Opportunity Information: Apply for W81XWH 13 GWIRP CTA
Apply for W81XWH 13 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 15, 2013 and posted on May 15, 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 $9,600,000.00 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 Clinical Trial Award (CTA) 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 purpose is to support larger, more definitive clinical trials that test promising interventions for Gulf War Illness (GWI) with the potential to meaningfully improve the health and daily functioning of affected Gulf War veterans. This mechanism is positioned for later-stage or more confirmatory studies, generally aligned with Phase II and Phase III clinical trials and, for devices, FDA device classes I through III. In parallel, GWIRP also offers a separate mechanism, the Innovative Treatment Evaluation Award (ITEA), meant for smaller early-phase or pilot trials and notably does not require preliminary data; the CTA, by contrast, does require preliminary support for the intervention and rationale.
The CTA emphasizes outcomes that reflect real clinical benefit for veterans living with a complex, multi-symptom condition. Applicants are encouraged to measure changes in global health indicators such as biomarkers and/or functional status, as well as improvements across key symptom clusters that commonly define GWI. These symptom complexes include issues like cognitive problems, musculoskeletal pain, gastrointestinal symptoms, fatigue, respiratory complaints, skin abnormalities, and sleep difficulties, with recognition that these symptoms can interact and overlap rather than appear in isolation. The program also highlights interest in studying distinct GWI subgroups defined by symptom patterns or other clinical characteristics, as long as the subgroup definitions are well justified and tied to a published GWI case definition that captures the multisystem nature of the illness.
A notable FY2013 update is that the CTA can support comparative effectiveness-style research and multi-center trials that directly compare GWI treatments. To encourage collaborative, multidisciplinary trial teams, the announcement includes a Multiple PI Option. Under this structure, an Initiating Principal Investigator can lead a team with up to three Partnering PIs, with each PI receiving a separate award while contributing equally to the project’s intellectual direction and effort. The Initiating PI is expected to have demonstrated expertise in GWI research, while Partnering PIs may bring complementary expertise from other relevant fields. For multi-organization projects, the application is expected to lay out practical coordination plans (communication, operations, and problem-solving) and show that participating institutions are prepared to address intellectual property and material-sharing issues so collaboration does not stall execution.
The program draws clear boundaries around what it will not fund through this announcement. Applications focused primarily on treating psychiatric conditions, including PTSD, are to be administratively withdrawn. The GWIRP also does not accept applications centered on ALS research under this opportunity, even though ALS rates are higher among Gulf War veterans; ALS-focused work is directed to a separate CDMRP ALS program. More broadly, CTA funds must be used to conduct a clinical trial and cannot be used for preclinical studies. The announcement defines a clinical trial in standard terms: prospective enrollment of human subjects in which an intervention (drug, device, biologic, procedure, rehabilitation modality, behavioral intervention, etc.) is tested to produce measurable outcomes related to safety, effectiveness, or efficacy.
From a readiness and feasibility standpoint, the CTA is designed for interventions that are sufficiently mature to justify a larger trial. Applications must include preliminary data, which can come from outside the GWI field, but should convincingly support the scientific rationale and indicate the intervention is reasonably developed. Projects lacking that kind of supporting data are considered a poor fit for the CTA and are instead steered toward the ITEA pilot-trial mechanism. Applicants also need to document that the intervention is actually available and accessible in adequate quantity and in a form ready to be used in a clinical trial setting, whether that is a drug/compound, device, or other modality.
Regulatory expectations are explicit. If the trial involves a drug not approved by FDA for the intended investigational use, the applicant must show that an Investigational New Drug (IND) submission has been made or will be made within 60 days after the award. Similarly, for devices, applicants must provide evidence of an Investigational Device Exemption (IDE) submission (or justification for IDE exemption) within the same timeframe. The government can withdraw funding if the IND/IDE is not submitted within 60 days of the award date, or if documented IND/IDE status is not obtained within 6 months, underscoring that the program is focused on trials that can move quickly into compliant execution.
