Defense Health Agency Contracting Activity - DHACA
· Federal agency
DoD Gulf War Illness Innovative Treatment Evaluation Award
The FY14 GWIRP is offering two award mechanisms to evaluate potential interventions for Gulf War Illness: the Innovative Treatment Evaluation Award (ITEA) and the Clinical Trial Award (CTA). The ITEA described in this Pr...
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Award$0Deadline4286 days agoLocationAlabamaTypegrantLevelFederalClosedposted May 7, 2014
✦ AI Summary
Who can apply: Federal-level applicants (see eligibility for details).
Funding amount: total funding pool ~$4,100,000.
Next deadline: September 25, 2014.
Issued by: Defense Health Agency Contracting Activity - DHACA.
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Award amount
$0
Deadline
4286 days ago
Sep 25, 2014
Total pool
$4.1M
About this opportunity
The FY14 GWIRP is offering two award mechanisms to evaluate potential interventions for Gulf War Illness: the Innovative Treatment Evaluation Award (ITEA) and the Clinical Trial Award (CTA). The ITEA 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 0, I, or I/II, devices in Food and Drug Administration Class I-III) and does not require preliminary data in a Gulf War Illness model system. In contrast, the FY14 GWIRP Clinical Trial Award supports the evaluation of interventions in larger, more definitive clinical trials (Phase II or III), where preliminary and preclinical 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, 29 ITEA applications have been received, and 10 have been recommended for funding. The ITEA supports the early systematic evaluation of innovative interventions with the potential to impact the health and lives of veterans with GWI. The results of preliminary studies funded by this award should have the potential to provide clinical 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 veterans with GWI. 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. Given the emphasis on innovation in the ITEA, applications are not required to include preliminary data. If preliminary data are provided, the data do not necessarily have to come from the GWI research field. Whether or not preliminary data are included in the application, the proposed research project should be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature. If there is significant preliminary and preclinical data reflecting considerable development of a treatment with applicability to GWI, the application would not be deemed innovative in keeping with the intent of the ITEA. In this case, investigators are encouraged to apply to the GWIRP Clinical Trial Award, which supports Phase II or Phase III clinical trials (http://cdmrp.army.mil/funding/gwirp.shtml). This award mechanism is designed to evaluate a broad scope of treatment approaches with potential for application for GWI. Treatment approaches may include pharmacologic or other physiological interventions, including complementary (combination of alternative and conventional) 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.
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