Opportunity Information: Apply for W81XWH 14 GWIRP ITEA
Apply for W81XWH 14 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 7, 2014 and posted on May 7, 2014.
- Applicants must submit their applications by Sep 25, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,100,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 6 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 FY14 funding opportunity under the Gulf War Illness Research Program (GWIRP) that supports early clinical testing of promising treatments for Gulf War Illness (GWI) in Gulf War veterans. It is meant for smaller, early-phase or pilot clinical trials, including Phase 0, Phase I, or Phase I/II studies, and for medical devices across FDA Class I through III. The central goal is to generate practical, clinical proof-of-principle evidence that a treatment is safe, feasible, and potentially beneficial, so that successful projects can move into larger, more definitive efficacy trials later on. Unlike later-stage trial mechanisms, this award is explicitly designed to encourage new ideas, so applicants are not required to provide preliminary data in a GWI model system, and any preliminary data included do not have to come from the GWI field as long as the overall rationale is strong and clearly tied to GWI.
A key point in this announcement is how the ITEA differs from the companion GWIRP Clinical Trial Award (CTA). The CTA is intended for larger Phase II or Phase III trials where there is already substantial preliminary and preclinical support suggesting the intervention could provide meaningful benefit for veterans with GWI. In contrast, the ITEA is where investigators take an innovative approach and test it in a smaller, earlier trial to establish an initial signal and inform whether a bigger study is warranted. The program also makes it clear that if a proposed intervention already has extensive supporting evidence and is relatively far along in development for GWI, it may be considered insufficiently innovative for ITEA and would be a better fit for the CTA mechanism.
The scope of interventions eligible under ITEA is broad and intentionally flexible. Proposed treatments can include pharmacologic or other physiological interventions, and they can come from conventional medicine, complementary and integrative approaches, alternative modalities, or thoughtful combinations of these. The program is open to a variety of prospective study designs that match the maturity of the idea and the practical realities of clinical research in this population. Examples include systematic case series, prospective outcome evaluations, small-scale randomized trials, hybrid approaches, and other well-justified innovative trial designs. The announcement also highlights interest in interventions that are grounded in biological alterations identified in veterans with GWI, reinforcing that projects should connect the intervention to a plausible pathobiological mechanism.
The outcomes the DoD is looking for go beyond a single symptom and reflect the multisystem nature of GWI. Applicants are encouraged to assess global health measures, including biomarkers and/or functional status, and to evaluate improvement across symptom complexes such as cognitive problems, musculoskeletal pain, gastrointestinal issues, fatigue, respiratory symptoms, skin abnormalities, and sleep difficulties, including how these clusters may interact. The opportunity also encourages attention to GWI subgroups defined by symptom patterns or other clinical characteristics, which matters because GWI can present heterogeneously and a treatment may work best for a subset of veterans.
There are important boundaries on what the program will and will not fund. Trials whose main purpose is treatment of psychiatric conditions, including PTSD, are explicitly not eligible under this announcement. The program also will not accept applications focused on ALS, even though ALS occurs at higher rates among Gulf War veterans. However, veterans with ALS may be included in a study if the application is truly centered on GWI symptomatology and ALS is encompassed within the study case definition for GWI. Applicants must clearly define what counts as a GWI case for their study and must use a published case definition that recognizes the multisymptom nature of the illness. The announcement points investigators to major reference documents, including the 2014 Research Advisory Committee report and an Institute of Medicine report discussing case definitions and recommendations.
The award funds clinical trials only and cannot be used for preclinical research. The announcement uses a standard definition of a clinical trial: prospective enrollment of human subjects where an intervention is tested to produce measurable outcomes related to safety, effectiveness, efficacy, or exploratory objectives. Because many interventions may require FDA oversight, the opportunity includes concrete regulatory expectations. If a study uses a drug not approved for the proposed use, the applicant must be prepared to submit an IND (or document an exemption) within 60 days of award. If a device is involved, an IDE (or an 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 IND/IDE status is not documented within six months.
Operational readiness is a major emphasis. Trials are expected to begin within 12 months of the award date, or within 18 months for FDA-regulated studies. Applicants must show they can realistically recruit an appropriate Gulf War veteran population and achieve accrual targets, including explaining how standards of care may influence recruitment. Collaboration with investigators who have established access to Gulf War veteran cohorts, particularly within the Department of Veterans Affairs, is encouraged. Applications are also expected to demonstrate access to the intervention materials (drug, compound, device, etc.) with product quality appropriate for the stage of development and consistent with applicable FDA manufacturing expectations, such as Good Manufacturing Practices or Quality System Regulation where relevant.
