Gulf War Illness, Clinical Trial Award | W81XWH 18 GWIRP CTA

Opportunity Information: Apply for W81XWH 18 GWIRP CTA

The FY18 Gulf War Illness Research Program (GWIRP) Clinical Trial Award is a Department of Defense funding opportunity aimed at quickly launching clinical trials that could make a meaningful difference for Veterans affected by Gulf War Illness (GWI). The program is designed to move promising interventions into real-world testing without unnecessary delay, with a clear emphasis on trials that can lead to improved health and day-to-day functioning for Veterans. Rather than focusing on basic or exploratory lab science, this award is specifically about clinical evaluation in people, with outcomes that matter clinically and functionally.

This opportunity supports a wide range of clinical trials, from smaller early-stage efforts to larger, more definitive studies. Applicants may propose small proof-of-concept projects such as pilot studies, first-in-human work, or Phase 0-style trials that are meant to test feasibility, refine protocols, or generate key information needed to design a subsequent larger trial. At the other end of the spectrum, the award can also support large-scale clinical trials intended to determine efficacy in GWI Veteran populations. The core idea is to fund trials that are ready to be implemented and that have a plausible path to producing actionable results for GWI care.

The types of interventions that can be tested are broad. Trials may evaluate new products, pharmacologic agents including drugs or biologics, medical devices, clinical guidance approaches, and emerging technologies or treatment strategies. The outcomes of interest are also broad, reflecting the multisystem nature of GWI. The solicitation highlights improvements in overall functional status as well as changes in symptom complexes commonly seen in GWI, including cognitive problems, musculoskeletal and pain symptoms, gastrointestinal issues, fatigue, respiratory problems, skin abnormalities, sleep difficulties, and other related symptom patterns. In other words, proposals are expected to target outcomes that directly align with the lived symptom burden and functional limitations experienced by Veterans.

The program draws an important distinction between early-stage innovation and later-stage confirmation. For early phase or pilot trials that represent an initial evaluation of a treatment or intervention, the award places special value on innovation and does not require preliminary data. Innovation can mean testing something entirely new for GWI, but it can also mean taking an intervention that has been used in other chronic multisymptom illnesses and evaluating it for the first time specifically in Veterans with GWI. For larger and more definitive clinical trials, including those that expand on earlier promising pilot results, the expectations are higher: these applications must include preliminary data related to safety in a GWI Veteran population. That requirement reflects the increased responsibility that comes with scaling up to broader testing and potentially wider clinical impact.

Budgeting is expected to match what is being proposed. The requested funds should be appropriate for the trial phase and the size and complexity of the study, with additional limits and rules described in the opportunitys funding restrictions section. The award mechanism listed for this opportunity includes both grants and cooperative agreements, meaning that depending on the specific award structure, there may be varying levels of involvement or oversight by the funding agency during execution.

A notable feature introduced in FY18 is an optional Biorepository Contribution component tied to a newly established Gulf War Illness biorepository network. In FY17, the program funded infrastructure for a biorepository, and by FY18 the Boston Biorepository, Recruitment, and Integrative Network (BBRAIN) for GWI had been established to retain and distribute biospecimens and or related research data. Applicants are encouraged to contribute biospecimens and data to this resource to strengthen shared research capacity and improve consistency across studies. The Clinical Trial Award includes a nested Biorepository Contribution Option that can make a project eligible for higher funding levels, as long as the application meets the requirements laid out in the funding restrictions section.

To qualify for the higher funding level under the biorepository option, the Principal Investigator must include a formal Biorepository Contribution Statement with a clear breakdown of the costs involved and an explicit commitment to follow BBRAIN protocols and standard operating procedures for quality assurance. This is intended to ensure that samples and data collected across different trials are usable, comparable, and reliable for future research, helping the field build a stronger shared evidence base rather than isolated datasets.

Administratively, the opportunity is identified as W81XWH 18 GWIRP CTA and is offered by the Department of Defense, Department of the Army, through USAMRAA. It is categorized under science and technology and other research and development and is associated with CFDA number 12.420. Eligibility is listed as unrestricted, meaning it is broadly open to many types of organizations, subject to any additional eligibility notes in the full announcement. The original posting date was May 1, 2018, with an original closing date of November 8, 2018, and the program anticipated making about four awards.

• 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 "Gulf War Illness, 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 May 01, 2018.
• Applicants must submit their applications by Nov 08, 2018. (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 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.

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