Opportunity Information: Apply for W81XWH 09 GWIRP CTA
Apply for W81XWH 09 GWIRP CTA
- 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 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 Military Medical Research and Development.
- This funding opportunity was created on Apr 21, 2009 and posted on Apr 21, 2009.
- Applicants must submit their applications by Sep 9, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,200,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 1 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 Clinical Trial Award (CTA) is a FY09 funding opportunity under the Gulf War Illness Research Program (GWIRP) designed to support larger, more definitive clinical trials aimed at finding effective interventions for veterans with Gulf War Illness (GWI). The CTA is positioned specifically for Phase II or Phase III studies where there is already enough preliminary and preclinical evidence to suggest the intervention could deliver meaningful benefit. In the same program year, GWIRP also offered a separate mechanism, the Innovative Treatment Evaluation Award (ITEA), which is meant for smaller, early-stage or pilot trials (Phase II or Phase I/II) and does not require preliminary data. In other words, the CTA targets treatments that are further along in development and ready to be tested in a more decisive way, while the ITEA is for earlier exploration.
The core purpose of the CTA is to enable rapid execution of high-impact clinical trials that could materially improve the health and daily functioning of veterans living with GWI. The program emphasizes outcomes that reflect real-world health changes, including global health measures and functional status, as well as key symptom domains commonly reported in GWI. These symptom complexes include cognitive issues, musculoskeletal and pain symptoms, gastrointestinal problems, fatigue, respiratory issues, and skin abnormalities. Applicants are expected to consider not only how individual symptom domains change, but also how symptom clusters may interact. The opportunity also encourages measurement of objective clinical outcomes and biomarkers where appropriate, and it explicitly recognizes the value of studying GWI subgroups defined by symptom patterns or other clinical characteristics.
Applications must clearly explain how GWI cases will be identified and how any targeted subgroup will be defined, since case definition and subgroup selection affect how results can be interpreted and generalized. The trial design must include clearly defined endpoints aligned to the proposed sample size and overall study design. The funder expects that assessed outcomes will cover both broad, global changes in health status and more specific objective measures when feasible, along with changes in the symptom domains most relevant to the intervention (for example pain, cognition, sleep, gastrointestinal symptoms, fatigue, or respiratory function). Each submission is limited to a single clinical trial with a distinct study design, rather than bundling multiple trials into one application.
Preliminary data is required for CTA applications, though it does not have to come directly from prior Gulf War Illness studies. The intent is that the intervention is sufficiently mature that existing evidence justifies moving into a larger Phase II or Phase III trial. Funding from this mechanism cannot be used for preclinical research, and the intervention (drug, device, or other treatment) is expected to be available and ready for clinical use in the trial, in sufficient quantities, at the time of award. Applicants are also encouraged to include correlative studies alongside the trial (such as biomarker or mechanistic components), but these must be described in detail with clear aims, methods, data management plans, and a statistical plan that is appropriately powered for the proposed analyses.
Operationally, the application is built around a full study protocol, which serves as the main body of the submission. Regulatory review is a major feature: the protocol must undergo review by the PI’s Institutional Review Board (IRB), the US Army Medical Research and Materiel Command (USAMRMC), and any other required regulatory bodies. Local IRB approval is not required at the time of submission, but the proposal must be realistic about achieving approvals and launching quickly. A named study coordinator is required, and this person is expected to manage the regulatory pathway across local IRB and USAMRMC processes, coordinate multi-site activities if applicable, and oversee participant accrual. The program also signals urgency and readiness by expecting the clinical trial to begin within 12 months of the award date.
The announcement places strong emphasis on feasibility and access to the Gulf War veteran population. Proposals need to explain how participants will be identified and recruited, how accrual targets will be met, what clinical resources will be used, and how standards of care might affect the study population or outcomes. Institutional support must be demonstrated, reinforcing that the applicant organization has the capacity to run a complex clinical trial on the expected timeline.
There are also clear topic boundaries. The trial must focus on Gulf War Illness itself rather than another disease process, even if symptoms overlap. Studies primarily aimed at treating psychiatric conditions, including PTSD, are not eligible under this announcement. The program also excludes proposals focused on ALS research, noting that a separate DOD ALS Research Program was offered in FY09 for that purpose.
From an administrative standpoint, this FY09 opportunity (Funding Opportunity Number W81XWH-09-GWIRP-CTA) was offered by the Department of the Army via USAMRAA, with a posted date of April 21, 2009, and an application deadline of September 9, 2009 (archived October 9, 2009). It used assistance instruments listed as cooperative agreement and grant, fell under CFDA 12.420 (Military Medical Research and Development), did not require cost sharing, and was open to unrestricted applicant types. The estimated total funding listed was $1,200,000, with an expected number of awards of 1. A key compliance note is that if an Investigational New Drug (IND) or Investigational Device Exemption (IDE) is required, the applicant should initiate or complete that process before submission; if IND/IDE approval is not obtained within six months after the award date, the government reserves the right to revoke funding.
FAQs: DOD Gulf War Illness Clinical Trial Award (CTA) (FY09)
What is the DOD Gulf War Illness Clinical Trial Award (CTA)?
The Gulf War Illness Clinical Trial Award (CTA) is a FY09 funding opportunity under the Department of Defense (DOD) Gulf War Illness Research Program (GWIRP) intended to support larger, more definitive clinical trials that test interventions for veterans with Gulf War Illness (GWI).
What is the main purpose of the CTA?
The CTA is designed to enable rapid execution of high-impact clinical trials that could materially improve the health and daily functioning of veterans living with GWI, with an emphasis on real-world outcomes like global health and functional status.
