OpportunityTitle: DoD FY11 Gulf War Illness Clinical Trial Award
Description: 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/gwirp.shtml.) 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: &#239;&#191;&#189; Global health measures (biomarkers) and/or functional status &#239;&#191;&#189; Improvements in symptom complexes (e.g., cognitive function, musculoskeletal/pain symptoms, gastrointestinal symptoms, fatigue, respiratory problems, skin abnormalities, sleep difficulties) individually and as they may interact with each other &#239;&#191;&#189; 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&#239;&#191;&#189;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&#239;&#191;&#189; 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 (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, 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. The term &#239;&#191;&#189;human subjects&#239;&#191;&#189; is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. PIs must clearly specify which type of clinical trial is being proposed: Phase II or Phase III for drug trials, Class I-III for device trials, or description of behavioral/epidemiological trials. For descriptions of each type of clinical trial, please refer to the FDA 21CFR 312.21 (link), www.clinicaltrials.gov, or the NIH PH398 Instructions (p.III-26). For more information on clinical research, a Human Subject Resource Document is provided at https://cdmrp.org/Program_Announcements_and_Forms. Retrospective or non-interventional study designs are not considered clinical trials and should be submitted to the FY11 GWIRP Investigator-Initiated Research Award (see http://cdmrp.army.mil/funding/gwirp). If the study proposed involves the use of a drug that has not been approved by the Food and Drug Administration (FDA) for its investigational use then an Investigational New Drug (IND)application to the FDA may be required and must be submitted to the FDA prior to the grant submission. If the proposed study involves an Investigational Device that has not been approved or cleared by FDA for its investigational clinical use, the study may be required to comply with the FDA Investigational Device Exemption (IDE) regulations. If applicable, the IDE application must be submitted prior to the grant submission. The Government reserves the right to withdraw funding if the documented status of the IND or IDE has not been obtained within 6 months of the award date. The following are important aspects of submission for the CTA: &#239;&#191;&#189; The proposed clinical trial is expected to begin no later than 12 months after the award date. &#239;&#191;&#189; 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. &#239;&#191;&#189; PIs must demonstrate availability of and access to a suitable Gulf War veteran population that will support a meaningful outcome for the study. Discuss how accrual goals will be achieved, and how standards of care may impact the study population. PIs are encouraged to collaborate with an investigator who has demonstrated access to a population of ill and healthy Gulf War veterans, particularly investigators within the U.S. Department of Veterans Affairs. &#239;&#191;&#189; Clearly articulate the statistical analysis plan. Include a power analysis reflecting sample size projections that will clearly answer the objectives of the study. &#239;&#191;&#189; Discuss the potential impact of the study results for ill Gulf War veterans. &#239;&#191;&#189; Include a study coordinator(s) who will guide the clinical protocol through Institutional Review Board (IRB), and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate human subject accrual. &#239;&#191;&#189; Demonstrate institutional support.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: 301-682-5507