

A key theme of the award is tangible impact on Veteran health outcomes. The program emphasizes endpoints tied to overall functional status and real-world symptom improvement, including (but not limited to) cognitive problems, musculoskeletal issues and pain, gastrointestinal symptoms, fatigue, respiratory complaints, skin abnormalities, and sleep difficulties. The announcement also recognizes that GWI symptoms often cluster and interact, so applicants can propose trials that target a single symptom domain or evaluate how changes in one symptom complex affect others. Trials may be structured as single-site studies or multi-center efforts, depending on what is needed to answer the research question credibly and with adequate statistical power.

The FY15 GWIRP also encourages collaboration through a Multiple PI option. Applicants can apply either as a single Principal Investigator or as a coordinated team led by an Initiating PI and up to three Partnering PIs (for a maximum of four PIs total). Under this model, each PI is formally designated as a PI and receives a separate award, but all work together on one integrated clinical trial project. The Initiating PI is expected to carry most of the administrative load and should have demonstrated expertise in GWI research, while Partnering PIs can bring specialized skills from other disciplines that strengthen the trial (for example, clinical trial operations, biostatistics, device expertise, symptom-specific clinical expertise, or other relevant fields). Multidisciplinary and multi-organization teams are encouraged, and multi-site collaborations are expected to include clear communication plans and practical agreements to address intellectual property and materials issues so coordination problems do not derail the study.

The opportunity sets clear boundaries on what it will and will not fund. Applications whose primary focus is treating psychiatric conditions, including PTSD, will be administratively withdrawn, meaning they will not move forward for funding consideration under this announcement. The program also will not accept applications focused on amyotrophic lateral sclerosis (ALS) research, even though ALS rates are elevated among Gulf War Veterans. That said, studies centered on GWI symptomatology may include Gulf War Veterans who have ALS if ALS is incorporated into the study’s GWI case definition. Applicants who want to pursue ALS-focused projects are directed instead to a separate CDMRP ALS research program.

Industry involvement is explicitly welcomed. Biotechnology and pharmaceutical companies may participate as applicants (including as Single PIs, Initiating PIs, or Partnering PIs) or as collaborators. The program encourages companies to leverage their own internal resources alongside the award funding, which signals an interest in projects with realistic development pathways and the operational capacity to execute complex trials.

From an administrative standpoint, this opportunity was released as Funding Opportunity Number W81XWH-15-GWIRP-CTA. It is categorized as a discretionary research and development award and uses a cooperative agreement or grant instrument type. Eligibility is described as unrestricted (open to any type of entity), subject to any clarifications in the full announcement. The expected number of awards is listed as 1, with an estimated total funding amount of $1,500,000 and no cost sharing or matching requirement. The posting date was May 14, 2015, with an original and final closing date of October 29, 2015, and an archive date of November 28, 2015. The CFDA listing associated with the program is 12.420 (Military Medical Research and Development). For applicants needing help accessing the announcement, the contact point provided is the CDMRP Help Desk at 301-682-5507.

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