Description
The FY09 GWIRP is offering two award mechanisms to evaluate potential interventions for Gulf War Illness: the Innovative Treatment Evaluation Award (ITEA) and the Clinical Trial Award (CTA). The ITEA described in this Program Announcement 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. [Note: All studies involving interventions, regardless of design, are considered clinical trials.] In contrast, the CTA supports proposals evaluating treatments of interventions in larger, more definitive clinical trials (Phase II or III), where preliminary and pre-clinical evidence indicates the potential for substantial benefit for veterans with GWI. Those interested in applying for the CTA mechanism should review the appropriate Program Announcement (http://cdmrp.army.mil/funding/gwirp.htm). The ITEA mechanism is being offered for the first time in FY09. The intent of the award is to provide support for the systematic evaluation of innovative treatment interventions not previously studied in Gulf War veterans, with the aim of improving their health and functional status. The results of preliminary studies funded by this award will support future development of larger efficacy studies of the proposed interventions. DOD GWIRP Innovative Treatment Evaluation Award 3 This award mechanism is intended to evaluate a broad scope of treatment approaches with potential for widespread, cost-effective application for GWI. Treatment approaches may include pharmacologic or other physiological interventions, including either conventional or complementary treatments, or combinations of these approaches. A variety of experimental and non-experimental study designs are acceptable under this award mechanism. The proposed study design will depend on the specific treatment or intervention to be assessed, resources available to clinical investigators, and the level of evidence currently available to support the proposed treatment for GWI. Examples of potential prospective designs may include systematic case series, prospective outcome evaluation studies, small-scale randomized trials, a combination of these, or other innovative prospective methods. Projects of interest include innovative treatment approaches currently in clinical use that have not been systematically evaluated for effectiveness in treating GWI but may have been evaluated in conditions with similarities to GWI. Also of interest are interventions based on biological alterations identified in veterans with GWI. Thus, the GWIRP will accept proposals not only for early pilot clinical trials supported by preliminary data but also for those based on sound scientific rationale without support from preliminary data. Important aspects of the Innovative Treatment Evaluation Award are: The GWIRP views an innovative proposal as one that studies a previously untested treatment for GWI, including treatments that have been utilized for other chronic multi-symptom illnesses, though not yet studied in ill GW veterans. For example, a pharmacological treatment or nutritional supplement suggested by previous research to be beneficial for fibromyalgia or chronic fatigue syndrome could be evaluated in veterans with GWI under the ITEA. However, the focus must be clearly on Gulf War Illness and not on another disease process. Preliminary data is allowed in this award but is not required, and the data does not necessarily need to come from Gulf War Illness research. If a proposal is submitted without preliminary data, the PI must provide a sound logical rationale to support potential effectiveness of the treatment in Gulf War Illness. Conversely, if there is significant preliminary and preclinical data reflecting considerable development of a treatment with applicability to GWI, the proposal would not be deemed innovative, in keeping with the intent of the ITEA. In these instances, investigators are encouraged to apply to the GWIRP Clinical Trial Award (CTA), which supports Phase II or Phase III clinical trials (http://cdmrp.army.mil/funding/gwirp.htm). The proposed study must have clearly defined and focused health outcome endpoints. Outcomes of interest may include improvement in functional status, reduction in symptoms, or differences in objective clinical or laboratory measures, where applicable. 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, and required clinical resources will be allotted. DOD GWIRP Innovative Treatment Evaluation Award 4 Investigational new drug (IND) approval applications, if applicable, should be submitted or completed before submission to the ITEA 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. It is expected that the treatment to be used in the proposed clinical trial will be available in sufficient quantities 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. 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, and must meet all regulatory approvals prior to initiation of the study. NOTE: Local IRB submission or approval at the time of submission to the ITEA is NOT required. Studies whose principal focus is on treatment of psychiatric conditions 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). Proposals including retrospective or non-interventional study designs are not considered clinical trials and should be submitted to the FY09 GWIRP Investigator-Initiated Research Award.(cdmrp.army.mil/funding/gwirp). Funding from this award mechanism cannot be used for preclinical research studies, studies demonstrating pharmacokinetics/pharmacodynamics or safety only (Phase 0, Phase I studies). For descriptions of each type of clinical trial, please refer to www.fda.gov/cder/guidance/6384dft.htm, http://www.clinicaltrials.gov, or the NIH PH398 Instructions (p.III-25).