Defense Health Agency Contracting Activity - DHACA
· Federal agency
DoD FY11 Gulf War Illness Innovative Treatment Evaluation Award
The FY11 GWIRP is offering two award mechanisms to evaluate potential interventions for Gulf War Illness: the Clinical Trial Award (CTA) and the Innovative Treatment Evaluation Award (ITEA). The Innovative Treatment Eval...
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Award$0Deadline5414 days agoLocationAlabamaTypegrantLevelFederalClosedposted Apr 27, 2011
✦ AI Summary
Who can apply: Federal-level applicants (see eligibility for details).
Funding amount: total funding pool ~$1,440,000.
Next deadline: August 24, 2011.
Issued by: Defense Health Agency Contracting Activity - DHACA.
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Award amount
$0
Deadline
5414 days ago
Aug 24, 2011
Total pool
$1.4M
About this opportunity
The FY11 GWIRP is offering two award mechanisms to evaluate potential interventions for Gulf War Illness: the Clinical Trial Award (CTA) and the Innovative Treatment Evaluation Award (ITEA). The Innovative Treatment Evaluation Award described in this Program Announcement/Funding Opportunity is intended to support the initial evaluation of a treatment or intervention in smaller, early phase or pilot clinical trials (Phase II or I/II, devices in FDA Class I-III), and does not require preliminary data. In contrast, the CTA supports the evaluation of interventions in larger, more definitive clinical trials (Phase II or III), where preliminary and pre-clinical evidence indicates the potential for substantial benefit for veterans with GWI. (For more information about the CTA, see http://cdmrp.army.mil/funding/gwirp.htm). The ITEA mechanism was first offered in FY09. Since then, 10 ITEA applications have been received, and 4 have been recommended for funding. The ITEA supports the early systematic evaluation of innovative treatment interventions with the potential to impact the health and lives of veterans with GWI. The results of preliminary studies funded by this award can provide proof of principle data, and support future development of broader efficacy studies of the proposed interventions. Innovation is an important component of the ITEA. An application may demonstrate innovation not only by investigating a novel therapeutic approach for GWI, but also by studying a treatment that may have been utilized for other chronic multi-symptom illnesses, but has not yet been studied in ill Gulf War veterans. For example, a pharmacological treatment or nutritional supplement suggested by previous research to be beneficial for fibromyalgia or chronic fatigue syndrome could be evaluated in veterans with GWI under the ITEA. However, the focus of the research must be clearly on GWI and not on another disease process. This award mechanism is designed to evaluate a broad scope of treatment approaches with potential for widespread application for GWI. Treatment approaches may include pharmacologic or other physiological interventions, including either conventional or complementary treatments, or combinations of these approaches. A variety of experimental and non-experimental study designs are acceptable under this award mechanism. The proposed study design will depend on the specific treatment or intervention to be assessed, resources available to clinical investigators, and the level of evidence currently available to support the proposed treatment for GWI. Examples of potential prospective designs may include systematic case series, prospective outcome evaluation studies, small-scale randomized trials, a combination of these, or other innovative prospective methods. Also of interest are interventions based on biological alterations identified in veterans with GWI. All studies involving interventions, regardless of design, are considered clinical trials. Health outcomes of interest for the proposed trial should include effects of interventions on: � Global health measures (biomarkers) and/or functional status � Improvements in symptom complexes ( cognitive function, musculoskeletal/pain symptoms, gastrointestinal problems, skin abnormalities, sleep difficulties) individually and as they may interact with each other � GWI subgroups characterized by symptom or other clinical characteristics Studies whose principal focus is on treatment of psychiatric conditions, including Post-Traumatic Stress Disorder (PTSD), will not be funded under this Program Announcement/Funding Opportunity. While Gulf War veterans are affected by Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig�s disease), at twice the rate of veterans who did not serve in the Gulf War, the GWIRP will not accept proposals focusing on ALS research.
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