Defense Health Agency Contracting Activity - DHACA
· Federal agency
DoD FY11 Gulf War Illness Clinical Trial 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 Clinical Trial Award desc...
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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 ~$2,400,000.
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
$2.4M
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 Clinical Trial Award described in this Program Announcement/Funding Opportunity is intended to support larger, more definitive (Phase II-III, FDA device class I-III) clinical trials. In contrast, the ITEA supports the initial evaluation of a treatment or intervention in smaller,early phase or pilot clinical trials (Phase II or I/II), and does not require preliminary data. (For information about the ITEA, see http://cdmrp.army.mil/funding/ The CTA mechanism was first offered in FY08. Since then, 8 CTA applications have been received, and 2 have been recommended for funding. The CTA supports execution of clinical trials with the potential to have a significant impact on the health and lives of veterans with GWI. Health outcomes of interest 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. The Office of the Congressionally Directed Medical Research Programs (CDMRP) is offering a separate ALS Research Program in FY11 (see http://cdmrp.army.mil/alsrp). Applications must clearly indicate how GWI cases, including any targeted illness subgroups, will be defined for purposes of the study. PIs must provide a published case definition they intend to use to define their GWI population. Any case definition must recognize the multi-symptom nature of GWI. NOTE: The 2008 report of the Research Advisory Committee on Gulf War Veterans� Illnesses, Gulf War Illness and the Health of Gulf War Veterans, provides information on GWI case definitions (pp. 29-30, p. 57), previous treatment research in Gulf War veterans (pp. 36-39), and treatment research related to other multi-symptom conditions (pp. 285-287). The report can be found online at: http://www1.va.gov/RAC-GWVI. Applications are required to include preliminary data, but these do not necessarily have to come from the GWI research field. The proposed research project should also be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature. If there are no preliminary and/or preclinical data reflecting considerable development of a treatment, the proposal would not be deemed in keeping with the intent of the CTA. In this case, investigators are encouraged to apply to the GWIRP ITEA that supports small pilot Phase II or Phase I/II combined clinical trials (http://cdmrp.army.mil/funding/gwirp). Funding from this award mechanism must support a clinical trial and cannot be used for preclinical research studies. A clinical trial is defined as a prospective accrual of human subjects where an intervention ( procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory , and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other award mechanisms/funding opportunities being offered.
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