Opportunity Information: Apply for W81XWH 15 GWIRP ITEA
Apply for W81XWH 15 GWIRP ITEA
- The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Gulf War Illness Innovative 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 Military Medical Research and Development.
- This funding opportunity was created on Jul 8, 2015 and posted on May 14, 2015.
- Applicants must submit their applications by Oct 29, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,400,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 3 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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Opportunity Summary:
The DoD Gulf War Illness (GWIRP) Innovative Treatment Evaluation Award is a Department of the Army (USAMRAA) funding opportunity designed to support early, systematic testing of promising treatments for Gulf War Illness (GWI) in Veterans of the 1990 to 1991 Gulf War. The main goal is to generate credible, early-stage clinical evidence (often described as clinical proof-of-principle) that can justify and shape larger, more definitive efficacy trials later on. In practical terms, this mechanism is meant to help researchers move from a plausible treatment idea to initial human data in the specific GWI Veteran population, with a clear emphasis on potential real-world impact on Veterans health and daily functioning.
This award specifically funds pilot clinical trials, meaning early phase studies such as Phase 0, Phase I, or Phase I/II. A key feature is that preliminary data are not required, which lowers the barrier for genuinely new or under-tested ideas to be evaluated. Even though preliminary data are optional, proposals still need to be grounded in a solid scientific rationale built from careful reasoning and a critical review of existing literature. The program draws a clear line between this mechanism and the separate GWIRP Clinical Trial Award: if a treatment already has substantial preliminary or preclinical support and is ready for a larger Phase II or Phase III-style evaluation (or FDA device class I to III trials), that work is expected to be proposed under the Clinical Trial Award rather than this pilot-focused mechanism.
Innovation is central to how applications are expected to stand out. Innovation can mean testing a completely novel therapeutic approach for GWI, but it can also mean repurposing or adapting an intervention that has been used for other chronic multisymptom illnesses (such as fibromyalgia or chronic fatigue syndrome) but has not yet been evaluated specifically in Veterans with GWI. The program is explicit that the research focus must remain on Gulf War Illness and the 1990 to 1991 Gulf War Veteran cohort, not on a different disease process or a different Veteran group. The scope of interventions is intentionally broad and can include pharmacologic treatments, nutritional supplements, other physiological interventions, and conventional, complementary, or alternative approaches, including combination approaches.
The opportunity allows flexibility in study design, acknowledging that early-stage intervention evaluation may require methods other than large randomized controlled trials. Acceptable prospective designs can include systematic case series, prospective outcome evaluation studies, small-scale randomized trials, hybrids of these approaches, or other creative prospective methods suited to the intervention and the available evidence. The announcement also highlights interest in interventions that target biological alterations identified in Veterans with GWI, signaling that mechanistically informed therapies are welcome when they are tied clearly to GWI. Importantly, the program treats any study that involves an intervention as a clinical trial, regardless of whether it is randomized or uses another design.
From an outcomes perspective, the program prioritizes measures that reflect meaningful improvements in Veterans lives. This includes overall functional status as well as changes in major symptom domains commonly associated with GWI, such as cognitive difficulties, musculoskeletal pain, gastrointestinal problems, fatigue, respiratory issues, skin abnormalities, and sleep disturbance. The announcement also notes that symptom complexes may be studied individually or in terms of how they interact, which fits the multisystem nature of GWI and encourages applicants to think beyond single-symptom endpoints when appropriate.
Administrative details indicate this was a FY15 discretionary funding opportunity (Funding Opportunity Number W81XWH-15-GWIRP-ITEA) offered as a cooperative agreement or grant under CFDA 12.420 (Military Medical Research and Development). Cost sharing was not required, eligibility was listed as unrestricted, and the opportunity anticipated about three awards with an estimated total funding level of approximately $3.4 million. 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. For access issues, the announcement referenced the CDMRP Help Desk at 301-682-5507.
Frequently Asked Questions (FAQs)
What is the DoD Gulf War Illness (GWIRP) Innovative Treatment Evaluation Award?
The GWIRP Innovative Treatment Evaluation Award is a Department of Defense (DoD) funding opportunity administered by the U.S. Army Medical Research Acquisition Activity (USAMRAA). It is designed to support early, systematic testing of promising treatments for Gulf War Illness (GWI) in Veterans of the 1990 to 1991 Gulf War.
What is the main goal of this award?
