Opportunity Information: Apply for W81XWH 13 GWIRP CTA MPIO
Apply for W81XWH 13 GWIRP CTA MPIO
- 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 with Multiple PI Option" 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 Jul 11, 2013 and posted on Jul 11, 2013.
- Applicants must submit their applications by Nov 25, 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) with Multiple PI Option is a FY13 funding opportunity under the Department of the Army, USAMRAA, within the Congressionally Directed Medical Research Programs (CDMRP) Gulf War Illness Research Program (GWIRP). It is designed to fund larger, more definitive clinical trials aimed at improving the health and daily functioning of veterans suffering from Gulf War Illness (GWI). In practical terms, this mechanism is meant for interventions that are ready for a substantial test in people, typically Phase II or Phase III trials, and it also covers medical devices across FDA device classes I through III. The overarching emphasis is on trials that could realistically make a meaningful difference for ill Gulf War veterans rather than exploratory or purely preclinical work.
The program distinguishes the CTA from a companion mechanism offered the same year, the Innovative Treatment Evaluation Award (ITEA). The ITEA is meant for earlier-stage or pilot clinical trials (Phase II or Phase I/II) and, importantly, does not require preliminary data. The CTA, by contrast, expects applicants to bring preliminary data and a well-supported scientific rationale, even if the preliminary evidence comes from outside the GWI field. If a proposed treatment does not yet have sufficient development or supporting data, the announcement signals that it likely does not fit the CTA intent and should instead be routed to the ITEA. Another key boundary is that CTA funds must support an actual clinical trial and cannot be used for preclinical studies; investigators wanting preclinical support are directed to a different GWIRP mechanism (Investigator-Initiated Research Award).
The CTA is oriented around clinical outcomes that matter to veterans with GWI and recognizes that GWI is multi-symptom and heterogeneous. The opportunity specifically highlights outcomes such as global health measures (including biomarkers) and/or functional status, as well as improvements in symptom complexes like cognitive problems, musculoskeletal pain, gastrointestinal symptoms, fatigue, respiratory issues, skin abnormalities, and sleep difficulties. It also encourages work that can shed light on subgroups of GWI defined by symptom patterns or other clinical characteristics, including how symptom clusters may interact. New for FY13, the CTA explicitly allows comparative research and multi-center trials that compare treatments, reflecting an interest in more definitive head-to-head evidence that could influence care decisions.
A central feature of this announcement is the Multiple PI Option, which is meant to promote genuinely collaborative, synergistic teams. Under this structure, up to four investigators can serve as PIs on a single coordinated project, with one designated as the Initiating PI and up to three as Partnering PIs. Each PI receives a separate award but all are expected to contribute at an equal intellectual level toward one unified clinical trial effort, whether that is testing an innovative modality or comparing untested or novel treatments for GWI symptoms. The Initiating PI carries most of the administrative load, and the Partnering PIs have specific application responsibilities described in the program materials. The announcement encourages multidisciplinary and multi-organizational teams, but expects applicants to plan for effective communication across sites and to address potential intellectual property and material transfer barriers up front so collaboration is not slowed or undermined during execution.
There are clear topic boundaries and administrative exclusions. Applications whose main focus is the treatment of psychiatric conditions, including PTSD, will be administratively withdrawn (meaning they will not move forward in review under this announcement). The program also will not accept applications focused on ALS, even though Gulf War veterans have elevated ALS rates; ALS-focused work is redirected to a separate FY13 CDMRP ALS research program. In addition, applications must explicitly define how GWI cases (and any targeted subgroups) will be identified in the study, and they must cite a published case definition that reflects the multi-symptom nature of GWI. The announcement points applicants to the 2008 Research Advisory Committee on Gulf War Veterans' Illnesses report as a resource for case definitions and context on past treatment research.
From a trial-readiness and compliance standpoint, the CTA has several operational expectations. Trials are expected to begin within 12 months of the award date, which pushes teams to have protocols, staffing, site logistics, and regulatory pathways well developed at submission. Applicants need to show they have reliable access to the intervention (drug, device, biologic, procedure, rehabilitation approach, behavioral intervention, etc.) in sufficient quantities and in a form that is ready for clinical testing. They also must demonstrate access to an appropriate Gulf War veteran population and present a credible recruitment and accrual plan, including consideration of how standards of care might affect enrollment. Collaboration with investigators who have established access to ill and healthy Gulf War veteran populations, especially within the Department of Veterans Affairs, is encouraged.
Methodologically, the application is expected to look like a serious, definitive clinical trial package: clearly defined endpoints, appropriate statistical expertise, a detailed statistical analysis plan, and a power analysis that justifies sample size and shows the trial can answer its primary objectives. The announcement also calls for study coordination capacity to handle Institutional Review Board (IRB) and other regulatory processes, coordinate multi-site activities if applicable, and manage participant recruitment. Beyond the trial itself, applicants must include a Transition Plan describing how the tested product or approach will move forward after the CTA, either into the next clinical phase and/or toward delivery and adoption for the ill Gulf War veteran population, including likely resources and funding pathways. Evidence of institutional support is also required, underscoring that the DoD expects the host organization(s) to back the infrastructure needed to run the study.
