DOD Gulf War Illness Clinical Trial Award — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

DOD Gulf War Illness Clinical Trial Award

The FY09 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...

76
match
Award $0 Deadline 6128 days ago Location Alabama Type grant Level Federal Closed posted Apr 21, 2009
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$1,200,000.
  • Next deadline: September 9, 2009.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
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The “key facts” mode pulls structured fields directly from the official source posting (amount, deadline, eligibility tags). The AI mode adds a short plain-English narrative on top, generated from the same source. Always verify with the agency before applying.

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Award amount
$0
Deadline
6128 days ago
Sep 9, 2009
Total pool
$1.2M

About this opportunity

The FY09 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 is intended to support larger, more definitive (Phase II-III) clinical trials of studies where preliminary and preclinical evidence indicates the potential for substantial benefit for veterans with GWI. 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/ The GWIRP Clinical Trial Award mechanism is being offered for the second time in FY09. The CTA supports rapid execution of clinical trials with the potential to have a significant impact on the health and lives of veterans with GWI. The GWIRP seeks proposals that will contribute to identification of effective interventions for GWI. This will include larger, more definitive clinical trials of studies where preliminary and preclinical evidence indicates the potential for substantial benefit for veterans with GWI. Health outcomes of interest include effects of interventions on: • Global health measures, functional status DOD Gulf War Illness Research Program Clinical Trial Award 3 • Symptom complexes ( cognitive function, musculoskeletal/pain symptoms, gastrointestinal problems, skin abnormalities) individually and as they may interact with each other • Measurable clinical outcomes, biomarkers • GWI subgroups characterized by symptom or other clinical characteristics Methods used to identify GWI cases and GWI patient subgroups of interest, health status, and treatment outcomes must be clearly described. Assessed outcomes should include global changes in health status, specific objective measures, where applicable, and changes in symptom domains of interest ( pain, cognitive function, gastrointestinal problems, sleep function). Proposals are required to include preliminary data, but it does not necessarily have to come from the GWI research field. Each application should contain only one clinical trial with a distinct study design. PIs are encouraged to pursue correlative studies that accompany their trials. PIs conducting correlative studies must describe in detail the study aims, procedures or methods, and plans for data management and analysis, including an appropriately powered statistical plan. Funding from this award mechanism cannot be used for preclinical research studies. It is expected that the device to be used in the proposed trial will be available in sufficient quantities and ready for clinical trials at the time that the award is made. Principal Investigators (PIs) must clearly specify in the Clinical Protocol (main body of the application) which type of clinical trial is being proposed: Phase II or Phase III. For descriptions of each type of clinical trial, please refer to http://www.fda.gov/cder/guidance/6384dft.htm and http:// Or, refer to the Application Instructions and General Information, Appendix 6, for helpful information about distinguishing clinical trials and clinical research. Further, it is expected that the clinical trial will be initiated within 12 months of the award date. Important aspects of the Clinical Trial Award are: • A study protocol will be the main body of the application. The protocol must be reviewed by the Principal Investigator’s Institutional Review Board (IRB), the US Army Medical Research and Materiel Command (USAMRMC), and other regulatory agencies as needed. NOTE: Local IRB approval at the time of submission is NOT required.

Funding agency

Defense Health Agency Contracting Activity - DHACA
Federal agency

Tags

Healthcare & Biotech Arts & Culture Education & Research Veterans Transportation & Logistics
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Who can apply

Eligibility details aren't on file yet — check the agency source link in the Documents tab for the latest rules.

Geographic eligibility

  • Alabama
  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming
  • District of Columbia

How to apply

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Source documents

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Canonical NOFO, application packet, and forms
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Citation details

Source systemgrants.gov
Source ID46922
PostedApr 21, 2009

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