Opportunity Information: Apply for W81XWH 12 GWIRP CTA
Apply for W81XWH 12 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 Mar 10, 2012 and posted on Mar 10, 2012.
- Applicants must submit their applications by Jul 24, 2012. (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 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The DOD Gulf War Illness Clinical Trial Award (CTA) is a Fiscal Year 2012 funding opportunity run through the Congressionally Directed Medical Research Programs (CDMRP) under the U.S. Army Medical Research Acquisition Activity (USAMRAA). Its purpose is to fund larger, more definitive clinical trials that test interventions intended to improve the health and day-to-day functioning of veterans living with Gulf War Illness (GWI). Compared with the program's other mechanism, the Innovative Treatment Evaluation Award (ITEA), which is designed for smaller early-phase or pilot studies and does not require preliminary data, the CTA is aimed at more mature interventions that are ready for rigorous testing, generally in Phase II or Phase III clinical trials or with FDA-regulated devices spanning Class I through Class III. The overall emphasis is on trials that could realistically change clinical practice or meaningfully improve outcomes for ill Gulf War veterans.
The CTA prioritizes measurable health impacts that reflect the multi-symptom nature of GWI. Applicants are expected to focus on outcomes such as global health measures (including biomarkers) and/or functional status, and to evaluate improvements across key symptom complexes that often cluster in GWI, including cognitive problems, musculoskeletal pain, gastrointestinal symptoms, fatigue, respiratory issues, skin abnormalities, and sleep difficulties. The program also encourages work that accounts for potential interactions among symptoms and that examines GWI subgroups defined by symptom patterns or other clinical characteristics, since GWI is not a single uniform presentation. At the same time, the announcement clearly excludes certain topics: studies primarily focused on treating psychiatric conditions (including PTSD) are not eligible under this mechanism, and applications focused on amyotrophic lateral sclerosis (ALS) are not accepted because ALS is handled through a separate DOD ALS Research Program.
A central requirement is that the study population must be defined using a published GWI case definition, and the application must explain exactly how cases (and any targeted subgroups) will be identified for the trial. The case definition used must reflect the multi-symptom character of GWI, and the announcement points investigators to background resources such as the 2008 Research Advisory Committee on Gulf War Veterans' Illnesses report, which discusses case definitions and prior treatment research. Unlike the ITEA, the CTA requires preliminary data. The preliminary evidence does not have to come specifically from prior GWI studies, but it must support a sound scientific rationale and demonstrate that the intervention is sufficiently developed to justify a larger, more definitive clinical trial. Funding under this mechanism is specifically for conducting the clinical trial itself and cannot be used for preclinical research.
The opportunity uses a cooperative agreement and defines a clinical trial as prospective enrollment of human subjects where an intervention (drug, device, biologic, procedure, rehabilitation modality, behavioral intervention, or similar) is tested for measurable outcomes related to safety, effectiveness, or efficacy. Applicants must be prepared for real-world trial execution expectations. The trial is expected to start within 12 months of the award date, and the intervention must be available and ready in sufficient quantities at the time of award. Applications must also demonstrate access to an appropriate Gulf War veteran population and present a credible recruitment and accrual plan, including discussion of how standards of care could affect enrollment. Collaboration with investigators who have proven access to ill and healthy Gulf War veteran populations is encouraged, especially partnerships within the U.S. Department of Veterans Affairs.
From a design and management standpoint, proposals are expected to include clearly defined endpoints, a detailed statistical analysis plan, appropriate statistical expertise, and a power analysis with sample size projections that can convincingly answer the trial objectives. The application should also identify study coordinator support to manage multi-site coordination, regulatory submissions, Institutional Review Board (IRB) processes, and participant accrual. Another key element is a Transition Plan describing how the intervention will move forward after the trial, whether into the next clinical phase and/or toward delivery to the ill Gulf War veteran community, including likely funding paths and resources. Evidence of institutional support is also expected, reflecting the scale and complexity of the trials the CTA is meant to fund.
