OpportunityTitle: Gulf War Illness Innovative Treatment Evaluation Award
Description: The Innovative Treatment Evaluation Award (ITEA) is intended to support the initial evaluation of a treatment or intervention in smaller, early phase or pilot clinical trials (Phase 0, I, or I/II, devices in U.S. Food and Drug Administration [FDA] Class I-III) and does not require preliminary data in a Gulf War Illness model system. The ITEA mechanism was first offered in FY09. Since then, 29 ITEA applications have been received, and 10 have been recommended for funding. The ITEA supports the early systematic evaluation of innovative interventions with the potential to impact the health and lives of veterans with GWI. The results of preliminary studies funded by this award should have the potential to provide clinical proof-of-principle data and support future development of broader efficacy studies of the proposed interventions. Innovation is an important component of the ITEA. An application may demonstrate innovation not only by investigating a novel therapeutic approach for GWI, but also by studying a treatment that may have been utilized for other chronic multi-symptom illnesses, but has not yet been studied in veterans with GWI. 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 of the research must be clearly on GWI (and veterans of the 1990-1991 Gulf War) and not on another disease process or veteran cohort. Given the emphasis on innovation in the ITEA, applications are not required to include preliminary data. If preliminary data are provided, the data do not necessarily have to come from the GWI research field. Whether or not preliminary data are included in the application, the proposed research project should be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature. If there is significant preliminary and preclinical data reflecting considerable development of a treatment with applicability to GWI, the application would not be deemed innovative in keeping with the intent of the ITEA. This award mechanism is designed to evaluate a broad scope of treatment approaches with potential for application for GWI. Treatment approaches may include pharmacologic or other physiological interventions, including conventional, alternative, or complementary (combination of alternative and conventional) 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. Also of interest are interventions based on biological alterations identified in veterans with GWI. All studies involving interventions, regardless of design, are considered clinical trials. Health outcomes of interest for the proposed trial should include effects of interventions on: &#149; Global health measures (biomarkers) and/or functional status; &#149; 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; &#149; GWI subgroups characterized by symptom or other clinical characteristics. Applications that include partnerships with the biotechnology or pharmaceutical industry that will leverage drug development efforts and accelerate the implementation of interventions for GWI are encouraged. 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, also called Lou Gehrig&#146;s disease) at twice the rate of veterans who did not serve in the Gulf War, the GWIRP will not accept applications focusing on ALS research. However, applications that focus on GWI symptomatology may include GW veterans with ALS if the latter disorder is included in the study&#146;s GWI case definition. [For those interested in pursuing ALS-focused studies, the office of the Congressionally Directed Medical Research Programs (CDMRP) has a separate ALS Research Program (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. Applicants 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 2014 report of the Research Advisory Committee on Gulf War Veterans&#146; Illnesses, Gulf War Illness and the Health of Gulf War Veterans: Research Update and Recommendations, 2009-2013, provides information on GWI, including case definitions and research on epidemiology, etiology, pathobiology, and treatment. The 2014 report can be found online at http://www.bu.edu/sph/files/2014/04/RAC2014.pdf. In addition, the pre-publication report (available online at http://www.iom.edu/Reports/2014/Chronic-Multisymptom-Illness-in-Gulf-War-Veterans-Case-Definitions-Reexamined.aspx) released by the Institute of Medicine includes recommendations for a consensus case definition. Funding from this award mechanism must support a clinical trial and may not 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 &#147;human subjects&#148; 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. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. If the clinical trial involves the use of a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for the proposed investigational use, evidence that an Investigational New Drug (IND) exemption application that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) has been submitted or will be submitted to the FDA within 60 days of award is required. If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) application that meets all requirements under 21 CFR 812 has been submitted or will be submitted to the FDA within 60 days of award, or that the device is exempt from an IDE, is required. The Government reserves the right to withdraw funding if the IND or IDE application has not been submitted to the FDA within 60 days of the Department of Defense (DoD) award date or 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 ITEA: &#149; The proposed clinical trial is expected to begin no later than 12 months after the award date or 18 months for FDA-regulated studies. &#149; The proposed intervention to be tested should offer significant potential impact for veterans with GWI. &#149; The proposed research project must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature and the application must identify the pathobiological mechanism being targeted. &#149; The application should describe the planned indication for the product label, if appropriate, and include an outline of the development plan required to support that indication. &#149; 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 (VA). &#149; The application should demonstrate documented availability of and access to the drug/ compound, device, and/or other materials needed, as appropriate. The quality of the product should be commensurate with FDA manufacturing standards applicable to the type and phase of product being developed (i.e., Quality System Regulation, Good Manufacturing Practices). &#149; The proposed clinical trial design should include clearly defined and appropriate endpoints, and follow Good Clinical Practice (GCP) guidelines. &#149; The application should include a clearly articulated statistical analysis plan, appropriate statistical expertise, and a power analysis reflecting sample size projections that will clearly answer the objectives of the study. &#149; The application should include a clearly articulated data management plan, and use of an appropriate database to safeguard and maintain the integrity of the data. &#149; The application should include a clearly articulated safety management plan. &#149; The application should include a clearly articulated clinical monitoring plan, outlining how the study will be monitored for GCP compliance, if applicable. &#149; The application should include a study coordinator(s) who will guide the clinical protocol through the local Institutional Review Board (IRB) of record and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. &#149; The application should include a Transition Plan (including potential funding and resources) showing how the product will progress to the next clinical trial phase and/or delivery to the market after the successful completion of the GWIRP ITEA. &#149; The application should clearly demonstrate strong institutional support. &#149; The application should acknowledge the commitment to filing the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov.
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