Opportunity Information: Apply for W81XWH 11 GWIRP CTA
Apply for W81XWH 11 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 FY11 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 27, 2011 and posted on Apr 27, 2011.
- Applicants must submit their applications by Aug 24, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,400,000.00 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 FY11 Gulf War Illness Clinical Trial Award (CTA) is a Congressionally Directed Medical Research Programs (CDMRP) funding opportunity run through the Department of the Army (USAMRAA) to support larger, more definitive clinical trials aimed at improving the health and daily functioning of veterans living with Gulf War Illness (GWI). This mechanism is specifically designed for trials that are beyond the early pilot stage, generally aligning with Phase II or Phase III drug trials and FDA device Class I through III studies, as well as appropriately defined behavioral intervention trials. The overarching goal is to fund well-developed interventions that are ready to be tested in human participants and that could meaningfully change clinical care or symptom management for ill Gulf War veterans.
A key feature of the FY11 Gulf War Illness Research Program (GWIRP) is that it offers two related but distinct pathways: the CTA and the Innovative Treatment Evaluation Award (ITEA). The CTA is the more advanced option and expects applicants to bring a stronger evidence base, while the ITEA is meant for earlier-stage or pilot clinical trials (Phase II or Phase I/II) and does not require preliminary data. In other words, CTA funding is meant for interventions that have already progressed far enough that a larger, more definitive trial is justified, whereas ITEA is intended for first-in-GWI or early feasibility testing. The CTA has been offered before (first in FY08), and the announcement notes a competitive history, with relatively few applications ultimately recommended for funding.
The CTA emphasizes outcomes that reflect the multi-symptom, multi-system nature of Gulf War Illness. Applicants are expected to focus on health outcomes such as global health measures, including biomarkers and/or functional status, and on improvements across common GWI symptom complexes. These symptom domains include cognitive problems, musculoskeletal and pain symptoms, gastrointestinal issues, fatigue, respiratory problems, skin abnormalities, and sleep difficulties. The program also encourages attention to how symptom clusters may interact rather than treating each symptom in isolation, and it highlights interest in analyses of GWI subgroups defined by symptom patterns or other clinical characteristics. At the same time, the program draws clear boundaries around what it will not support: proposals primarily focused on psychiatric conditions (including PTSD) are not eligible under this announcement, and research focused on amyotrophic lateral sclerosis (ALS) is also excluded because ALS is covered under a separate DoD program.
Because GWI case identification can vary, the announcement places strong requirements on how applicants define their study population. Investigators must clearly state how they will define GWI cases and any targeted subgroups, and they must cite a published case definition that recognizes GWI as a multi-symptom illness. The announcement points applicants to the 2008 Research Advisory Committee on Gulf War Veterans Illnesses report for background on case definitions and prior treatment research, signaling that reviewers will expect applicants to show they understand the existing evidence and controversies around diagnosis and prior intervention studies.
From a readiness and rigor standpoint, the CTA requires preliminary data, although those data do not have to come directly from prior GWI studies. What matters is that the proposal is supported by a solid scientific rationale grounded in critical review of the literature and evidence that the intervention is sufficiently developed. The award cannot be used for preclinical research; it must directly support a clinical trial as defined in the announcement, meaning prospective enrollment of human subjects and testing an intervention (drug, device, biologic, procedure, rehabilitative or behavioral modality, or similar) with measurable outcomes related to safety, effectiveness, and/or efficacy. Retrospective analyses and non-interventional designs are explicitly excluded from the CTA and are directed instead to another GWIRP mechanism (the Investigator-Initiated Research Award).
Regulatory and operational expectations are spelled out in a way that signals the DoD wants trials that can start quickly and run smoothly. Applicants must specify the clinical trial type (Phase II or Phase III for drugs; Class I to III for devices; or clearly described behavioral/other trial types), and they are responsible for meeting FDA requirements where applicable. If an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) is required, it must be submitted to the FDA before the grant submission, and the government can withdraw funding if proof of IND/IDE status is not obtained within six months of the award date. The trial is expected to begin no later than 12 months after award, and applicants are expected to have the intervention, drug, or device available in sufficient quantities and ready to deploy at the time of award, reinforcing that this mechanism is not meant for early development work.
