DoD FY11 Gulf War Illness Innovative Treatment Evaluation Award | Apply Online

Opportunity Summary:

The DoD FY11 Gulf War Illness Innovative Treatment Evaluation Award (ITEA) is a Gulf War Illness Research Program (GWIRP) funding opportunity run through the Congressionally Directed Medical Research Programs (CDMRP) to support early, systematic testing of promising treatments for Gulf War Illness (GWI) in human subjects. The program is built around the idea that many potentially helpful interventions have not yet been tried in ill Gulf War veterans, and that small, well-designed early phase trials can generate proof-of-principle evidence to justify larger, more definitive studies later. In FY11, GWIRP offered two related clinical-trial mechanisms: the ITEA for smaller, earlier-stage evaluations and the separate Clinical Trial Award (CTA) for larger Phase II/III trials when substantial preliminary and preclinical evidence already exists.

ITEA specifically targets early phase or pilot clinical trials, generally Phase II or Phase I/II for drugs and FDA device Classes I through III for devices, and it explicitly does not require preliminary data. Innovation is a central expectation: proposals can be innovative by testing a novel approach for GWI, or by adapting an intervention that has been used or studied in related chronic multi-symptom illnesses (such as fibromyalgia or chronic fatigue syndrome) but has not been evaluated in Gulf War veterans with GWI. Even when borrowing from another field, the research has to remain clearly centered on GWI rather than shifting the focus to another disease. The award is meant to accommodate a broad range of treatment approaches, including conventional pharmacologic or physiological interventions, complementary approaches, and combination strategies, as long as they are tested prospectively in a clinical trial framework.

A wide variety of prospective study designs are allowed, reflecting the pilot nature of the mechanism. Examples called out include systematic case series, prospective outcome evaluations, small randomized trials, hybrids of these approaches, and other creative prospective methods suitable for early testing. Interventions grounded in biological alterations observed in veterans with GWI are also encouraged. Importantly, the announcement treats all intervention studies as clinical trials regardless of whether the design is randomized, and it draws a bright line excluding retrospective or non-interventional work from this mechanism (those belong under other GWIRP funding options). Funding under ITEA must support a clinical trial and cannot be used for preclinical research.

The outcomes the program wants investigators to measure include changes in global health (including biomarkers) and/or functional status, as well as improvements across the symptom complexes commonly seen in GWI. The announcement highlights cognitive issues, musculoskeletal pain, gastrointestinal symptoms, fatigue, respiratory problems, skin abnormalities, and sleep difficulties, and it emphasizes that these symptoms may interact with each other. The program is also interested in analyses that consider GWI subgroups defined by symptom patterns or other clinical characteristics, which reflects the multi-symptom, heterogeneous nature of the illness.

There are clear topic boundaries. Projects focused primarily on treatment of psychiatric conditions, including PTSD, are not eligible for funding under this announcement. The program also will not accept proposals focused on ALS, even though Gulf War veterans have elevated ALS rates; ALS work is directed to a separate FY11 ALS Research Program. For eligibility within GWI, applicants must clearly define what constitutes a GWI case for the study and must cite a published case definition that recognizes the multisymptom nature of GWI. The announcement points investigators to the 2008 Research Advisory Committee on Gulf War Veterans Illnesses report for background on case definitions and prior treatment research.

From an execution and readiness standpoint, the DoD signals that this mechanism is intended for trials that can get moving quickly and recruit the right population. Trials are expected to begin within 12 months of the award date, and the intervention (drug or device) should already be available in sufficient quantity and be ready for clinical use in the proposed trial at the time of award. Applicants must demonstrate access to an appropriate Gulf War veteran population and provide a credible accrual plan, including how enrollment targets will be met and how standards of care could affect recruitment. Collaboration with investigators who have established access to ill and healthy Gulf War veterans, particularly within the U.S. Department of Veterans Affairs, is encouraged. Applications are also expected to include a clear statistical analysis plan and a power analysis tied to the study objectives, along with a discussion of potential impact for ill Gulf War veterans. Operationally, the program expects a study coordinator to manage IRB and regulatory processes, coordinate multi-site activities if applicable, and support participant accrual, and it also requires evidence of institutional support.

Regulatory expectations are spelled out for investigational products. If the trial uses a drug not approved by the FDA for the proposed investigational use, an IND may be required and must be submitted to the FDA prior to grant submission. If the trial uses an investigational device not approved or cleared for the proposed clinical use, IDE requirements may apply and an IDE submission must be made prior to grant submission. The government reserves the right to withdraw funding if documentation of IND or IDE status is not obtained within 6 months of the award date.

Administratively, this opportunity (Funding Opportunity Number W81XWH-11-GWIRP-ITEA) was posted April 27, 2011, with an application deadline of August 24, 2011, and an archive date of September 23, 2011. It is a discretionary research and development funding opportunity offered by the Department of the Army (USAMRAA/CDMRP) using a grant/cooperative agreement instrument type. Eligibility is listed as unrestricted (open to any entity type, subject to any additional eligibility language in the full announcement). The program anticipated making about two awards, with an estimated total funding amount of $1,440,000, and it did not require cost sharing or matching.

Browse more opportunities from the same agency: Dept. of the Army USAMRAA

Browse more opportunities from the same category: Science and Technology and other Research and Development

Next opportunity: National Child Traumatic Stress Initiative Combined RFA Treatment and Service Adaptation Centers Category II and the Community Treatment and Services Centers Category III

Previous opportunity: DoD FY11 Gulf War Illness Clinical Trial 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 11 GWIRP ITEA

 

[Watch] how do funding administrators access proposals?

Applicants also applied for:

Applicants who have applied for this opportunity (W81XWH 11 GWIRP ITEA) also looked into and applied for these:

 

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 11 GWIRP ITEA", 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.