Opportunity Information: Apply for W81XWH 14 GWIRP CTA
Apply for W81XWH 14 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 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 $5,200,000.00 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 FY14 funding opportunity under the Gulf War Illness Research Program (GWIRP) run through the Department of the Army/USAMRAA and CDMRP. Its purpose is to support larger, more definitive clinical trials that test interventions intended to meaningfully improve the health and day-to-day functioning of Gulf War veterans affected by Gulf War Illness (GWI). Compared with the program's other mechanism, the Innovative Treatment Evaluation Award (ITEA), which is meant for smaller early-phase or pilot trials and does not require preliminary data, the CTA is aimed at later-stage efforts such as Phase II or Phase III drug trials and FDA device studies spanning Class I to Class III. The CTA is explicitly designed for interventions that are sufficiently mature to justify a more rigorous, resource-intensive trial and to produce results that could change clinical practice or accelerate a product toward broader use.
Projects funded under the CTA must be true clinical trials, meaning they prospectively enroll human participants and test an intervention (which could include drugs, devices, biologics, surgery, rehabilitation approaches, behavioral interventions, or other modalities) while measuring outcomes related to safety, effectiveness, and/or efficacy. The program is open to single-site or multi-site trials, and it allows comparative studies, so applicants can propose head-to-head comparisons between treatments rather than only placebo-controlled designs. Outcomes of interest include global health measures such as biomarkers and functional status, improvements in key symptom clusters commonly seen in GWI (for example cognitive problems, pain and musculoskeletal symptoms, gastrointestinal issues, fatigue, respiratory complaints, skin problems, and sleep difficulties), and differential effects across GWI subgroups defined by symptom patterns or other clinical characteristics. A central expectation is that the application clearly identifies the pathobiological mechanism being targeted, rather than testing an intervention without a well-argued rationale.
A notable feature of this opportunity is the Multiple PI Option, which is built to encourage genuinely collaborative projects that combine expertise across disciplines or organizations. Under this structure, up to four investigators can serve as PIs on a single synergistic project, with one acting as the Initiating PI responsible for most administrative coordination and up to three serving as Partnering PIs. The intent is that the team shares intellectual leadership and effort, with the Initiating PI bringing demonstrated expertise in GWI research and the Partnering PIs potentially contributing specialized skills from other fields that can move GWI treatment research forward. When more than one organization is involved, the application is expected to spell out how communication will work across sites and confirm that partners are prepared to handle intellectual and material property issues in a way that does not obstruct cooperation.
The announcement also sets clear boundaries on what will and will not be considered. Applications primarily focused on treating psychiatric conditions, including PTSD, are administratively withdrawn and are not eligible under this funding opportunity. The program also does not accept applications focused on ALS, even though ALS rates are elevated among Gulf War veterans; ALS-centered proposals are directed to the separate CDMRP ALS Research Program. That said, a GWI-focused study may include Gulf War veterans who have ALS only if ALS is included within the study's GWI case definition, and the project remains centered on GWI symptomatology.
Because case definition is a major source of variability in GWI research, applicants must clearly state how GWI cases and any targeted subgroups will be defined and must cite a published case definition that recognizes GWI as a multisymptom illness. The announcement points applicants to key references, including the 2014 Research Advisory Committee report on Gulf War Illness and an Institute of Medicine report examining and recommending consensus case definitions. Importantly, CTA applications must include preliminary data, though it does not have to originate within the GWI field, as long as it supports the logic, feasibility, and maturity of the proposed intervention. Proposals lacking substantial preliminary or preclinical development are considered outside the CTA's intent and are encouraged to pursue the ITEA mechanism instead.
Regulatory and operational readiness is emphasized throughout. CTA-funded trials must be positioned to start relatively quickly: within 12 months of award for non-FDA-regulated studies, or within 18 months for FDA-regulated studies. If the trial involves a drug not approved by the FDA for the intended investigational use, the applicant must provide evidence that an IND (or IND exemption, as applicable) has been or will be submitted within 60 days of award. Device studies must similarly provide evidence of an IDE submission within 60 days, or documentation that the device is IDE-exempt. The government reserves the right to withdraw funding if these submissions are not made on time or if documented IND/IDE status is not obtained within 6 months of the award date.