Regulatory readiness is treated as a serious requirement. If the trial involves a drug not already FDA-approved for the proposed investigational use, an Investigational New Drug (IND) application must be submitted to the FDA within 60 days of award. If an investigational device is involved and requires an Investigational Device Exemption (IDE), that IDE submission is also due within 60 days of award. The government reserves the right to withdraw funding if the IND/IDE status is not determined within six months of the award date, which effectively means applicants need to plan for fast regulatory action and have the necessary documentation and project infrastructure in place.
Administratively, the opportunity is listed as Funding Opportunity Number W81XWH-12-GWIRP-CTA under CFDA 12.420 (Military Medical Research and Development). It was posted March 10, 2012, with a closing date of July 24, 2012, and an estimated total funding amount of $2.4 million with an expectation of one award. Eligibility is described as unrestricted (open to any entity type, subject to any additional clarifications in the full announcement). For access issues, the announcement directs applicants to the CDMRP Help Desk (301-682-5507).
FAQs: DOD Gulf War Illness Clinical Trial Award (CTA) - FY2012
What is the DOD Gulf War Illness Clinical Trial Award (CTA)?
The Gulf War Illness Clinical Trial Award (CTA) is a Fiscal Year 2012 funding opportunity from the U.S. Department of Defense (DOD), administered through the Congressionally Directed Medical Research Programs (CDMRP) under the U.S. Army Medical Research Acquisition Activity (USAMRAA). It is designed to fund larger, more definitive clinical trials evaluating interventions intended to improve the health and day-to-day functioning of veterans living with Gulf War Illness (GWI).
What is the main purpose of this award?
The CTA aims to support rigorous clinical trials (generally Phase II or Phase III) that test mature interventions with a realistic potential to change clinical practice or meaningfully improve outcomes for ill Gulf War veterans. The emphasis is on measurable, clinically meaningful health impacts that reflect the multi-symptom nature of GWI.
How is the CTA different from the Innovative Treatment Evaluation Award (ITEA)?
Compared with the ITEA mechanism, which is intended for smaller early-phase or pilot studies and does not require preliminary data, the CTA is intended for more mature interventions ready for definitive testing. The CTA requires preliminary data supporting the rationale and readiness of the intervention for a larger trial.
What types of clinical trials are expected under the CTA?
The opportunity supports larger, more definitive trials, typically Phase II or Phase III. The announcement also indicates it can include FDA-regulated devices spanning Class I through Class III, as long as the project meets the clinical trial and readiness expectations described in the opportunity.
How does the program define a clinical trial for this opportunity?
A clinical trial is defined as the prospective enrollment of human subjects where an intervention is tested for measurable outcomes related to safety, effectiveness, or efficacy. Interventions may include a drug, device, biologic, procedure, rehabilitation modality, behavioral intervention, or similar approach.
What health outcomes does the CTA prioritize?
The CTA prioritizes measurable outcomes that capture the multi-symptom nature of GWI. Applicants are expected to focus on outcomes such as global health measures (including biomarkers) and/or functional status, and to evaluate improvements across key symptom complexes often seen in GWI.
Which symptom complexes are specifically mentioned as relevant to Gulf War Illness in this opportunity?
The announcement highlights symptom complexes that often cluster in GWI, including cognitive problems, musculoskeletal pain, gastrointestinal symptoms, fatigue, respiratory issues, skin abnormalities, and sleep difficulties.
Does the program encourage looking at interactions among symptoms or subgroups of GWI?
Yes. The opportunity encourages approaches that account for potential interactions among symptoms and that examine GWI subgroups defined by symptom patterns or other clinical characteristics, acknowledging that GWI is not a single uniform presentation.
Are any topics or disease areas explicitly excluded?
Yes. Studies primarily focused on treating psychiatric conditions (including PTSD) are not eligible under this mechanism. Applications focused on amyotrophic lateral sclerosis (ALS) are also not accepted because ALS is addressed through a separate DOD ALS Research Program.
