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Congressionally Directed Medical Research Programs (CDMRP) -- Gulf War Illness Research Program -- Clinical Partnership Award
The GWIRP Clinical Partnership Award mechanism is being offered for the first time in FY16.
The Clinical Partnership Award supports research into the diagnosis and treatment of GWI that will accelerate the movement of promising ideas in GWI research into clinical applications to benefit Veterans with GWI in a manner that would be less readily achievable through independent efforts. The intent of this award is to inform and advance clinical practice, not just from testing/evaluating treatments in a translational model, but also by individualizing treatment plans, experimenting with potential treatments, or informing biomarker or pathophysiology research from a clinical case series and/or other research-informing clinical modalities. The award is designed to encourage multi-institutional, multidisciplinary research partnerships among two or three investigators, referred to as the Initiating Principal Investigator (PI) and the Partnering PI(s), each of whom will receive a separate award. There must be at least one laboratory scientist and at least one clinician participating in the partnership. A clinician is defined as an individual who is credentialed (possesses the necessary degrees, licenses, and other certifications) as a care provider in any relevant capacity at the institution of record. Applicants must have in place, or have well-justified prospects of, a suitable and sufficient GWI patient clinical care population. In addition, at least one partner must have significant experience in GWI research. Biographical sketches should include appropriate documentation of credentials.
Observations that drive a research hypothesis may be derived from a laboratory discovery, population-based studies, or a clinician’s firsthand knowledge from providing care to patients. While the ultimate goal of translational research is to move an observation forward into clinical application, members of the partnership should view translational research as a two-way continuum between bench and bedside. The research plan should involve a reciprocal flow of ideas and information within the partnership. The Initiating and Partnering PI(s) have different submission requirements; however, all partners must provide substantial intellectual input into the design of the research project and both PIs should contribute significantly to the development of the Project Narrative, Statement of Work (SOW), and other required components. A proposed project in which a clinical partner merely supplies tissue samples or access to patients does not meet the intent of this mechanism. Developmental pathways for translational research that may be useful for designing translational research studies for support under this mechanism may be found within the following resource: Hawk ET, Matrisian LM, Nelson WG, et al. 2008. The Translational Research Working Group Developmental Pathways: Introduction and Overview, Clin Cancer Res 14:5664-71. These pathways, while created for cancer research initiatives, have broad applicability to other areas of research, are comprehensive, and span the entire translational research continuum from discovery of a target to clinical trials.
The Clinical Partnership Award is not intended to support clinical trials, but may support correlative studies that are associated with an existing clinical trial or projects that optimize the design of future clinical trials. Limited exploratory clinical testing to establish feasibility of a potential approach or to aid in device or intervention refinement may be supported. Investigators seeking support for a clinical trial should utilize the FY16 GWIRP Treatment Evaluation Award mechanism; see http://cdmrp.army.mil/funding/gwirp.shtml. A clinical trial is defined as a prospective accrual of patients for a study 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 safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. For more information on distinguishing clinical trials from clinical research, a Human Subject Resource Document is provided at https://cdmrp.org/Program_Announcements_and_Forms/.
• Pre-Application Deadline: July 15, 2016
• Invitation to Submit an Application: August 2016
• Application Submission Deadline: October 20, 2016
Independent investigators at all academic levels (or equivalent) are eligible to submit applications. ○ There must be at least one laboratory scientist and at least one clinician participating in the partnership (minimum of 2 and maximum of 3 partners). ○ At least one partner must have significant experience in GWI research or Gulf War Veteran clinical care.
- The maximum period of performance is 3 years.
- The anticipated direct costs budgeted for the entire period of performance will not exceed $750,000. Indirect costs are to be budgeted in accordance with the organization’s negotiated rate. No budget will be approved by the Government exceeding $750,000 direct costs or using an indirect rate exceeding the organization’s negotiated rate.