OpportunityTitle: DoD Gulf War Illness Treatment Evaluation Award
Description: The Treatment Evaluation Award is being offered for the first time in FY16; however, this mechanism is derived from the previously offered FY08-FY15 GWIRP Innovative Therapeutic Evaluation Award (ITEA). Impact: The Treatment Evaluation Award supports evaluation of a treatment or intervention in early phase or pilot clinical trials (Phase 0, I, or I/II) 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. The results of preliminary studies funded by this award should have the potential to provide clinical proof-of-principle data and support future development of broader efficacy studies of the proposed interventions. Scope of Research Rationale: Interventions proposed under this award mechanism may be at different stages of research development. The applicant should select one of two tracks, described below, depending on the level and type of GWI-relevant evidence available to support the proposed intervention. It is the responsibility of the Principal Investigator (PI) to select the track that is most appropriate for the intervention proposed. The two tracks are described below: &#61623; Data-Based Treatment Track: This track is intended for therapeutic approaches supported by significant preliminary data in GWI models or based on biological alterations identified in Veterans with GWI. The Data-Based Treatment Track may also include trials intended to replicate or expand prior pilot trials in GWI. Preliminary data to support the proposed treatment for GWI is required. Treatment approaches may include pharmacologic or other physiological interventions, including conventional, alternative, or complementary (combination of alternative and conventional) approaches. &#61623; Symptom-Based Treatment Track: This track is intended for innovative approaches to treat GWI that may have been utilized for other illnesses, but have not yet been studied in Veterans with GWI. For example, a pharmacological treatment or nutritional supplement suggested by previous research to be beneficial for fibromyalgia or chronic fatigue syndrome that could be evaluated in Veterans with GWI. Given the emphasis on innovation, applications are not required to include preliminary data. However, the applicant must present a sound scientific rationale established through logical reasoning and critical review and analysis of the literature explaining how the proposed therapeutic approach would be expected to be effective in treating GWI. The rationale should preferably be supported by peer-reviewed medical literature; however, other objective sources and alternative reasoning approaches will be considered. The following are important aspects for submission to the Treatment Evaluation Award: &#61623; The proposed clinical trial is expected to begin no later than 6 months after the award date. The 6 months includes the time required for all regulatory review and approval processes. &#61623; The application should include a clearly articulated statistical analysis plan appropriate to the phase of the clinical trial, a power analysis reflecting sample size projections that will clearly answer the objectives of the study, and appropriate statistical expertise. &#61623; The application must demonstrate documented availability and accessibility of the drug/compound, device, and/or other materials needed, e.g., a letter from the manufacturer assuring an adequate supply of the agent (and placebo, if necessary). The quality of the product should be commensurate with U.S. Food and Drug Administration (FDA) manufacturing standards applicable to the type and phase of product being developed (i.e., Quality System Regulation, Good Manufacturing Practices [GMP]). &#61623; Demonstration that the applicant has experience interacting with the FDA to include previous FDA submissions, etc. is encouraged. &#61623; PIs must demonstrate availability of and access to a suitable Gulf War Veteran population that will support a meaningful outcome for the study. PIs are encouraged to collaborate with an investigator who has demonstrated access to a population of Gulf War Veterans, particularly investigators within the U.S. Department of Veterans Affairs (VA). PIs should consider collaboration with one of the VA War Related Illness and Injury Study Centers http://www.warrelatedillness.va.gov/ WARRELATEDILLNESS/index.asp. &#61623; The application must include, as appropriate, 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 clinical trial, and coordinate participant accrual. &#61623; The application should include a transition plan (including potential funding and resources) showing how the anticipated product will progress to the next clinical trial phase and/or delivery to Veterans suffering from GWI after the successful completion of the FY16 GWIRP Treatment Evaluation Award. &#61623; The application should clearly demonstrate strong institutional support and commitment. &#61623; The proposed clinical trial design should include clearly defined and appropriate endpoints, and follow Good Clinical Practice (GCP) guidelines. &#61623; The application should include a clearly articulated clinical monitoring plan, outlining how the study will be monitored for GCP compliance. &#61623; The application should include a clearly articulated data management plan and use of an appropriate database to safeguard and maintain the integrity of the data. &#61623; The application should include a clearly articulated safety management plan, outlining how safety pharmacovigilance will be conducted as applicable. &#61623; The application should acknowledge commitment to filing the study in the National Institutes of Health (NIH) clinical trials registry, http://www.clinicaltrials.gov. Applications Involving Industry: Applications involving the biotechnology/pharmaceutical industry are encouraged. Biotechnology or pharmaceutical companies that apply for the Treatment Evaluation 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. Applications proposing studies whose principal focus is on the treatment of psychiatric conditions, including post-traumatic stress disorder, will be administratively withdrawn and will not be funded under this Program Announcement/Funding Opportunity.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: CDMRP Help Desk &lt;br/&gt;301-682-5507