Gulf War Illness, Clinical Trial Award

Description

The FY18 GWIRP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on GWI. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. 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). Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, Phase 0) to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in GWI Veteran populations. For applications proposing initial evaluation of a treatment or intervention in smaller, early phase or pilot clinical trials, innovation is an important component and therefore preliminary data are not required. 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 multisymptom illnesses, but has not yet been studied in Veterans with GWI. Larger, more definitive clinical trials, including expansion of previous promising pilot trials, must include preliminary data with respect to safety in a GWI Veteran population. 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. New in FY18! Biorepository Contribution Option: In FY17, the GWIRP awarded infrastructure support for a Gulf War Illness Biorepository. The “Boston Biorepository, Recruitment, and Integrative Network (BBRAIN) for GWI” has now been established for the retention and distribution of biospecimens and/or data related to GWI research. Applicants to the FY18 GWIRP are encouraged to contribute biospecimens and data to this repository network. The FY18 GWIRP Clinical Trial Award offers a nested Biorepository Contribution Option with higher levels of funding for qualified applications as described in Section II.D.5, Funding Restrictions. For the application to qualify for a higher level of funding, the Principal Investigator (PI) must submit a Biorepository Contribution Statement (see Attachment 13) providing a detailed accounting of proposed costs and a commitment to work with protocols and Standard Operating Procedures (SOPs) developed by the BBRAIN for quality assurance purposes. Applicants interested in collaborating with this network should refer to the Research Resources link (http://cdmrp.army.mil/gwirp/resources/gwirpresources) on the GWIRP website.

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