Operationally, the proposed trial is expected to begin within 12 months of the award date. Applications need to show credible access to an appropriate Gulf War veteran population and present a realistic recruitment and accrual strategy, including how accrual goals will be met and how standards of care may affect the available participant pool. Collaboration with investigators who can access ill and healthy Gulf War veteran cohorts, particularly through the Department of Veterans Affairs, is encouraged. Methodological expectations include clearly defined endpoints, a well-articulated statistical analysis plan, appropriate statistical expertise, and a power analysis that demonstrates the proposed sample size can answer the study’s primary objectives. The announcement also calls for clinical trial management capacity, including study coordinator support to navigate IRB and regulatory processes, coordinate multi-site activities, and manage recruitment.
A key deliverable beyond the trial itself is a Transition Plan describing how the intervention will move forward if results are positive, whether that means progressing to the next clinical trial phase, preparing for broader implementation, or otherwise moving toward availability for ill Gulf War veterans. The application is also expected to demonstrate institutional support, reinforcing the program’s intent to fund trials that have the infrastructure and commitment needed to complete enrollment, execute the protocol, and produce interpretable results that can influence care.
In terms of administrative details, this was a discretionary funding opportunity (Funding Opportunity Number W81XWH-13-GWIRP-CTA) posted May 15, 2013, with a closing date of September 18, 2013, and an archive date of October 18, 2013. The activity aligns with CFDA 12.420 (Military Medical Research and Development), anticipated roughly three awards, and an estimated total funding amount of $9.6 million. Eligibility is listed as unrestricted (open to any entity type, subject to any additional eligibility notes in the full announcement), and cost sharing is not required.
DoD Gulf War Illness Clinical Trial Award (CTA) - FAQs
What is the DoD Gulf War Illness Clinical Trial Award (CTA)?
The CTA is a FY2013 funding opportunity under the Gulf War Illness Research Program (GWIRP) that supports larger, more definitive clinical trials evaluating promising interventions for Gulf War Illness (GWI) in Gulf War veterans. It is administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA) and CDMRP.
What is the main purpose of this award?
The purpose is to fund later-stage or more confirmatory clinical trials designed to test interventions that have the potential to meaningfully improve health and daily functioning for veterans affected by GWI.
What types of clinical trials is the CTA intended to support?
The CTA is positioned for later-stage studies generally aligned with Phase II and Phase III clinical trials. For device studies, it is aligned with FDA device classes I through III.
How is the CTA different from the Innovative Treatment Evaluation Award (ITEA)?
The CTA is intended for larger, more definitive trials and requires preliminary support for the intervention and scientific rationale. The ITEA mechanism is intended for smaller, early-phase or pilot trials and notably does not require preliminary data.
Does this opportunity require preliminary data?
Yes. Applications must include preliminary data that convincingly support the scientific rationale and show the intervention is sufficiently developed to justify a larger clinical trial. The preliminary data can come from outside the GWI field.
What kinds of interventions can be tested in a CTA-funded clinical trial?
The announcement describes a clinical trial as prospective enrollment of human subjects where an intervention is tested to produce measurable outcomes related to safety, effectiveness, or efficacy. Interventions may include drugs, devices, biologics, procedures, rehabilitation modalities, behavioral interventions, or other comparable modalities.
What outcomes does the CTA emphasize measuring?
The CTA emphasizes outcomes that reflect real clinical benefit for veterans living with GWI. Applicants are encouraged to measure changes in global health indicators such as biomarkers and/or functional status, as well as improvements across key symptom clusters commonly associated with GWI.
Which GWI symptom clusters are specifically highlighted?
The announcement notes symptom complexes that can include cognitive problems, musculoskeletal pain, gastrointestinal symptoms, fatigue, respiratory complaints, skin abnormalities, and sleep difficulties, recognizing these symptoms can overlap and interact.
Can applicants focus on specific subgroups of Gulf War Illness?
Yes. The program highlights interest in studying distinct GWI subgroups defined by symptom patterns or other clinical characteristics, as long as subgroup definitions are well justified and tied to a published GWI case definition that reflects the multisystem nature of the illness.
Does the FY2013 CTA allow comparative effectiveness research?
Yes. A noted FY2013 update is that the CTA can support comparative effectiveness-style research, including multi-center trials that directly compare GWI treatments.
Are multi-center clinical trials supported?
Yes. The announcement explicitly allows for multi-center trials and emphasizes practical coordination planning for multi-organization projects.
Is there an option to apply with multiple principal investigators (Multiple PI Option)?
Yes. The CTA includes a Multiple PI Option designed to encourage collaborative, multidisciplinary trial teams.
How does the Multiple PI Option work?