The main goal is to generate credible early-stage clinical evidence (often described as clinical proof-of-principle) that can justify, inform, and shape larger and more definitive efficacy trials later.
What kind of studies does this award fund?
This award specifically funds pilot clinical trials, including early phase studies such as Phase 0, Phase I, or Phase I/II. The intent is to help move from a plausible treatment idea to initial human data in the specific Gulf War Illness Veteran population.
Are preliminary data required to apply?
No. Preliminary data are not required, which is intended to reduce barriers for genuinely new or under-tested ideas. However, proposals still need to be supported by a solid scientific rationale based on careful reasoning and a critical review of existing literature.
If preliminary data are optional, what still needs to be strong in the application?
The scientific rationale must be well supported through logic and a critical review of existing evidence. Even without preliminary data, the proposal is expected to make a compelling case for why the treatment should be tested in Gulf War Illness Veterans.
How is this award different from the GWIRP Clinical Trial Award?
This mechanism is pilot-focused (Phase 0, Phase I, or Phase I/II). If a treatment already has substantial preliminary or preclinical support and is ready for larger Phase II or Phase III-style evaluation (or FDA device class I to III trials), that work is expected to be proposed under the separate GWIRP Clinical Trial Award rather than this Innovative Treatment Evaluation Award.
Who is the intended study population?
The intended population is Veterans of the 1990 to 1991 Gulf War who have Gulf War Illness. The research focus must remain on Gulf War Illness and this specific Veteran cohort, not another disease process or a different Veteran group.
What types of interventions can be tested?
The scope is broad and can include pharmacologic treatments, nutritional supplements, other physiological interventions, and conventional, complementary, or alternative approaches. Combination approaches are also included within the scope.
What does the program mean by "innovation"?
Innovation can mean testing a completely novel therapeutic approach for Gulf War Illness. It can also mean repurposing or adapting an intervention used for other chronic multisymptom illnesses (such as fibromyalgia or chronic fatigue syndrome) that has not yet been evaluated specifically in Veterans with Gulf War Illness.
Does the study design have to be a large randomized controlled trial (RCT)?
No. The opportunity allows flexibility in study design because early-stage intervention evaluation may require alternatives to large RCTs. Acceptable prospective designs may include systematic case series, prospective outcome evaluation studies, small-scale randomized trials, hybrids of these approaches, or other creative prospective methods suited to the intervention and available evidence.
Are non-randomized intervention studies considered clinical trials under this opportunity?
Yes. The program treats any study that involves an intervention as a clinical trial, regardless of whether it is randomized or uses another prospective design.
Is the program interested in mechanistically informed treatments?
Yes. The announcement highlights interest in interventions that target biological alterations identified in Veterans with Gulf War Illness, as long as the connection to Gulf War Illness is clearly explained.
What outcomes does the program prioritize?
The program prioritizes outcomes that reflect meaningful improvements in Veterans lives, including overall functional status and changes in major symptom domains commonly associated with Gulf War Illness.
Which symptom domains are specifically mentioned as priorities?
Examples of major symptom domains include cognitive difficulties, musculoskeletal pain, gastrointestinal problems, fatigue, respiratory issues, skin abnormalities, and sleep disturbance.
Can a study focus on a single symptom area or multiple symptom domains?
Yes. Symptom complexes may be studied individually or in terms of how they interact. This aligns with the multisystem nature of Gulf War Illness and supports approaches that consider more than a single-symptom endpoint when appropriate.
What was the Funding Opportunity Number for this announcement?
The Funding Opportunity Number was W81XWH-15-GWIRP-ITEA.
What funding mechanism was used?
The opportunity was offered as a cooperative agreement or grant.
What CFDA listing was associated with this opportunity?
The CFDA listing was 12.420, Military Medical Research and Development.
Was cost sharing required?
No. Cost sharing was not required.
Who was eligible to apply?
Eligibility was listed as unrestricted.
How many awards and how much total funding were anticipated?
The announcement anticipated about three awards, with an estimated total funding level of approximately $3.4 million.
When was this opportunity posted and when did it close?
The posting date was May 14, 2015. The original and final closing date was October 29, 2015.
Is this opportunity archived?
Yes. The archive date was November 28, 2015.
Who should be contacted for access issues related to the announcement?
For access issues, the announcement referenced the CDMRP Help Desk at 301-682-5507.
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