Opportunity Information: Apply for W81XWH 12 GWIRP ITEA
Apply for W81XWH 12 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 Mar 10, 2012 and posted on Mar 10, 2012.
- Applicants must submit their applications by Jul 24, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,440,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 2 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 FY12 funding opportunity under the Gulf War Illness Research Program (GWIRP) run through the Congressionally Directed Medical Research Programs (CDMRP). Its main purpose is to support early, systematic testing of promising treatments for Gulf War Illness (GWI) in smaller, pilot or early phase clinical trials. The idea is to generate credible proof-of-principle results that can justify and shape later, larger efficacy trials. This mechanism is positioned as the earlier-stage companion to the program's Clinical Trial Award (CTA), which is aimed at larger and more definitive Phase II or Phase III trials when there is already substantial preliminary and preclinical evidence.
A defining feature of the ITEA is its emphasis on innovation and early evaluation. Applicants are not required to provide preliminary data, and if they do include it, it does not need to come specifically from prior GWI studies. What matters is that the proposed clinical trial is grounded in a sound scientific rationale supported by careful reasoning and a critical review of the literature. At the same time, the program draws a clear line: if an intervention already has significant supporting development or preclinical evidence specifically pointing to applicability in GWI, the project may be considered insufficiently "innovative" for this mechanism and investigators are encouraged to pursue the CTA instead. Importantly, ITEA funds must be used for clinical trials, not preclinical research.
The award supports a broad range of intervention types with potential for real-world, widespread application to GWI. Eligible approaches include pharmacologic therapies, physiologic interventions, devices (FDA Class I through III), conventional treatments, complementary approaches, or combinations of these. The program is flexible about trial methodology, recognizing that early-stage intervention testing can take different forms depending on available evidence and resources. Acceptable prospective designs can include systematic case series, prospective outcome evaluations, small randomized trials, hybrid designs, or other creative prospective approaches, as long as they are evaluating an intervention in human participants. The announcement also highlights interest in interventions that are driven by biological alterations observed in veterans with GWI.
Outcomes are expected to be clinically meaningful and tied directly to the complex, multi-symptom reality of GWI. Trials should look at global health measures such as biomarkers and/or functional status, improvements across specific symptom complexes (for example cognition, musculoskeletal pain, gastrointestinal issues, fatigue, respiratory symptoms, skin problems, and sleep difficulties), and potential differences in response among GWI subgroups defined by symptom patterns or other clinical characteristics. The program is explicit about what it will not support: studies whose main focus is treatment of psychiatric conditions, including PTSD, are excluded. It also will not accept applications focused on ALS research, even though ALS is more common among Gulf War veterans; however, a GWI-focused study may include veterans with ALS if ALS is included within the study's GWI case definition, and applicants are pointed to a separate DOD ALS program for ALS-specific work.
A key application requirement is a clear, published case definition for identifying GWI participants, including any targeted subgroups. The case definition must reflect the multi-symptom nature of GWI, and applicants are expected to state explicitly how cases will be defined and selected. The announcement points applicants to the 2008 Research Advisory Committee on Gulf War Veterans' Illnesses report as a useful resource for background on case definitions and prior treatment research.
From a practical and regulatory standpoint, the ITEA expects applicants to be ready to run a real clinical trial promptly. The trial is expected to start within 12 months of the award date, and the intervention (drug/device/other) should be available in sufficient quantity and ready for clinical testing when the award is made. Applications must show access to an appropriate Gulf War veteran population and present a credible recruitment plan, including how accrual targets will be met and how standards of care might affect enrollment. Collaboration with investigators who have established access to ill and healthy Gulf War veteran populations, particularly within the Department of Veterans Affairs, is encouraged.
The program also stresses rigor in trial planning. Proposals should include clearly defined endpoints, a statistical analysis plan matched to the design, and a power analysis with sample size projections sufficient to address the study objectives. A study coordinator (or coordinators) should be included to manage IRB and other regulatory processes, coordinate multi-site operations if applicable, and support participant recruitment. Applicants must also provide a Transition Plan describing how the intervention will move to the next phase of clinical testing after successful completion, including potential funding sources and resources, along with evidence of institutional support.
