Opportunity Information: Apply for W81XWH 13 GWIRP ITEA
Apply for W81XWH 13 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 May 14, 2013 and posted on May 14, 2013.
- Applicants must submit their applications by Sep 18, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,160,000.00 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 Innovative Treatment Evaluation Award (ITEA) is a FY2013 funding opportunity under the Gulf War Illness Research Program (GWIRP) run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) and CDMRP. Its main purpose is to fund early, systematic testing of promising treatments for Gulf War Illness (GWI) in smaller, pilot or early-phase clinical trials, specifically Phase II or Phase I/II studies, including studies of medical devices across FDA Classes I through III. Unlike the companion GWIRP Clinical Trial Award (CTA), which is aimed at larger and more definitive Phase II or Phase III trials backed by stronger preliminary and preclinical evidence, the ITEA is intentionally positioned earlier in the pipeline and does not require preliminary data. The intent is to generate proof-of-principle results that can justify and shape subsequent, larger efficacy trials.
A key theme of the ITEA mechanism is innovation, defined broadly. Projects can be considered innovative if they test a genuinely new therapeutic idea for GWI, but they can also qualify by translating an intervention used or suggested for related chronic multi-symptom illnesses (like fibromyalgia or chronic fatigue syndrome) into the Gulf War veteran population, provided the study is clearly focused on GWI rather than another condition. The program is open to a wide range of intervention types, including pharmacologic treatments, nutritional supplements, physiological interventions, conventional and complementary approaches, and combinations of methods. In addition, the announcement encourages interventions that are grounded in biological alterations identified in veterans with GWI, reflecting an interest in treatments linked to plausible underlying mechanisms.
The award requires that funded work be a clinical trial, using the program’s broad definition: a prospective study that enrolls human subjects and tests an intervention (such as a drug, biologic, device, procedure, rehabilitation modality, behavioral intervention, or similar) to measure outcomes related to safety, effectiveness, efficacy, and/or exploratory endpoints. Because of this requirement, ITEA funds cannot be used for preclinical research, and investigators with strictly preclinical plans are expected to pursue other GWIRP mechanisms. While the program accepts a variety of prospective designs, it emphasizes rigor and fit-for-purpose planning, allowing options such as systematic case series, prospective outcome studies, small randomized trials, or other innovative prospective approaches depending on the intervention, resources, and current evidence base.
The health outcomes of interest are focused on real-world impact for ill Gulf War veterans. Applicants are encouraged to measure changes in global health indicators (which may include biomarkers) and/or functional status, improvements across key symptom complexes (for example cognitive problems, pain and musculoskeletal symptoms, gastrointestinal issues, fatigue, respiratory complaints, skin problems, and sleep difficulties), and differential effects in clinically meaningful GWI subgroups defined by symptom patterns or other characteristics. At the same time, the program draws clear boundaries around what it will not fund: studies primarily targeting psychiatric conditions (including PTSD) are excluded, and applications focused on ALS are not accepted under GWIRP (though veterans with ALS may be included if they meet the study’s GWI case definition and the trial is truly about GWI symptomatology). Applicants must also be explicit about how they will define GWI and any targeted subgroups, including citing a published case definition that captures GWI as a multi-symptom illness.
Even though preliminary data are not required, the proposed trial still has to rest on a solid scientific rationale supported by careful reasoning and literature analysis. The program also signals that if an intervention is already backed by substantial preclinical and preliminary clinical development suggesting it is ready for a more definitive test, that may be considered outside the ITEA’s innovation intent, and the applicant may be better suited for the GWIRP Clinical Trial Award instead. Operationally, the ITEA emphasizes readiness to execute: trials are expected to start within 12 months of the award date, and applications must demonstrate access to a suitable population of Gulf War veterans to meet accrual goals, with encouragement to collaborate with investigators who have established access to both ill and healthy Gulf War veteran cohorts, particularly within the VA system.