Under this structure, an Initiating Principal Investigator (PI) can lead a team with up to three Partnering PIs. Each PI receives a separate award while contributing equally to the project’s intellectual direction and effort.
What expertise is expected from the Initiating PI and Partnering PIs?
The Initiating PI is expected to have demonstrated expertise in GWI research. Partnering PIs may contribute complementary expertise from other relevant fields.
What coordination expectations apply to multi-organization or multi-site teams?
Applications are expected to include practical coordination plans covering communication, operations, and problem-solving. They also need to show participating institutions are prepared to address intellectual property and material-sharing issues so collaboration does not delay execution.
What types of applications will not be funded under this announcement?
The announcement draws clear boundaries. Applications focused primarily on treating psychiatric conditions, including PTSD, will be administratively withdrawn. Applications centered on ALS research are also not accepted under this opportunity.
Why are ALS-focused applications not accepted under this CTA?
Although ALS rates are higher among Gulf War veterans, ALS-focused work is directed to a separate CDMRP ALS program rather than this GWIRP CTA opportunity.
Can CTA funds be used for preclinical studies?
No. CTA funds must be used to conduct a clinical trial and cannot be used for preclinical studies.
What does the announcement consider a "clinical trial"?
A clinical trial is defined as prospective enrollment of human subjects in which an intervention is tested to produce measurable outcomes related to safety, effectiveness, or efficacy.
What evidence is required to show the intervention is ready for a clinical trial?
Applicants need to document that the intervention is available and accessible in adequate quantity and in a form ready for clinical trial use (whether a drug/compound, device, or other modality), and provide preliminary data supporting the rationale and development status.
What regulatory requirements apply if the trial uses a drug not approved by FDA for the intended investigational use?
The applicant must show that an Investigational New Drug (IND) submission has been made or will be made within 60 days after the award.
What regulatory requirements apply for device trials?
Applicants must provide evidence of an Investigational Device Exemption (IDE) submission, or provide justification for IDE exemption, within 60 days after the award.
What happens if IND or IDE requirements are not met on time?
The government can withdraw funding if the IND/IDE is not submitted within 60 days of the award date, or if documented IND/IDE status is not obtained within 6 months.
How soon is the trial expected to start after award?
The proposed clinical trial is expected to begin within 12 months of the award date.
What does the CTA expect regarding participant access and recruitment?
Applications need to show credible access to an appropriate Gulf War veteran population and provide a realistic recruitment and accrual strategy, including how accrual goals will be met and how standards of care may affect the available participant pool.
Is collaboration with the Department of Veterans Affairs (VA) encouraged?
Yes. Collaboration with investigators who can access ill and healthy Gulf War veteran cohorts, particularly through the VA, is encouraged.
What methodological and statistical elements are expected in the application?
The announcement calls for clearly defined endpoints, a well-articulated statistical analysis plan, appropriate statistical expertise, and a power analysis demonstrating that the sample size can answer the study’s primary objectives.
What clinical trial management capacity does the CTA expect?
The application is expected to demonstrate clinical trial management capacity, including study coordinator support to help navigate IRB and regulatory processes, coordinate multi-site activities, and manage recruitment.
What is a Transition Plan and why is it required?
A Transition Plan is a key deliverable describing how the intervention will move forward if results are positive, such as progressing to the next clinical trial phase, preparing for broader implementation, or otherwise moving toward availability for ill Gulf War veterans.
What is expected regarding institutional support?
The application is expected to demonstrate institutional support, reflecting the program intent to fund trials with the infrastructure and commitment needed to complete enrollment, execute the protocol, and produce interpretable results that can influence care.
What is the Funding Opportunity Number for this CTA?
The Funding Opportunity Number is W81XWH-13-GWIRP-CTA.
When was this funding opportunity posted and when did it close?
It was posted May 15, 2013, with a closing date of September 18, 2013. The archive date is October 18, 2013.
What CFDA program does this opportunity align with?
This activity aligns with CFDA 12.420 (Military Medical Research and Development).
How many awards and how much total funding were anticipated?
The opportunity anticipated roughly three awards with an estimated total funding amount of $9.6 million.
Who is eligible to apply?
Eligibility is listed as unrestricted (open to any entity type), subject to any additional eligibility notes contained in the full announcement.
Is cost sharing required?
No. Cost sharing is not required.
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