DoD Gulf War Illness Clinical Trial Award
The FY13 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, nine Clinical Trial Award applications have been received, and three 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: • 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 New for FY13: The CTA can be used for comparative research of GWI treatments and multi-center trials comparing treatments. Such studies can be executed by a team of investigators led by an Initiating Principal Investigator (PI) with up to three Partnering PIs. Multiple PI Option: The FY13 GWIRP supports collaborative projects to bring a new perspective to GWI research and/or facilitate advancement of GWI treatments through synergistic collaborations. Therefore, the FY13 GWIRP is offering a Multiple PI Option for this award mechanism. The Multiple PI Option is structured so that up to four investigators, each of whom will be designated as a PI and receive a separate award, will work synergistically on a single project. One member of the team will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with the application. The other member(s) will be referred to as the Partnering PI(s) (maximum of three). All the investigators must collaborate to submit a single project examining one or more innovative treatment modalities or comparing untested or novel treatments for GWI symptoms. It should be clear that all investigators have an equal level of intellectual input and effort. Partnering PIs may bring expertise from a field that is applicable to GWI, though the Initiating PI should have demonstrated expertise in GWI research. Multidisciplinary and multi-organizational projects are encouraged. If the project is multi-organizational, PIs should include plans for communication between investigators at each organization. Additionally, participating organizations must be willing to resolve potential intellectual and material property issues and to remove any barriers that might interfere with achieving high levels of cooperation to ensure successful completion of the project. Application responsibilities unique to Partnering PIs will be identified in the supporting sections of this Program Announcement. Applications proposing studies whose principal focus is on the treatment of psychiatric conditions, including post-traumatic stress disorder (PTSD), will be administratively withdrawn and 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. [For those interested in pursuing ALS-focused studies, the office of the Congressionally Directed Medical Research Programs (CDMRP) is offering a separate ALS research program in FY13 (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 can be found online at: http://www1.va.gov/RAC-GWVI. Applications are required to include preliminary data, which does 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 application would not be deemed in keeping with the intent of the CTA. In this case, investigators are encouraged to apply to the GWIRP Innovative Treatment Evaluation Award, which 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 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 the GWIRP Investigator- Initiated Research Award (http://cdmrp.army.mil/funding/gwirp.shtml). 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 on clinical research, see the Human Subject Resource Document at https://cdmrp.org/Program_Announcements_and_Forms/. 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, 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 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 Clinical Trial Award: • 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 application should demonstrate documented availability of and access to the drug/compound, device, or other intervention to be used in the proposed trial in sufficient quantities and ready for clinical trials, as appropriate. • 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. • 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. Preliminary data supporting the rationale must also be provided. • 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. • 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 ill Gulf War veteran population after successful completion of the GWIRP CTA. • The application should demonstrate evidence of institutional support.
Office: U.S. Army Medical Research Acquisition Activity
301-682-5507