Regulatory planning is another major requirement. If the project involves an unapproved drug for the proposed indication, the applicant must show that an FDA Investigational New Drug (IND) submission has been made or will be made within 60 days of award. For devices, an Investigational Device Exemption (IDE) submission (or documentation of exemption) is similarly required within 60 days. The government reserves the right to withdraw funding if these submissions are not made on time, or if the documented status is not obtained within six months. Applications are also expected to include practical trial infrastructure: clearly defined endpoints, a statistical analysis plan with appropriate expertise and power/sample size justification, study coordination support to manage IRB and other approvals and multi-site logistics, documented access to the intervention materials (drug/device/compound), strong institutional backing, and a transition plan that explains how the project will move to the next clinical trial phase if results are positive, including likely resources and future funding pathways.
From an administrative perspective, this FY2013 opportunity (Funding Opportunity Number W81XWH-13-GWIRP-ITEA) was offered as a grant/cooperative agreement within the Military Medical Research and Development CFDA area (12.420). The total estimated funding was about $2.16 million with an expectation of around three awards, and there was no cost-sharing requirement. Eligibility was listed as unrestricted (open broadly to applicant types, subject to any additional eligibility notes in the full announcement). The original application deadline was September 18, 2013, with the posting date of May 14, 2013, and an archive date of October 18, 2013.
FAQs: DoD Gulf War Illness Innovative Treatment Evaluation Award (ITEA) - FY2013
What is the Gulf War Illness Innovative Treatment Evaluation Award (ITEA)?
The ITEA is a FY2013 funding opportunity under the Department of Defense (DoD) Gulf War Illness Research Program (GWIRP), administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA) and CDMRP. It supports early, systematic testing of promising treatments for Gulf War Illness (GWI) through smaller, pilot or early-phase clinical trials.
What is the main goal of the ITEA?
The main goal is to generate proof-of-principle results from early clinical testing that can justify and inform later, larger efficacy trials for Gulf War Illness.
What types of clinical trials does ITEA support?
ITEA supports Phase II or Phase I/II clinical trials, including clinical studies of medical devices across FDA Classes I through III, as long as the work meets the program's definition of a clinical trial.
How does ITEA differ from the GWIRP Clinical Trial Award (CTA)?
ITEA is positioned earlier in the treatment-development pipeline and focuses on smaller, early-phase trials. It does not require preliminary data. In contrast, the GWIRP Clinical Trial Award (CTA) is aimed at larger and more definitive Phase II or Phase III trials that are supported by stronger preliminary and preclinical evidence.
Is preliminary data required to apply?
No. Preliminary data are not required for ITEA. However, the proposed trial must still be supported by a solid scientific rationale, careful reasoning, and literature analysis.
What does the program mean by "innovation"?
Innovation is defined broadly. A project may be innovative by testing a genuinely new therapeutic idea for GWI, or by translating an intervention used or suggested for related chronic multi-symptom illnesses (such as fibromyalgia or chronic fatigue syndrome) into the Gulf War veteran population, as long as the study is clearly focused on GWI.
What kinds of interventions are allowed?
A wide range of intervention types are allowed, including pharmacologic treatments, nutritional supplements, physiological interventions, conventional and complementary approaches, and combinations of methods. The announcement also encourages interventions grounded in biological alterations identified in veterans with GWI.
Does the funded project have to be a clinical trial?
Yes. Funded work must be a clinical trial under the program's broad definition: a prospective study enrolling human subjects that tests an intervention (for example, a drug, biologic, device, procedure, rehabilitation modality, behavioral intervention, or similar) to measure outcomes such as safety, effectiveness, efficacy, and/or exploratory endpoints.
Can ITEA funds be used for preclinical research?
No. ITEA funds cannot be used for preclinical research. Investigators whose plans are strictly preclinical are expected to pursue other GWIRP mechanisms.
What prospective study designs are acceptable?