What case definition must be used to identify Gulf War Illness participants?
The study population must be defined using a published GWI case definition. The application must explain exactly how cases (and any targeted subgroups) will be identified for the trial. The case definition must reflect the multi-symptom character of GWI.
Are there any referenced resources for background on GWI case definitions and prior treatment research?
Yes. The announcement points investigators to background resources such as the 2008 Research Advisory Committee on Gulf War Veterans' Illnesses report, which discusses case definitions and prior treatment research.
Is preliminary data required for a CTA application?
Yes. Unlike the ITEA, the CTA requires preliminary data. The preliminary evidence does not need to come specifically from prior GWI studies, but it must support a sound scientific rationale and show that the intervention is sufficiently developed to justify a larger, more definitive clinical trial.
Can CTA funds be used for preclinical research?
No. Funding under this mechanism is specifically for conducting the clinical trial itself and cannot be used for preclinical research.
What does it mean that this is a cooperative agreement?
The opportunity uses a cooperative agreement funding instrument. (The announcement identifies it as a cooperative agreement but does not provide additional details in the summary provided.)
When must the clinical trial start after an award is made?
The trial is expected to start within 12 months of the award date, reflecting the expectation of operational readiness and timely execution.
Does the intervention need to be ready at the time of award?
Yes. The intervention must be available and ready in sufficient quantities at the time of award.
What are the expectations for recruitment and access to Gulf War veteran populations?
Applications must demonstrate access to an appropriate Gulf War veteran population and provide a credible recruitment and accrual plan. The plan should also discuss how standards of care could affect enrollment. Collaboration with investigators who have proven access to ill and healthy Gulf War veteran populations is encouraged, including partnerships within the U.S. Department of Veterans Affairs.
What trial design and statistical elements are expected in the application?
Proposals are expected to include clearly defined endpoints, a detailed statistical analysis plan, appropriate statistical expertise, and a power analysis with sample size projections sufficient to convincingly answer the trial objectives.
What project management and coordination support is expected?
The application should identify study coordinator support to manage multi-site coordination, regulatory submissions, Institutional Review Board (IRB) processes, and participant accrual.
What is the Transition Plan, and why is it required?
The application must include a Transition Plan describing how the intervention will move forward after the trial, whether into the next clinical phase and/or toward delivery to the ill Gulf War veteran community. The plan should describe likely funding paths and resources to support next steps.
Is evidence of institutional support required?
Yes. Evidence of institutional support is expected, reflecting the scale and complexity of the larger clinical trials that the CTA is intended to fund.
What are the IND requirements if the trial involves a drug not already FDA-approved for the proposed use?
If the trial involves a drug that is not already FDA-approved for the proposed investigational use, an Investigational New Drug (IND) application must be submitted to the FDA within 60 days of award.
What are the IDE requirements if the trial involves an investigational device?
If the trial involves an investigational device and an Investigational Device Exemption (IDE) is required, the IDE must be submitted within 60 days of award.
What happens if IND/IDE status is not determined in time?
The government reserves the right to withdraw funding if the IND/IDE status is not determined within six months of the award date. This creates a strong expectation that applicants plan for rapid regulatory action and have the needed documentation and project infrastructure in place.
What is the Funding Opportunity Number (FON) for this CTA?
The Funding Opportunity Number is W81XWH-12-GWIRP-CTA.
What is the CFDA number associated with this opportunity?
The opportunity is listed under CFDA 12.420 (Military Medical Research and Development).
When was this opportunity posted and when did it close?
It was posted on March 10, 2012, and had a closing date of July 24, 2012.
How much total funding was estimated, and how many awards were expected?
The estimated total funding amount was $2.4 million, with an expectation of one award.
Who was eligible to apply?
Eligibility is described as unrestricted (open to any entity type), subject to any additional clarifications in the full announcement.
Who should applicants contact for access issues?