From a trial quality standpoint, the DoD expects applications to look like serious clinical development packages, even if the study is early phase. That includes clearly defined endpoints, adherence to Good Clinical Practice, a detailed statistical analysis plan with appropriate expertise and power/sample size justification, and robust plans for data management, safety management, and clinical monitoring for compliance. The announcement also expects applicants to designate study coordination capacity to manage IRB and regulatory processes, multi-site coordination if applicable, and participant accrual. Another distinctive requirement is a Transition Plan: investigators must explain how, if the study is successful, the intervention will move to the next clinical phase and/or toward real-world availability, including likely funding sources and resources needed. Applicants must also show strong institutional support and commit to registering the trial on ClinicalTrials.gov.
Administratively, this opportunity was posted May 7, 2014, with an original and final closing date of September 25, 2014, and an archive date of October 25, 2014. It was issued by the Department of the Army, USAMRAA, under Funding Opportunity Number W81XWH-14-GWIRP-ITEA, CFDA 12.420 (Military Medical Research and Development). The mechanism is listed as a cooperative agreement/grant within science and technology research and development, with an estimated total funding level of $4.1 million and an expected six awards. Eligibility is described as unrestricted, meaning a wide range of organization types may apply, and there is no cost sharing or matching requirement stated.
Frequently Asked Questions (FAQs)
What is the DoD Gulf War Illness Innovative Treatment Evaluation Award (ITEA)?
The Gulf War Illness Innovative Treatment Evaluation Award (ITEA) is a FY14 funding opportunity under the Department of Defense (DoD) Gulf War Illness Research Program (GWIRP). It supports early clinical testing of promising treatments for Gulf War Illness (GWI) in Gulf War veterans, with the aim of generating practical proof-of-principle evidence that an intervention is safe, feasible, and potentially beneficial.
What is the main purpose of the ITEA mechanism?
The central goal is to produce early clinical evidence (proof-of-principle) that can justify moving a treatment into larger, more definitive efficacy trials later. The emphasis is on early-stage clinical testing rather than later-stage confirmatory studies.
What types of clinical trial phases are supported?
ITEA is designed for smaller, early-phase or pilot clinical trials, including Phase 0, Phase I, and Phase I/II studies. It also supports medical device studies across FDA device Classes I, II, and III.
How is ITEA different from the GWIRP Clinical Trial Award (CTA)?
ITEA supports innovative approaches tested in smaller, earlier trials to establish an initial signal and determine whether a larger study is warranted. The companion Clinical Trial Award (CTA) is intended for larger Phase II or Phase III trials and is more appropriate when there is already substantial preliminary and preclinical support for meaningful benefit in GWI.
If an intervention already has extensive evidence in GWI, is it a good fit for ITEA?
Not necessarily. The announcement notes that if a proposed intervention is relatively far along in development for GWI and already has extensive supporting evidence, it may be considered insufficiently innovative for ITEA and may be better suited to the CTA mechanism.
Are applicants required to provide preliminary data in a Gulf War Illness model system?
No. ITEA is explicitly designed to encourage new ideas, so preliminary data in a GWI model system are not required.
Can preliminary data come from outside the Gulf War Illness field?
Yes. Any preliminary data included do not have to come from the GWI field, as long as the overall rationale is strong and clearly tied to Gulf War Illness.
What kinds of interventions are eligible?
The scope is broad and intentionally flexible. Interventions can include pharmacologic or other physiological treatments and may come from conventional medicine, complementary and integrative approaches, alternative modalities, or well-justified combinations of these.
What study designs are allowed under ITEA?
The opportunity is open to a range of prospective study designs that fit the maturity of the intervention and practical realities of clinical research in this population. Examples mentioned include systematic case series, prospective outcome evaluations, small-scale randomized trials, hybrid approaches, and other innovative designs with strong justification.
Does the program expect a biological rationale for the intervention?
Yes. The announcement highlights interest in interventions grounded in biological alterations identified in veterans with GWI. Applications should connect the intervention to a plausible pathobiological mechanism relevant to GWI.
What outcomes does the DoD want measured in ITEA studies?
The DoD encourages outcomes that reflect the multisystem nature of GWI. Applicants are encouraged to assess global health measures, including biomarkers and/or functional status, and evaluate improvements across symptom complexes such as cognitive problems, musculoskeletal pain, gastrointestinal issues, fatigue, respiratory symptoms, skin abnormalities, and sleep difficulties, including potential interactions among symptom clusters.