The program accepts a variety of prospective designs and emphasizes rigor and fit-for-purpose planning. Examples mentioned include systematic case series, prospective outcome studies, small randomized trials, and other innovative prospective approaches that match the intervention, available resources, and current evidence base.
What outcomes does the ITEA want applicants to measure?
Applicants are encouraged to measure real-world impact for ill Gulf War veterans, including changes in global health indicators (which may include biomarkers) and/or functional status. The program also encourages measurement of improvements across key symptom complexes such as cognitive problems, pain and musculoskeletal symptoms, gastrointestinal issues, fatigue, respiratory complaints, skin problems, and sleep difficulties.
Does the program encourage analyses of subgroups of Gulf War Illness?
Yes. The opportunity encourages evaluating differential effects in clinically meaningful GWI subgroups defined by symptom patterns or other characteristics. Applicants must be explicit about how they define GWI and any targeted subgroups.
How must Gulf War Illness be defined in an application?
Applicants are expected to clearly define GWI and any targeted subgroups, including citing a published case definition that captures GWI as a multi-symptom illness.
Are studies primarily targeting psychiatric conditions eligible?
No. Studies primarily targeting psychiatric conditions (including PTSD) are excluded under this opportunity.
Are ALS-focused applications eligible under GWIRP ITEA?
No. Applications focused on ALS are not accepted under GWIRP. However, veterans with ALS may be included if they meet the study's GWI case definition and the trial is truly focused on GWI symptomatology.
What if the intervention is already well developed and ready for a large definitive trial?
The announcement indicates that if an intervention is already supported by substantial preclinical and preliminary clinical development and appears ready for a more definitive test, it may be outside the ITEA's innovation intent, and the applicant may be better suited for the GWIRP Clinical Trial Award (CTA) instead.
How soon are trials expected to begin after an award is made?
Trials are expected to start within 12 months of the award date.
What does the program require regarding participant access and recruitment?
Applications must demonstrate access to a suitable population of Gulf War veterans to meet accrual goals. Collaboration is encouraged with investigators who have established access to both ill and healthy Gulf War veteran cohorts, particularly within the VA system.
What are the regulatory requirements for unapproved drugs?
If the project involves an unapproved drug for the proposed indication, the applicant must show that an FDA Investigational New Drug (IND) submission has been made or will be made within 60 days of award.
What are the regulatory requirements for medical devices?
For device studies, an Investigational Device Exemption (IDE) submission (or documentation of exemption) is required within 60 days of award.
What happens if IND/IDE submissions are not made on time or status is not obtained?
The government reserves the right to withdraw funding if required submissions are not made within the stated timeline, or if the documented status is not obtained within six months.
What trial infrastructure elements are expected in an application?
Applications are expected to include clearly defined endpoints, a statistical analysis plan with appropriate expertise and power/sample size justification, study coordination support for IRB and other approvals and multi-site logistics, documented access to the intervention materials (drug/device/compound), and strong institutional backing.
Is a transition plan required?
Yes. Applications are expected to include a transition plan describing how the project will move to the next clinical trial phase if results are positive, including likely resources and future funding pathways.
What is the Funding Opportunity Number for this ITEA announcement?
The Funding Opportunity Number is W81XWH-13-GWIRP-ITEA.
What CFDA area is associated with this opportunity?
This opportunity falls under the Military Medical Research and Development CFDA area, 12.420.
How much total funding was estimated, and how many awards were expected?
The total estimated funding was about $2.16 million, with an expectation of around three awards.
Was cost sharing required?
No cost-sharing requirement was listed for this opportunity.
Who was eligible to apply?
Eligibility was listed as unrestricted (open broadly to applicant types), subject to any additional eligibility notes in the full announcement.
When was the opportunity posted, and what were the key dates?
The posting date was May 14, 2013. The original application deadline was September 18, 2013. The archive date was October 18, 2013.
Which agencies and programs administered this opportunity?
The opportunity was part of the DoD GWIRP and was run through USAMRAA and CDMRP.
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