Regulatory requirements are spelled out for investigational products. If the trial involves a drug not FDA-approved for the proposed investigational use, the application must include evidence that an Investigational New Drug (IND) submission has been made or will be made within 60 days of award. For devices, similar expectations apply for an Investigational Device Exemption (IDE), including the option to document exemption where applicable. The government reserves the right to withdraw funding if the IND or IDE is not submitted within 60 days of the award date or if documented status is not obtained within six months, making regulatory follow-through a hard requirement rather than a formality.
Administratively, this opportunity (Funding Opportunity Number W81XWH-13-GWIRP-CTA-MPIO) is listed as a discretionary program using a cooperative agreement/grant structure, under CFDA 12.420 (Military Medical Research and Development). It was posted July 11, 2013, with a closing date of November 25, 2013, and anticipated making about three awards with an estimated total funding level of $9.6 million. Eligibility is described as unrestricted (open to any type of entity, subject to any additional eligibility clarifications in the full announcement), and there is no cost-sharing or matching requirement stated. The help desk contact provided is the CDMRP Help Desk at 301-682-5507 for applicants needing assistance accessing the full announcement.
FAQs: DoD Gulf War Illness Clinical Trial Award (CTA) with Multiple PI Option (FY13)
What is the Gulf War Illness Clinical Trial Award (CTA) with Multiple PI Option?
It is a FY13 funding opportunity under the Department of the Army (USAMRAA) within the Congressionally Directed Medical Research Programs (CDMRP) Gulf War Illness Research Program (GWIRP). The CTA is intended to fund larger, more definitive clinical trials designed to improve health and daily functioning in veterans with Gulf War Illness (GWI). A Multiple PI Option is included to support a coordinated, collaborative team approach.
What is the main purpose of this award mechanism?
The purpose is to support clinical trials that are ready for substantial testing in people and could realistically make a meaningful difference for ill Gulf War veterans. The focus is on definitive trials rather than exploratory or preclinical work.
What kinds of clinical trials are expected (Phase I, II, III)?
This mechanism is intended for interventions that are ready for a substantial test in humans, typically Phase II or Phase III trials. The companion FY13 mechanism (ITEA) is positioned for earlier-stage or pilot clinical trials (Phase II or Phase I/II).
Are medical devices eligible, and what device classes are covered?
Yes. The opportunity covers medical devices across FDA device classes I through III.
Is a clinical trial required, or can funds be used for preclinical research?
An actual clinical trial is required. CTA funds cannot be used for preclinical studies. Investigators seeking preclinical support are directed to another GWIRP mechanism, the Investigator-Initiated Research Award.
How is this CTA different from the Innovative Treatment Evaluation Award (ITEA)?
The CTA is aimed at larger, more definitive clinical trials and expects preliminary data and a well-supported scientific rationale (even if the preliminary evidence comes from outside the GWI field). The ITEA is meant for earlier-stage or pilot trials and does not require preliminary data. If a proposed treatment lacks sufficient development or supporting data, the announcement indicates it likely fits ITEA rather than CTA.
Does the CTA require preliminary data?
Yes. Applicants are expected to provide preliminary data and a strong scientific rationale. The preliminary evidence may come from outside the GWI field, but it must support the rationale for testing the intervention in a GWI clinical trial.
What types of interventions can be tested under this CTA?
The announcement describes a broad range of possible interventions, including drugs, devices, biologics, procedures, rehabilitation approaches, and behavioral interventions, provided they are ready for clinical testing and align with the intent of conducting a definitive clinical trial in GWI.
What outcomes does the program emphasize for Gulf War Illness trials?
The CTA emphasizes outcomes that matter to veterans with GWI, including global health measures (including biomarkers) and/or functional status. It also highlights improvements in symptom complexes such as cognitive problems, musculoskeletal pain, gastrointestinal symptoms, fatigue, respiratory issues, skin abnormalities, and sleep difficulties.
Does the program recognize that GWI is multi-symptom and heterogeneous?
Yes. The opportunity explicitly notes that GWI is multi-symptom and heterogeneous and encourages research that can address this complexity in clinically meaningful ways.
Are studies on GWI subgroups encouraged?
Yes. The CTA encourages work that can shed light on subgroups of GWI defined by symptom patterns or other clinical characteristics, including how symptom clusters may interact.
Are comparative effectiveness or head-to-head treatment studies allowed?
Yes. New for FY13, the CTA explicitly allows comparative research and multi-center trials that compare treatments, reflecting interest in more definitive head-to-head evidence that could influence care decisions.
Are multi-center trials allowed or encouraged?
Yes. Multi-center trials are explicitly allowed, and the announcement underscores the need for effective coordination and communication across participating sites.
