DoD Gulf War Illness Innovative Treatment Evaluation Award
The FY13 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/Funding Opportunity is intended to support the initial evaluation of a treatment or intervention in smaller, early phase or pilot clinical trials (Phase II or I/II, devices in U.S. Food and Drug Administration [FDA] Class I-III) and does not require preliminary data. In contrast, the FY13 GWIRP Clinical Trial Award supports the evaluation of interventions in larger, more definitive clinical trials (Phase II or III), where preliminary and preclinical evidence indicates the potential for substantial benefit for veterans with GWI. (For more information about the CTA, see http://cdmrp.army.mil/funding/gwirp.htm). The ITEA mechanism was first offered in FY09. Since then, 20 ITEA applications have been received, and 5 have been recommended for funding. The ITEA supports the early systematic evaluation of innovative treatment interventions with the potential to impact the health and lives of veterans with GWI. The results of preliminary studies funded by this award can provide 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 ill Gulf War 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 of the research must be clearly on GWI and not on another disease process. This award mechanism is designed to evaluate a broad scope of treatment approaches with potential for widespread 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. 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: • Global health measures (biomarkers) and/or functional status • 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 • 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’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’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 2008 report of the Research Advisory Committee on Gulf War Veterans’ 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 is available online at http://www1.va.gov/RAC-GWVI. 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. In this case, investigators are encouraged to apply to the GWIRP Clinical Trial Award, which supports Phase II or Phase III clinical trials (http://cdmrp.army.mil/funding/gwirp.shtml). 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 “human subjects” 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://cdmrp.org/Program_Announcements_and_Forms/. If the proposed study involves the use of a drug that has not been approved by the FDA for its investigational use, evidence that an Investigational New Drug (IND) application has been submitted or will be submitted within 60 days of award is required. If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) has been submitted or will be submitted 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 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: • The proposed clinical trial is expected to begin no later than 12 months after the award date. • The proposed intervention to be tested should offer significant potential impact for ill Gulf War veterans. • 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. • The application must demonstrate availability of, and access to, a suitable Gulf War veteran population that will support a meaningful outcome for the study. The PI should 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. • The application should demonstrate documented availability of and access to the drug/ compound, device, and/or other materials needed, as appropriate. • The proposed clinical trial should include clearly defined and appropriate endpoints. • 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. • 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, as appropriate to the study design. • The application should include a Transition Plan showing how the product will progress to the next clinical trial phase after successful completion of the award, including potential resources and funding mechanisms. • The application should clearly demonstrate strong institutional support.
Office: U.S. Army Medical Research Acquisition Activity
301-682-5507