From a review standpoint, the application is expected to look like a well-prepared, execution-ready clinical trial package. Applicants need to show documented access to the intervention materials (drug/device/compound and related supplies) and that product quality aligns with relevant FDA manufacturing standards such as GMP or Quality System Regulation where applicable. They must also demonstrate access to a suitable Gulf War veteran participant population and provide a credible recruitment and accrual plan, including discussion of how standards of care could affect enrollment; collaboration with investigators who have established access to Gulf War veterans, particularly within the Department of Veterans Affairs, is encouraged. The protocol should include clear endpoints, adhere to Good Clinical Practice guidelines when applicable, and include a robust statistical analysis plan with power/sample-size justification. The announcement also calls for concrete data management, safety management, and clinical monitoring plans; an identified study coordinator or coordinators who can drive IRB and regulatory approvals and coordinate multi-site operations; strong institutional support; and a Transition Plan describing how the intervention will move to the next clinical phase and/or toward market delivery if the trial is successful. Finally, awardees are expected to commit to registering the study on ClinicalTrials.gov.
Administratively, the opportunity was posted May 7, 2014, with a closing date of September 25, 2014 (archived October 25, 2014). It is listed under Funding Opportunity Number W81XWH-14-GWIRP-CTA and CFDA 12.420 (Military Medical Research and Development). The funding instrument is described as a cooperative agreement and/or grant under a discretionary research and development category, with an estimated total funding level of $5.2 million and an expectation of one award. Eligibility is listed as unrestricted in general terms, subject to any additional eligibility clarifications in the full announcement. For technical access issues, the CDMRP Help Desk is the listed point of contact (301-682-5507).
FAQs - DoD Gulf War Illness Clinical Trial Award (CTA) (FY14)
What is the Gulf War Illness Clinical Trial Award (CTA)?
The Gulf War Illness Clinical Trial Award (CTA) is a FY14 funding opportunity under the Department of Defense Gulf War Illness Research Program (GWIRP), managed through the Department of the Army/USAMRAA and CDMRP. It is intended to fund larger, more definitive clinical trials of interventions aimed at meaningfully improving the health and day-to-day functioning of Gulf War veterans affected by Gulf War Illness (GWI).
What is the purpose of this award?
The purpose is to support later-stage, rigorous, resource-intensive clinical trials designed to produce results that could change clinical practice or help move a product toward broader use. The CTA is focused on interventions mature enough to justify a more definitive trial.
How is the CTA different from the Innovative Treatment Evaluation Award (ITEA)?
The ITEA mechanism is intended for smaller early-phase or pilot trials and does not require preliminary data. In contrast, the CTA targets later-stage efforts (such as Phase II or Phase III trials and FDA device studies) and requires preliminary data demonstrating the intervention is sufficiently developed and feasible for a larger trial.
What types of studies are eligible under the CTA?
Projects must be true clinical trials. That means they must prospectively enroll human participants, test an intervention, and measure outcomes related to safety, effectiveness, and/or efficacy.
What types of interventions can be studied?
The opportunity allows a wide range of intervention modalities, including drugs, devices, biologics, surgery, rehabilitation approaches, behavioral interventions, and other modalities, as long as the project meets the definition of a clinical trial and targets GWI-related outcomes.
Are both single-site and multi-site trials allowed?
Yes. The CTA is open to both single-site and multi-site clinical trials.
Can applicants propose comparative studies (head-to-head trials) instead of placebo-controlled designs?
Yes. The program allows comparative studies, including head-to-head comparisons between treatments, and does not limit applicants to placebo-controlled designs.
What outcomes is the program interested in measuring?
Outcomes of interest include global health measures (such as biomarkers and functional status), improvements in key Gulf War Illness symptom clusters, and differential effects across GWI subgroups defined by symptom patterns or other clinical characteristics.
Which Gulf War Illness symptom clusters are specifically mentioned?
Examples listed include cognitive problems, pain and musculoskeletal symptoms, gastrointestinal issues, fatigue, respiratory complaints, skin problems, and sleep difficulties.
Does the application need to explain the biological rationale for the intervention?
Yes. A central expectation is that the application clearly identifies the pathobiological mechanism being targeted, rather than testing an intervention without a well-argued rationale.
What is the Multiple PI Option?
The CTA includes a Multiple PI Option intended to encourage collaborative projects that combine expertise across disciplines or organizations. Under this option, up to four investigators can serve as PIs on one project.
How many Principal Investigators (PIs) can be included under the Multiple PI Option?
Up to four PIs can be named: one Initiating PI and up to three Partnering PIs.
What is the role of the Initiating PI versus Partnering PIs?
The Initiating PI is responsible for most administrative coordination and is expected to have demonstrated expertise in Gulf War Illness research. Partnering PIs are intended to contribute specialized skills (potentially from other fields) that strengthen the project. The structure is designed for shared intellectual leadership and effort.