What is the Multiple PI Option, and how many PIs can be included?
The Multiple PI Option is designed to promote truly collaborative, synergistic teams. Up to four investigators may serve as PIs on a single coordinated project: one Initiating PI and up to three Partnering PIs.
How are awards handled under the Multiple PI Option?
Each PI receives a separate award, but all PIs are expected to contribute at an equal intellectual level toward one unified clinical trial effort.
What is the difference between the Initiating PI and Partnering PIs?
The Initiating PI carries most of the administrative load for the overall effort. Partnering PIs have specific application responsibilities described in the program materials, and all PIs are expected to contribute substantially and collaboratively to the unified trial.
Does the program expect plans for collaboration logistics and potential barriers?
Yes. Applicants are expected to plan for effective communication across sites and to address potential intellectual property and material transfer barriers up front so collaboration is not slowed or undermined during execution.
Are there topic areas that are excluded or cause an application to be withdrawn?
Yes. Applications whose main focus is the treatment of psychiatric conditions, including PTSD, will be administratively withdrawn and will not proceed to review under this announcement.
Is ALS research allowed under this opportunity?
No. Applications focused on ALS will not be accepted under this opportunity, even though Gulf War veterans have elevated ALS rates. ALS-focused work is directed to the separate FY13 CDMRP ALS research program.
How must applicants define Gulf War Illness cases in the proposed study?
Applications must explicitly define how GWI cases (and any targeted subgroups) will be identified in the study and must cite a published case definition that reflects the multi-symptom nature of GWI.
Is there a recommended resource for GWI case definitions and prior research context?
Yes. The announcement points applicants to the 2008 Research Advisory Committee on Gulf War Veterans' Illnesses report as a resource for case definitions and context on past treatment research.
How quickly must the trial begin after award?
Trials are expected to begin within 12 months of the award date, which implies that protocols, staffing, site logistics, and regulatory pathways should be well developed by the time of submission.
What does the opportunity require regarding access to the intervention being tested?
Applicants must show they have reliable access to the intervention (for example, a drug or device) in sufficient quantities and in a form that is ready for clinical testing.
What does the program expect regarding participant access and recruitment?
Applicants must demonstrate access to an appropriate Gulf War veteran population and provide a credible recruitment and accrual plan. The announcement also notes that applicants should consider how standards of care might affect enrollment.
Is collaboration with the Department of Veterans Affairs (VA) encouraged?
Yes. Collaboration with investigators who have established access to ill and healthy Gulf War veteran populations, especially within the VA, is encouraged.
What methodological elements are expected in the application?
The application is expected to present a definitive clinical trial package, including clearly defined endpoints, appropriate statistical expertise, a detailed statistical analysis plan, and a power analysis that justifies sample size and demonstrates the trial can answer its primary objectives.
What operational or coordination capabilities are expected for the trial?
The announcement calls for study coordination capacity to handle IRB and other regulatory processes, coordinate multi-site activities if applicable, and manage participant recruitment.
Is a Transition Plan required, and what should it address?
Yes. Applicants must include a Transition Plan describing how the tested product or approach will move forward after the CTA, either into the next clinical phase and/or toward delivery and adoption for the ill Gulf War veteran population. The plan should include likely resources and funding pathways.
Is institutional support required?
Yes. Evidence of institutional support is required, reflecting the expectation that the host organization(s) will back the infrastructure needed to run the clinical trial.
What are the IND requirements for investigational drugs?
If the trial involves a drug that is not FDA-approved for the proposed investigational use, the application must include evidence that an Investigational New Drug (IND) submission has been made or will be made within 60 days of award.
What are the IDE requirements for investigational devices?
For devices, similar expectations apply for an Investigational Device Exemption (IDE), including the option to document exemption where applicable.
What happens if IND or IDE requirements are not met on time?
The government reserves the right to withdraw funding if the IND or IDE is not submitted within 60 days of the award date or if documented status is not obtained within six months.
What is the Funding Opportunity Number for this CTA?
The Funding Opportunity Number is W81XWH-13-GWIRP-CTA-MPIO.
What type of funding instrument is used?
The opportunity is listed as a discretionary program using a cooperative agreement/grant structure.
What is the CFDA number associated with this opportunity?
The CFDA number is 12.420 (Military Medical Research and Development).
When was this opportunity posted and when did it close?
It was posted on July 11, 2013, and the closing date was November 25, 2013.
How many awards were anticipated and what was the estimated total funding level?
Approximately three awards were anticipated, with an estimated total funding level of $9.6 million.
Who is eligible to apply?
Eligibility is described as unrestricted (open to any type of entity), subject to any additional eligibility clarifications in the full announcement.
Is cost-sharing or matching required?
No cost-sharing or matching requirement is stated in the provided information.
Who can applicants contact for help accessing the full announcement?
Applicants needing assistance accessing the full announcement can contact the CDMRP Help Desk at 301-682-5507.
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