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.Apply for W81XWH 18 GWIRP CTA
- 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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FY18 Gulf War Illness Research Program (GWIRP) Clinical Trial Award - FAQs
1) What is the FY18 GWIRP Clinical Trial Award?
The FY18 Gulf War Illness Research Program (GWIRP) Clinical Trial Award is a Department of Defense funding opportunity intended to rapidly launch clinical trials that could make a meaningful difference for Veterans affected by Gulf War Illness (GWI). It is focused on real-world testing in people, with clinically relevant outcomes that improve health and day-to-day functioning.
2) What is the main goal of this award?
The main goal is to move promising interventions into clinical evaluation without unnecessary delay, prioritizing trials that are ready to be implemented and that have a plausible path to producing actionable results for GWI care.
3) Is this opportunity meant for lab or basic science research?
No. This award emphasizes clinical evaluation in people rather than basic or exploratory laboratory research. The program is centered on outcomes that matter clinically and functionally for Veterans with GWI.
4) What kinds of clinical trials are supported (small vs. large)?
The opportunity supports a wide range of clinical trials, from small early-stage efforts to larger definitive studies. Examples include proof-of-concept pilot studies, first-in-human work, Phase 0-style feasibility trials, and larger trials designed to determine efficacy in GWI Veteran populations.
5) What are examples of early-stage trial activities this award can fund?
Early-stage projects may include pilot studies or other proof-of-concept work intended to test feasibility, refine protocols, or generate key information needed to design a subsequent larger trial.
6) Can the award fund large-scale efficacy trials in Veterans with GWI?
Yes. In addition to early-stage trials, the award can support larger, more definitive clinical trials intended to determine efficacy in Gulf War Illness Veteran populations.
7) What types of interventions can be tested?
The solicitation allows a broad range of interventions, including new products, pharmacologic agents (including drugs or biologics), medical devices, clinical guidance approaches, and emerging technologies or treatment strategies.
8) What outcomes or symptoms should proposed trials focus on?
Proposals are expected to target outcomes that align with the multisystem symptom burden and functional limitations experienced by Veterans with GWI. The opportunity highlights overall functional status and symptom complexes such as cognitive problems, musculoskeletal and pain symptoms, gastrointestinal issues, fatigue, respiratory problems, skin abnormalities, sleep difficulties, and other related patterns.
9) What does the program mean by emphasizing functional outcomes?
The opportunity explicitly prioritizes outcomes that translate into improved day-to-day functioning and clinically meaningful changes, not just measurements that are primarily exploratory or mechanistic.
10) Are preliminary data required for early-phase or pilot trials?
Not necessarily. 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.
11) What counts as innovation for early-stage or pilot trials?
Innovation can mean testing something entirely new for GWI, or evaluating for the first time in Veterans with GWI an intervention that has been used in other chronic multisymptom illnesses.
12) Are preliminary data required for larger or more definitive trials?
Yes. For larger and more definitive clinical trials, including trials that build on earlier promising pilot results, applications must include preliminary data related to safety in a GWI Veteran population.
13) Why is safety data in a GWI Veteran population required for larger trials?
The solicitation links this requirement to the increased responsibility and potential impact that comes with scaling up to broader testing in the target Veteran population.
14) How should applicants think about the budget for this award?
Budgets are expected to match what is proposed. Requested funds should be appropriate for the phase, size, and complexity of the trial, and applicants must also follow additional limits and rules described in the funding restrictions section of the opportunity.
15) What funding mechanisms are used for this opportunity?
The award mechanism includes both grants and cooperative agreements. Depending on the structure used, there may be varying levels of involvement or oversight by the funding agency during project execution.
16) What is the optional Biorepository Contribution component introduced in FY18?
FY18 includes an optional Biorepository Contribution component connected to a newly established Gulf War Illness biorepository network. Applicants are encouraged to contribute biospecimens and/or related research data to strengthen shared research capacity and improve consistency across studies.
17) What is BBRAIN for GWI?
The Boston Biorepository, Recruitment, and Integrative Network (BBRAIN) for GWI was established to retain and distribute biospecimens and/or related research data. It builds on biorepository infrastructure funded in FY17.
18) Does participating in the biorepository option affect how much funding a project can request?
Yes. 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 requirements described in the funding restrictions section.
19) What is required to qualify for the higher funding level under the biorepository option?
To qualify for the higher funding level, the Principal Investigator must include a formal Biorepository Contribution Statement that provides a clear breakdown of associated costs and an explicit commitment to follow BBRAIN protocols and standard operating procedures for quality assurance.
20) Why does the program emphasize using BBRAIN protocols and SOPs?
The intent is to ensure that samples and data collected across different trials are usable, comparable, and reliable for future research, strengthening the shared evidence base rather than creating isolated datasets.
21) Who is the sponsoring agency for this opportunity?
This opportunity is offered by the Department of Defense, Department of the Army, through USAMRAA.
22) What is the opportunity identification number?
The opportunity is identified as W81XWH 18 GWIRP CTA.
23) What category is this opportunity listed under?
It is categorized under science and technology and other research and development.
24) What is the CFDA number associated with this opportunity?
The associated CFDA number is 12.420.
25) Who is eligible to apply?
Eligibility is listed as unrestricted, meaning it is broadly open to many types of organizations, subject to any additional eligibility notes that may appear in the full announcement.
26) When was the opportunity posted, and what was the closing date?
The original posting date was May 1, 2018. The original closing date was November 8, 2018.
27) How many awards did the program anticipate making?
The program anticipated making about four awards.
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