Regulatory compliance is treated as a hard requirement where applicable. If an unapproved drug is involved, an FDA Investigational New Drug (IND) application must be submitted within 60 days of award. If an investigational device is involved, FDA Investigational Device Exemption (IDE) requirements may apply, and an IDE submission must also occur within 60 days if needed. The government reserves the right to withdraw funding if the IND/IDE status is not determined within 6 months of the award date, underscoring that awardees need to have a realistic regulatory path.
In terms of the published funding profile for this specific opportunity (W81XWH-12-GWIRP-ITEA), it was posted March 10, 2012, with a closing date of July 24, 2012, and an archive date of August 23, 2012. The agency is the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), with the CFDA listing under 12.420 (Military Medical Research and Development). The opportunity anticipated making about two awards with an estimated total funding amount of $1.44 million, did not require cost sharing or matching, and listed eligibility as unrestricted (open to any entity type, subject to any additional eligibility language in the full announcement).
Frequently Asked Questions (FAQs)
What is the DOD Gulf War Illness Innovative Treatment Evaluation Award (ITEA)?
The Innovative Treatment Evaluation Award (ITEA) is a FY12 funding mechanism under the Department of Defense (DOD) Gulf War Illness Research Program (GWIRP), administered through the Congressionally Directed Medical Research Programs (CDMRP). It is designed to support early, systematic testing of promising treatments for Gulf War Illness (GWI) in small, pilot, or early phase clinical trials.
What is the main purpose of the ITEA mechanism?
The main purpose is to generate credible proof-of-principle results from smaller clinical trials that can justify, inform, and shape later, larger efficacy trials. The emphasis is on early evaluation of interventions that are still considered innovative for GWI.
How is ITEA different from the GWIRP Clinical Trial Award (CTA)?
ITEA is positioned as an earlier-stage companion to the Clinical Trial Award (CTA). ITEA supports smaller, pilot or early phase trials to establish proof-of-principle. CTA is intended for larger and more definitive Phase II or Phase III trials when there is already substantial preliminary and preclinical evidence supporting the intervention for GWI.
Does the ITEA require preliminary data?
No. Applicants are not required to provide preliminary data. If preliminary data are included, they do not need to come from prior GWI studies.
If preliminary data are included, do they need to be specific to Gulf War Illness?
No. The program states that any preliminary data provided do not need to come specifically from prior GWI studies.
What matters most in the scientific justification if preliminary data are not required?
The proposed clinical trial must be supported by a sound scientific rationale, careful reasoning, and a critical review of the literature. The emphasis is on a well-argued, evidence-informed rationale for why the intervention should be tested in humans with GWI.
What does the program mean by "innovation" for this award?
Innovation is central to ITEA. If an intervention already has significant supporting development or preclinical evidence specifically pointing to applicability in GWI, it may be viewed as insufficiently innovative for ITEA, and investigators are encouraged to pursue the CTA instead.
Can ITEA funds be used for preclinical studies?
No. ITEA funds must be used for clinical trials and not for preclinical research.
What types of interventions are eligible for testing under ITEA?
The award supports a broad range of interventions with potential for real-world, widespread application to GWI, including pharmacologic therapies, physiologic interventions, devices (FDA Class I through III), conventional treatments, complementary approaches, and combinations of these.
Are medical devices eligible, and what device classes are included?
Yes. Devices are eligible, including FDA Class I, Class II, and Class III devices.
What kinds of clinical trial designs are acceptable?
The program is flexible for early-stage evaluation. Acceptable prospective designs can include systematic case series, prospective outcome evaluations, small randomized trials, hybrid designs, and other creative prospective approaches, as long as they involve evaluation of an intervention in human participants.
Do trials have to be prospective?
The announcement describes acceptable designs as prospective approaches (for example, prospective outcome evaluations and small randomized trials) that evaluate an intervention in human participants.
Is the program interested in biologically-driven interventions?
Yes. The announcement highlights interest in interventions driven by biological alterations observed in veterans with GWI.
What kinds of outcomes should an ITEA trial measure?