For access issues, the announcement directs applicants to the CDMRP Help Desk at 301-682-5507.
Browse more opportunities from the same category: Science and Technology and other Research and Development
Next opportunity: FY 2012 Funding Opportunity Announcement for NGO programs benefiting Sri Lankan refugees in Tamil Nadu, India
Previous opportunity: DOD Gulf War Illness Innovative Treatment Evaluation Award
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for W81XWH 12 GWIRP CTA
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (W81XWH 12 GWIRP CTA) also looked into and applied for these:
| Funding Opportunity |
|---|
| University Small Grants Broad Agency Announcement Apply for BAA RDK 2012 0001 Funding Number: BAA RDK 2012 0001 Agency: Air Force Research Lab Category: Science and Technology and other Research and Development Funding Amount: $100,000 |
| Arctic SEES Apply for 12 553 Funding Number: 12 553 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: $2,000,000 |
| Design and Construction of Regional Class Research Vessels (RCRV) Apply for 12 558 Funding Number: 12 558 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Energy for Sustainability Apply for PD 13 7644 Funding Number: PD 13 7644 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| NOTICE OF INTENT TO RELEASE A SOLICITATION FOR NASA JUPITER ICY MOONS EXPLORER INVESTIGATIONS Apply for NNH12ZDA010J Funding Number: NNH12ZDA010J Agency: NASA Headquarters Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| ADVANCE Increasing the Participation and Advancement of Women in Academic Science and Engineering Careers Apply for 12 584 Funding Number: 12 584 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: $4,000,000 |
| Computational and Data Enabled Science and Engineering Apply for PD 12 8084 Funding Number: PD 12 8084 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Software Infrastructure for Sustained Innovation S2I2 Apply for 13 511 Funding Number: 13 511 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Special Program Announcement for the Office of Naval Research Research Opportunity Text Analytics for Data to Decisions (D2D) Apply for 13 SN 0002 Funding Number: 13 SN 0002 Agency: Office of Naval Research Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Software Infrastructure for Sustained Innovation SSE SSI Apply for 13 525 Funding Number: 13 525 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: $5,000,000 |
| Asia Pacific Technology and Education Program Apply for ONRFOA13 006 Funding Number: ONRFOA13 006 Agency: Office of Naval Research Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| High Performance System Acquisition Building a More Inclusive Computing Environment for Science and Engineering Apply for 13 528 Funding Number: 13 528 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Prostate Cancer Biomarker Development Award Apply for W81XWH 13 PCRP BDA Funding Number: W81XWH 13 PCRP BDA Agency: Dept. of the Army USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Gulf War Illness Innovative Treatment Evaluation Award Apply for W81XWH 13 GWIRP ITEA Funding Number: W81XWH 13 GWIRP ITEA Agency: Dept. of the Army USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Gulf War Illness Clinical Trial Award Apply for W81XWH 13 GWIRP CTA Funding Number: W81XWH 13 GWIRP CTA Agency: Dept. of the Army USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Prostate Cancer Clinical Consortium Award Apply for W81XWH 13 PCRP CCA Funding Number: W81XWH 13 PCRP CCA Agency: Dept. of the Army USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Gulf War Illness Clinical Trial Award with Multiple PI Option Apply for W81XWH 13 GWIRP CTA MPIO Funding Number: W81XWH 13 GWIRP CTA MPIO Agency: Dept. of the Army USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Basic Research in Spatial Sensing Scene Characterization (also known as Imaging) Technology Apply for ONRBAA13 021 Funding Number: ONRBAA13 021 Agency: Office of Naval Research Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| NASA Innovative Advanced Concepts (NIAC) Apply for NNH14ZOA001N 14NIAC Funding Number: NNH14ZOA001N 14NIAC Agency: NASA Headquarters Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Software Infrastructure for Sustained Innovation SSE SSI Apply for 14 520 Funding Number: 14 520 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: $5,000,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "W81XWH 12 GWIRP CTA", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.