What clinical trial phases does the CTA support?
The CTA is positioned specifically for Phase II or Phase III studies where sufficient preliminary and preclinical evidence suggests the intervention could provide meaningful benefit.
How is the CTA different from the Innovative Treatment Evaluation Award (ITEA)?
In the same program year, GWIRP also offered the Innovative Treatment Evaluation Award (ITEA), which is intended for smaller, early-stage or pilot trials (Phase II or Phase I/II) and does not require preliminary data. By contrast, the CTA is for more mature interventions ready for a more definitive, larger trial and requires preliminary data.
Is preliminary data required to apply?
Yes. Preliminary data is required for CTA applications, although it does not have to come directly from prior Gulf War Illness studies. The intent is that the intervention is far enough along that existing evidence justifies a larger Phase II or Phase III clinical trial.
Can CTA funding be used for preclinical research?
No. Funding from this mechanism cannot be used for preclinical research.
Does the intervention need to be ready at the time of award?
Yes. The intervention (drug, device, or other treatment) is expected to be available and ready for clinical use in the trial, in sufficient quantities, at the time of award.
What types of outcomes does the CTA emphasize?
The program emphasizes outcomes that reflect real-world health changes, including global health measures and functional status, along with key symptom domains commonly reported in GWI.
Which Gulf War Illness symptom domains are specifically highlighted?
The announcement highlights multiple symptom complexes associated with GWI, including cognitive issues, musculoskeletal and pain symptoms, gastrointestinal problems, fatigue, respiratory issues, and skin abnormalities.
Do applicants need to consider symptom clusters, not just individual symptoms?
Yes. Applicants are expected to consider how individual symptom domains change and how symptom clusters may interact.
Are objective outcomes and biomarkers encouraged?
Yes. The opportunity encourages measurement of objective clinical outcomes and biomarkers where appropriate.
Can a trial focus on Gulf War Illness subgroups?
Yes. The announcement explicitly recognizes the value of studying GWI subgroups defined by symptom patterns or other clinical characteristics.
What must the application say about identifying Gulf War Illness cases?
Applications must clearly explain how GWI cases will be identified and, if applicable, how any targeted subgroup will be defined, because case definition and subgroup selection affect how results can be interpreted and generalized.
What does the CTA require regarding endpoints and trial design?
The trial design must include clearly defined endpoints aligned to the proposed sample size and overall study design. The funder expects outcomes to include broad global changes in health status and, when feasible, objective measures, along with changes in symptom domains most relevant to the intervention.
Can one application propose multiple clinical trials?
No. Each submission is limited to a single clinical trial with a distinct study design, rather than bundling multiple trials into one application.
Are correlative or mechanistic studies allowed alongside the trial?
Yes. Applicants are encouraged to include correlative studies (such as biomarker or mechanistic components), but these must be described in detail with clear aims, methods, data management plans, and a statistical plan that is appropriately powered for the proposed analyses.
What is the main component of the application package?
The application is built around a full study protocol, which serves as the main body of the submission.
What regulatory reviews are required?
The protocol must undergo review by the Principal Investigator (PI) institution's Institutional Review Board (IRB), the U.S. Army Medical Research and Materiel Command (USAMRMC), and any other required regulatory bodies.
Is local IRB approval required at the time of submission?
No. Local IRB approval is not required at the time of submission, but the proposal must be realistic about achieving approvals and launching quickly.
Is a study coordinator required?
Yes. A named study coordinator is required and is expected to manage the regulatory pathway across local IRB and USAMRMC processes, coordinate multi-site activities if applicable, and oversee participant accrual.
How soon is the clinical trial expected to begin after award?
The program expects the clinical trial to begin within 12 months of the award date.
What does the CTA emphasize about feasibility and recruitment?
The announcement places strong emphasis on feasibility and access to the Gulf War veteran population. Proposals need to explain how participants will be identified and recruited, how accrual targets will be met, what clinical resources will be used, and how standards of care might affect the study population or outcomes.
Is institutional support important?
Yes. Institutional support must be demonstrated to show the applicant organization has the capacity to run a complex clinical trial on the expected timeline.
What topic boundaries or exclusions apply?
The trial must focus on Gulf War Illness itself rather than another disease process, even if symptoms overlap. Studies primarily aimed at treating psychiatric conditions, including PTSD, are not eligible under this announcement. Proposals focused on ALS research are also excluded, as a separate DOD ALS Research Program was offered in FY09 for that purpose.
Who offered this funding opportunity and under what office?
This FY09 opportunity was offered by the Department of the Army via the U.S. Army Medical Research Acquisition Activity (USAMRAA).
What is the Funding Opportunity Number for this CTA?
The Funding Opportunity Number is W81XWH-09-GWIRP-CTA.
What were the key dates for this opportunity?
The opportunity was posted on April 21, 2009, had an application deadline of September 9, 2009, and was archived on October 9, 2009.
What assistance instruments were used?
The assistance instruments listed were cooperative agreement and grant.
What CFDA program is associated with this opportunity?
The opportunity fell under CFDA 12.420 (Military Medical Research and Development).
Was cost sharing required?
No. Cost sharing was not required.
Who was eligible to apply?
The opportunity was open to unrestricted applicant types.
How much total funding was estimated and how many awards were expected?
The estimated total funding listed was $1,200,000, with an expected number of awards of 1.
What IND/IDE compliance requirement should applicants be aware of?
If an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) is required, the applicant should initiate or complete that process before submission. If IND/IDE approval is not obtained within six months after the award date, the government reserves the right to revoke funding.
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