DoD Gulf War Illness Clinical Trial Award

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The FY15 GWIRP is offering two award mechanisms to evaluate potential interventions for GWI: the Clinical Trial Award 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, U.S. Food and Drug Administration [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 0, I, or I/II), and does not require preliminary data. For information about the ITEA, see http://cdmrp.army.mil/funding/gwirp.shtml. The Clinical Trial Award mechanism was first offered in FY08. Since then, 14 Clinical Trial Award applications were received, and 4 were recommended for funding. The Clinical Trial Award 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 improvements in overall functional status or in symptom complexes (e.g., cognitive function, musculoskeletal/pain symptoms, gastrointestinal symptoms, fatigue, respiratory problems, skin abnormalities, sleep difficulties and others) individually and/or as they may interact with each other. Proposed studies may be single-center or multi-center clinical trials. Applications may be submitted by a single Principal Investigator (PI) or by a team of investigators led by an Initiating PI with up to three Partnering PIs. Multiple PI Option: The FY15 GWIRP supports collaborative projects to bring a new perspective to GWI research and/or facilitate advancement of GWI treatments through synergistic partnerships. Therefore, the FY15 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 “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 treatment modalities or comparing untested or novel treatments for GWI symptoms. It should be clear that all investigators have an appropriate level of intellectual input and effort. The Initiating PI should have demonstrated expertise in GWI research, while the Partnering PIs may contribute expertise from a different field that can be applied to GWI. Multidisciplinary and multi-organizational projects are encouraged. If the project is multi-organizational, applications 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/Funding Opportunity. 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, also called 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) offers a separate ALS research program (see http://cdmrp.army.mil/alsrp)]. Applications Involving Industry: Applications involving the biotechnology/pharmaceutical industry are encouraged whether as Single or Initiating PIs, Partnering PIs or simply named collaborators. Biotechnology or pharmaceutical companies who apply for the Clinical Trial Award, as an individual applicant or as part of a collaboration, are encouraged to leverage their own resources to complement the funding provided by this award.

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