The announcement also stresses feasibility in recruitment and study execution. Principal Investigators have to demonstrate access to a suitable Gulf War veteran population large enough to achieve meaningful outcomes, including a clear plan for meeting accrual goals and an explanation of how standards of care could affect recruitment or retention. Collaboration with investigators who have established access to ill and healthy Gulf War veteran cohorts, particularly within the U.S. Department of Veterans Affairs, is encouraged. Methodologically, applicants must provide a clearly articulated statistical analysis plan and include a power analysis tied to the study objectives and projected sample size. Operationally, they are expected to include study coordinator support to manage IRB and other regulatory approvals, multi-site coordination if relevant, and participant accrual, along with evidence of institutional support.
Administratively, this is a discretionary funding opportunity offered as a cooperative agreement or grant under CFDA 12.420 (Military Medical Research and Development). The opportunity number is W81XWH-11-GWIRP-CTA. In FY11, the program anticipated making about two awards with an estimated total funding pool of $2.4 million, with no cost sharing or matching requirement and broad eligibility (open to any entity type, unless otherwise clarified in the full announcement). The opportunity was posted April 27, 2011, with an application deadline of August 24, 2011, and an archive date of September 23, 2011. For access issues, the announcement provides a CDMRP help desk contact number (301-682-5507).
FAQs: DoD FY11 Gulf War Illness Clinical Trial Award (CTA)
1) What is the DoD FY11 Gulf War Illness Clinical Trial Award (CTA)?
The CTA is a funding opportunity under the Congressionally Directed Medical Research Programs (CDMRP), managed through the Department of the Army (USAMRAA). It is intended to support larger, more definitive clinical trials designed to improve the health and daily functioning of veterans living with Gulf War Illness (GWI).
2) What is the main purpose of this award mechanism?
The purpose is to fund well-developed interventions that are ready to be tested in human participants in a clinical trial setting and that could meaningfully influence clinical care or symptom management for ill Gulf War veterans.
3) How is the CTA different from the Innovative Treatment Evaluation Award (ITEA)?
The FY11 GWIRP includes two related pathways: CTA and ITEA. The CTA is meant for more advanced trials and expects a stronger evidence base and preliminary data. The ITEA is intended for earlier-stage or pilot trials (Phase II or Phase I/II) and does not require preliminary data.
4) What stage of clinical trial is the CTA designed to support?
The CTA generally aligns with trials beyond the early pilot stage, such as Phase II or Phase III drug trials and FDA device studies for Class I through Class III devices. It may also support appropriately defined behavioral intervention trials, as long as they are well-developed and ready for more definitive testing.
5) Are pilot or first-in-GWI trials a fit for the CTA?
The CTA is positioned as the more advanced option. Earlier-stage, pilot, or first-in-GWI feasibility testing is more aligned with the ITEA pathway described in the announcement.
6) What kinds of interventions can be tested under the CTA?
The announcement describes interventions such as drugs, devices, biologics, procedures, rehabilitative modalities, behavioral modalities, or similar interventions, provided they are tested prospectively in human subjects with measurable outcomes related to safety, effectiveness, and/or efficacy.
7) What does the program consider a clinical trial for this award?
A clinical trial is defined as prospective enrollment of human subjects to test an intervention with measurable outcomes related to safety, effectiveness, and/or efficacy. The CTA cannot be used for preclinical research.
8) Are retrospective studies or non-interventional studies allowed under the CTA?
No. Retrospective analyses and non-interventional designs are explicitly excluded from the CTA and are instead directed to another GWIRP mechanism (the Investigator-Initiated Research Award).
9) Is preclinical research eligible for CTA funding?
No. The award cannot be used for preclinical research. It must directly support a qualifying clinical trial.
10) What outcomes does the CTA emphasize for Gulf War Illness trials?
The CTA emphasizes outcomes that reflect the multi-symptom, multi-system nature of GWI. This includes global health measures (including biomarkers and/or functional status) and improvements across common GWI symptom complexes.
11) Which Gulf War Illness symptom domains are specifically highlighted?
The announcement highlights symptom domains including cognitive problems, musculoskeletal and pain symptoms, gastrointestinal issues, fatigue, respiratory problems, skin abnormalities, and sleep difficulties.
12) Does the program encourage looking at symptom clusters rather than isolated symptoms?
