Description
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/funding.htm.) 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 (e.g., cognitive function, musculoskeletal/pain symptoms, gastrointestinal symptoms, fatigue, respiratory 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 (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 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 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. 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://www.clinicaltrials.gov. 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 Investigators 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. The protocol must include a named study coordinator who will guide the study through local IRB, USAMRMC, and other regulatory approval processes, coordinates activities from all sites participating in the trial, and coordinates volunteer accrual. The clinical trial should have a potentially high impact. The focus must be clearly on Gulf War Illness and not on another disease process. Investigational new drug (IND) approvals, if applicable, should be initiated or completed before submission to the Clinical Trial Award mechanism. If IND/IDE (investigational device exemption) approval is not received within 6 months following the award date, the Government reserves the right to revoke funding. DOD Gulf War Illness Research Program Clinical Trial Award 4 The clinical trial must have clearly defined and focused endpoints that correspond to the design and sample size proposed. Proposals must clearly indicate how Gulf War Illness cases, including any targeted illness subgroup, will be defined for purposes of the study. Proposals must clearly indicate how the population of GW veterans will be accessed, accrual goals will be achieved, required clinical resources will be allotted, and how standards of care may impact the population under study. Demonstrate institutional support. Preliminary data is required for this award, although the data does not necessarily need to come from Gulf War Illness research. 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 award. In these instances, investigators are encouraged to submit to the GWIRP Innovative Treatment Evaluation Award (ITEA) that supports smaller pilot Phase II or Phase I/II combined clinical trials (http://cdmrp.army.mil/funding.). Studies whose principal focus is on treatment of psychiatric conditions, including PTSD, will not be funded under this Program Announcement/Funding Opportunity. While Gulf War veterans are affected by Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrigs 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 CDMRP is offering a separate ALS Research Program in FY 09 (see http://cdmrp.army.mil).