Outcomes are expected to be clinically meaningful and tied to the multi-symptom nature of GWI. Trials should consider global health measures such as biomarkers and/or functional status, improvements across symptom complexes (for example cognition, musculoskeletal pain, gastrointestinal issues, fatigue, respiratory symptoms, skin problems, and sleep difficulties), and potential differences in response among GWI subgroups.
Does the ITEA support studies focused primarily on psychiatric conditions like PTSD?
No. Studies whose main focus is treatment of psychiatric conditions, including PTSD, are excluded.
Does the ITEA accept applications focused on ALS research?
No. Applications focused on ALS research are not accepted under this opportunity, even though ALS is more common among Gulf War veterans.
Can a GWI-focused study include veterans with ALS?
Yes, a GWI-focused study may include veterans with ALS if ALS is included within the study's GWI case definition. For ALS-specific work, applicants are directed to a separate DOD ALS program.
Is a Gulf War Illness case definition required for the application?
Yes. A key requirement is a clear, published case definition for identifying GWI participants, including any targeted subgroups. The case definition must reflect the multi-symptom nature of GWI, and the application must state explicitly how cases will be defined and selected.
Are targeted subgroups allowed, and do they need to be defined?
Yes. The announcement allows targeting of subgroups, but applicants must specify the published case definition used and clearly describe how subgroups will be defined and selected.
Does the opportunity point to any resource on GWI case definitions?
Yes. The announcement points applicants to the 2008 Research Advisory Committee on Gulf War Veterans' Illnesses report as a useful resource for background on case definitions and prior treatment research.
How soon is the trial expected to begin after an award is made?
The trial is expected to start within 12 months of the award date.
Does the intervention need to be ready at the time of award?
Yes. The intervention (drug, device, or other) should be available in sufficient quantity and ready for clinical testing when the award is made.
Do applicants need to show access to Gulf War veteran participants?
Yes. Applications must demonstrate access to an appropriate Gulf War veteran population and include a credible recruitment plan describing how accrual targets will be met, including consideration of how standards of care might affect enrollment.
Is collaboration with the Department of Veterans Affairs encouraged?
Yes. Collaboration with investigators who have established access to ill and healthy Gulf War veteran populations, particularly within the Department of Veterans Affairs, is encouraged.
What planning and statistical elements are expected in the proposal?
Proposals should include clearly defined endpoints, a statistical analysis plan matched to the design, and a power analysis with sample size projections sufficient to address the study objectives.
Is a study coordinator required or expected?
A study coordinator (or coordinators) should be included to manage IRB and other regulatory processes, coordinate multi-site operations if applicable, and support participant recruitment.
What is a Transition Plan, and is it required?
A Transition Plan is required. It should describe how the intervention will move to the next phase of clinical testing after successful completion, including potential funding sources and resources, and include evidence of institutional support.
What are the IND requirements if the study involves an unapproved drug?
If an unapproved drug is involved, an FDA Investigational New Drug (IND) application must be submitted within 60 days of the award.
What are the IDE requirements if the study involves an investigational device?
If an investigational device is involved, FDA Investigational Device Exemption (IDE) requirements may apply, and an IDE submission must occur within 60 days of the award if needed.
What happens if IND or IDE status is not resolved in time?
The government reserves the right to withdraw funding if IND/IDE status is not determined within 6 months of the award date, indicating that awardees need a realistic regulatory path.
What is the opportunity number for this funding announcement?
The opportunity is identified as W81XWH-12-GWIRP-ITEA.
Who is the issuing agency for this opportunity?
The agency is the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), under the CDMRP framework.
What is the CFDA listing for this program?
The CFDA listing is 12.420 (Military Medical Research and Development).
When was this opportunity posted, and what were the key dates?
The opportunity was posted on March 10, 2012. The closing date was July 24, 2012, and the archive date was August 23, 2012.
How many awards and how much total funding were anticipated?
The announcement anticipated making about two awards with an estimated total funding amount of $1.44 million.
Is cost sharing or matching required?
No. The published opportunity information stated that cost sharing or matching was not required.
Who was eligible to apply?
Eligibility was listed as unrestricted (open to any entity type), subject to any additional eligibility language in the full announcement.
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