Are studies focused on subgroups of Gulf War Illness allowed?
Yes. The announcement encourages attention to GWI subgroups defined by symptom patterns or other clinical characteristics, recognizing that GWI is heterogeneous and an intervention may work best for a subset of veterans.
Are trials primarily focused on psychiatric conditions eligible?
No. Trials whose main purpose is treatment of psychiatric conditions, including PTSD, are explicitly not eligible under this announcement.
Are ALS-focused applications eligible?
No. The program will not accept applications focused on ALS, even though ALS occurs at higher rates among Gulf War veterans.
Can veterans with ALS be included in an ITEA-funded study?
Yes, but only under a specific condition: veterans with ALS may be included if the application is truly centered on GWI symptomatology and ALS is encompassed within the study case definition for GWI.
Do applicants need to define what counts as a Gulf War Illness case?
Yes. Applicants must clearly define what constitutes a GWI case for their study and must use a published case definition that recognizes the multisymptom nature of the illness.
Does ITEA fund preclinical research?
No. The award funds clinical trials only and cannot be used for preclinical research.
What does the announcement consider a "clinical trial"?
The announcement uses a standard definition: a clinical trial involves prospective enrollment of human subjects where an intervention is tested to produce measurable outcomes related to safety, effectiveness, efficacy, or exploratory objectives.
What FDA regulatory requirements apply to drug studies?
If the study uses a drug that is not approved for the proposed use, the applicant must be prepared to submit an Investigational New Drug (IND) application (or document an exemption) within 60 days of the award.
What FDA regulatory requirements apply to device studies?
If a device is involved, an Investigational Device Exemption (IDE) submission (or documentation of an exemption) is similarly required within 60 days of the award.
What happens if IND/IDE submissions are not made on time?
The government reserves the right to withdraw funding if IND/IDE submissions are not made within the required timeframe or if IND/IDE status is not documented within six months.
When are trials expected to begin after an award is made?
Trials are expected to begin within 12 months of the award date, or within 18 months for FDA-regulated studies.
What does the program expect regarding recruitment and accrual feasibility?
Applicants must show they can realistically recruit an appropriate Gulf War veteran population and achieve accrual targets. The application should also address how standards of care may influence recruitment.
Is collaboration with the Department of Veterans Affairs (VA) encouraged?
Yes. Collaboration with investigators who have established access to Gulf War veteran cohorts, particularly within the VA, is encouraged.
Do applicants need to show access to the intervention product (drug/device/compound)?
Yes. Applications are expected to demonstrate access to intervention materials and confirm that product quality is appropriate for the development stage and consistent with applicable FDA manufacturing expectations, such as Good Manufacturing Practices (GMP) or Quality System Regulation (QSR), where relevant.
What clinical trial quality elements are expected in the application?
Even though the studies are early phase, applications are expected to resemble serious clinical development packages. The announcement emphasizes clearly defined endpoints, adherence to Good Clinical Practice (GCP), a detailed statistical analysis plan with appropriate expertise and power/sample size justification, and robust plans for data management, safety management, and clinical monitoring for compliance.
Is study coordination capacity required?
Yes. The announcement expects applicants to designate coordination capacity to manage IRB and regulatory processes, multi-site coordination (if applicable), and participant accrual.
What is the Transition Plan requirement?
A Transition Plan is a distinctive requirement of ITEA. Investigators must explain how a successful study will move the intervention to the next clinical phase and/or toward real-world availability, including likely funding sources and the resources needed.
Is institutional support expected?
Yes. The announcement states that applicants must show strong institutional support.
Is ClinicalTrials.gov registration required?
Yes. Applicants must commit to registering the trial on ClinicalTrials.gov.
Who issued this funding opportunity?
This opportunity was issued by the Department of the Army, USAMRAA.
What is the Funding Opportunity Number?
The Funding Opportunity Number is W81XWH-14-GWIRP-ITEA.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 12.420 (Military Medical Research and Development).
What type of funding mechanism is used?
The mechanism is listed as a cooperative agreement/grant within science and technology research and development.
How much total funding was estimated, and how many awards were expected?
The estimated total funding level was $4.1 million, with an expected six awards.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning a wide range of organization types may apply.
Is cost sharing or matching required?
No cost sharing or matching requirement is stated in the provided information.
When was the opportunity posted, and what were the closing dates?
The opportunity was posted May 7, 2014. The original and final closing date was September 25, 2014, and the archive date was October 25, 2014.
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