Gulf War Illness, Clinical Evaluation Award

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The FY19 GWIRP Clinical Evaluation Award supports translation of validated GWI research, including qualified and replicated preclinical findings, to a Gulf War Veteran population. The Clinical Evaluation Award targets the Verification phase of the research pipeline as outlined in Section II.A.2 . Statistically powered biomarker trials with the potential to validate use of biomarkers as clinical endpoints or proof-of-concept intervention trials (e.g., pilot, first in human, Phase I-IIa) are encouraged under this funding opportunity. While studies of treatments repurposed from other disorders sharing GWI symptomatology will be considered (with appropriate rationale), the FY19 GWIRP encourages studies that translate qualified results from the GWI research community. New FY19 clinical trial definition: A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Clinical trials may be designed to evaluate pharmacologic agents (drugs or biologics), devices, clinical guidance or other approaches, and technologies supported by strong objective evidence in the GWI field. Clinical trials may also examine repurposing of existing U.S. Food and Drug Administration (FDA)-approved drugs. Biomarker investigations must expand preliminary findings in a GWI cohort large enough to produce a statistically meaningful outcome. Biomarker study outcomes shall provide validation of use as clinical endpoints in large-scale (Phase IIb-III) clinical trials. Funding from this award mechanism must support research in a Gulf War Veteran population. Proof of availability and access to necessary cohort(s) and/or critical reagents must be provided. Applications must state a realistic timeline for clinical investigation. The requested budget must be commensurate with the phase and size of the trial proposed. Refer to Section II.D.5, Funding Restrictions for detailed funding information.

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