If multiple organizations are involved, what does the application need to address?
The application is expected to describe how communication will work across sites and confirm that partners are prepared to handle intellectual and material property issues in a way that does not obstruct cooperation.
Are applications focused on PTSD or other psychiatric conditions eligible?
No. Applications primarily focused on treating psychiatric conditions, including PTSD, are administratively withdrawn and are not eligible under this opportunity.
Are ALS-focused proposals eligible under this opportunity?
No. The program does not accept applications focused on ALS. ALS-centered proposals are directed to the separate CDMRP ALS Research Program.
Can a GWI-focused study include Gulf War veterans who have ALS?
Yes, but only if ALS is included within the study's GWI case definition and the project remains centered on Gulf War Illness symptomatology rather than ALS.
Do applicants have to use a specific Gulf War Illness case definition?
Applicants must clearly state how GWI cases and any targeted subgroups will be defined and must cite a published case definition that recognizes GWI as a multisymptom illness. The announcement emphasizes that case definition variability is a major issue in GWI research.
Does the CTA require preliminary data?
Yes. CTA applications must include preliminary data. The preliminary data does not have to come from within the GWI field, but it must support the logic, feasibility, and maturity of the proposed intervention.
What happens if a proposal lacks substantial preliminary or preclinical development?
Proposals lacking substantial preliminary or preclinical development are considered outside the CTA's intent and are encouraged to pursue the ITEA mechanism instead.
How quickly must CTA-funded trials be able to start after award?
Trials must be positioned to start relatively quickly: within 12 months of award for non-FDA-regulated studies, or within 18 months for FDA-regulated studies.
What are the IND requirements for drug studies?
If the trial involves a drug not approved by the FDA for the intended investigational use, the applicant must provide evidence that an IND (or IND exemption, as applicable) has been or will be submitted within 60 days of award.
What are the IDE requirements for device studies?
Device studies must provide evidence of an IDE submission within 60 days of award, or documentation that the device is IDE-exempt. The CTA covers FDA device studies spanning Class I through Class III.
Can funding be withdrawn for missed IND/IDE timelines?
Yes. The government reserves the right to withdraw funding if IND/IDE submissions are not made on time or if documented IND/IDE status is not obtained within 6 months of the award date.
What evidence of readiness is expected in the application?
The application is expected to resemble an execution-ready clinical trial package. It should show documented access to intervention materials and supplies, appropriate product quality aligned with relevant FDA manufacturing standards (such as GMP or Quality System Regulation where applicable), and credible plans for recruitment, operations, and oversight.
What does the CTA expect regarding access to participants and recruitment?
Applicants must demonstrate access to a suitable Gulf War veteran participant population and provide a credible recruitment and accrual plan, including discussion of how standards of care could affect enrollment. Collaboration with investigators who have established access to Gulf War veterans, particularly within the Department of Veterans Affairs, is encouraged.
What does the protocol need to include?
The protocol should include clear endpoints and a robust statistical analysis plan with power and sample-size justification. Where applicable, it should adhere to Good Clinical Practice guidelines.
What operational and oversight plans are expected?
The announcement calls for concrete data management, safety management, and clinical monitoring plans, as well as identified study coordinator(s) who can drive IRB and regulatory approvals and coordinate multi-site operations. Strong institutional support is also expected.
Is a Transition Plan required?
Yes. The application should include a Transition Plan describing how the intervention will move to the next clinical phase and/or toward market delivery if the trial is successful.
Is ClinicalTrials.gov registration required?
Yes. Awardees are expected to commit to registering the study on ClinicalTrials.gov.
What is the Funding Opportunity Number and CFDA listing?
The Funding Opportunity Number is W81XWH-14-GWIRP-CTA. The CFDA listing is 12.420 (Military Medical Research and Development).
What is the funding instrument for this opportunity?
The announcement describes the funding instrument as a cooperative agreement and/or grant under a discretionary research and development category.
How much funding was available and how many awards were expected?
The estimated total funding level was $5.2 million, with an expectation of one award.
When was this opportunity posted and when did it close?
The opportunity was posted May 7, 2014, with a closing date of September 25, 2014. It was archived October 25, 2014.
Who is eligible to apply?
Eligibility is listed as unrestricted in general terms, subject to any additional eligibility clarifications in the full announcement.
Who should applicants contact for technical access issues?
For technical access issues, the listed point of contact is the CDMRP Help Desk at 301-682-5507.
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