DOD Gulf War Illness Research Program Clinical Trial Award

The summary for the DOD Gulf War Illness Research Program Clinical Trial Award grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Dept of the Army USAMRAA, which is the U.S. government agency offering this grant.

DOD Gulf War Illness Research Program Clinical Trial Award: The GWIRP Clinical Trial Award mechanism is being offered for the first time in FY08. The Clinical Trial Award supports rapid execution of clinical trials with the potential to have a significant impact on the health and lives of veterans with GWI.Although the GWIRP seeks proposals from many areas of research that will further its goal of improving the health and lives of veterans who have GWI, particular areas of interest are:. Endocrine system. Infectious disease. Neurology. Neuroimmunology. Immunology. Autocrine system. BiomarkersThe GWIRP also wishes to encourage proposals that deal directly with the particular symptom subgroups listed below and their potential interaction with each other:. Fatigue. Cognitive function. Gastrointestinal/autonomic nervous system. Musculoskeletal/pain. Skin. Respiratory systemMethods used to identify GWI cases and GWI patient subgroups of interest, health status, and treatment outcomes must be clearly described. Assessed treatment outcomes should include global changes in health status, specific objective measures where applicable, and changes in symptom domains of interest (e.g., pain, cognitive function, gastrointestinal problems, sleep difficulties, abnormalities, fatigue, respiratory function). Proposals are required to include preliminary data, but it does not necessarily have to come from the GWI research field. Each proposal must include only one clinical trial. 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.It is expected that the intervention, drug, or 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. Further, it is expected that the clinical trial will be initiated within 12 months of the award date. Note that Investigational New Drug (IND)/Investigational Device Exemption (IDE) approvals, if applicable, should be in process or completed before submission of an application to this mechanism. If IND/IDE approval is not received by April 30, 2009, the Government reserves the right to not fund the award. Funding from this award mechanism cannot be used for preclinical research studies. Important aspects of the Clinical Trial Award are:. The protocol must include a named study coordinator who will guide the protocol through local institutional review board (IRB), US Army Medical Research and Materiel Command (USAMRMC), and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate volunteer accrual.. IND or IDE approvals, if applicable, should be in process or completed before submission of the proposal to the Clinical Trial Award mechanism. If IND/IDE approval is not received by April 30, 2009, the Government reserves the right to not fund the award.. The clinical trial should have a potentially high impact.. The clinical trial must have clearly defined and appropriate endpoints.. Proposals must clearly indicate how accrual goals will be achieved.Please note that all DOD-funded research involving human subjects and human biological substances must be reviewed and approved by the USAMRMCs Office of Research Protections, Human Research Protection Office (HRPO) in addition to local IRBs. The HRPO is mandated to comply with specific laws and directives governing all research involving human subjects that is conducted or supported by the DOD. These laws and directives are rigorous and detailed and will require information in addition to that supplied to the local review board. Allow a minimum of 6 months for regulatory review and approval processes for studies involving human subjects.Studies whose principal focus is on treatment of psychiatric conditions will not be funded under this Program Announcement/Funding Opportunity.For further information about GWI and the intent of this award, see the Information Paper at http://cdmrp.army.mil/funding/pdf/08gwirpinfopaper.pdf. See the Program Announcement for the full Funding Opportunity Description.