Yes. The program encourages attention to how symptom clusters may interact rather than treating each symptom in isolation.
13) Does the CTA encourage subgroup analyses?
Yes. The announcement notes interest in analyses of GWI subgroups defined by symptom patterns or other clinical characteristics.
14) Are studies primarily focused on psychiatric conditions eligible?
No. Proposals primarily focused on psychiatric conditions, including PTSD, are not eligible under this announcement.
15) Is ALS-focused research eligible under this CTA?
No. Research focused on amyotrophic lateral sclerosis (ALS) is excluded because ALS is covered under a separate DoD program.
16) How must applicants define Gulf War Illness cases for their study population?
Applicants must clearly state how they will define GWI cases and any targeted subgroups. They must cite a published case definition that recognizes GWI as a multi-symptom illness.
17) Does the announcement point to any specific resource on GWI case definitions?
Yes. The announcement points applicants to the 2008 Research Advisory Committee on Gulf War Veterans Illnesses report for background on case definitions and prior treatment research.
18) Are preliminary data required for the CTA?
Yes. The CTA requires preliminary data, although those data do not have to come directly from prior GWI studies.
19) Can preliminary data come from non-GWI studies?
Yes. The announcement indicates preliminary data do not need to be from prior GWI studies, as long as the proposal is supported by a solid scientific rationale grounded in a critical review of the literature and evidence that the intervention is sufficiently developed.
20) What clinical trial types must be specified in the application?
Applicants must specify the clinical trial type, such as Phase II or Phase III for drugs, Class I through Class III for devices, or clearly described behavioral or other trial types as appropriate.
21) What FDA regulatory requirements may apply to projects funded under the CTA?
Applicants are responsible for meeting FDA requirements where applicable. If an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) is required, it must be submitted to the FDA before the grant submission.
22) What happens if IND/IDE proof is not obtained after award?
The announcement states that the government can withdraw funding if proof of IND/IDE status is not obtained within six months of the award date.
23) How quickly is the trial expected to begin after award?
The trial is expected to begin no later than 12 months after the award.
24) Does the intervention need to be ready to deploy at the time of award?
Yes. Applicants are expected to have the intervention, drug, or device available in sufficient quantities and ready to deploy at the time of award, indicating the CTA is not meant for early development work.
25) What recruitment feasibility expectations are described?
The Principal Investigator must demonstrate access to a suitable Gulf War veteran population large enough to achieve meaningful outcomes. The application must include a clear plan for meeting accrual goals and explain how standards of care could affect recruitment or retention.
26) Is collaboration with the U.S. Department of Veterans Affairs encouraged?
Yes. Collaboration with investigators who have established access to ill and healthy Gulf War veteran cohorts, particularly within the U.S. Department of Veterans Affairs, is encouraged.
27) What statistical planning is required?
Applicants must provide a clearly articulated statistical analysis plan and include a power analysis tied to the study objectives and projected sample size.
28) What operational or staffing support does the announcement expect?
The announcement expects study coordinator support to help manage IRB and other regulatory approvals, multi-site coordination if relevant, and participant accrual, along with evidence of institutional support.
29) What kind of funding instrument is used for this opportunity?
The opportunity is offered as a cooperative agreement or grant.
30) What is the CFDA number for this program?
The CFDA number listed is 12.420 (Military Medical Research and Development).
31) What is the opportunity number for the FY11 CTA?
The opportunity number is W81XWH-11-GWIRP-CTA.
32) How many awards and how much total funding were anticipated in FY11?
The program anticipated making about two awards with an estimated total funding pool of $2.4 million.
33) Is cost sharing or matching required?
No. The announcement indicates there is no cost sharing or matching requirement.
34) Who is eligible to apply?
The information provided indicates broad eligibility and states it is open to any entity type, unless otherwise clarified in the full announcement.
35) When was this opportunity posted and what were the key dates?
It was posted on April 27, 2011. The application deadline was August 24, 2011, and the archive date was September 23, 2011.
36) Was the CTA offered in prior years?
Yes. The CTA had been offered previously, first in FY08.
37) How competitive is this CTA mechanism?
The announcement notes a competitive history, with relatively few applications ultimately recommended for funding.
38) Where can applicants get help if they have access issues?
The announcement provides a CDMRP help desk contact number for access issues: 301-682-5507.
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