DOD, Spinal Cord Injury, Translational Research Award

Description

The SCIRP TRA is intended to support translational research that will accelerate the movement of promising ideas in SCI research into clinical applications. Although not all-inclusive, some examples include demonstration studies of pharmaceuticals and medical devices in preclinical systems and/or clinical research on therapeutics, devices, or practice using human tissues or resources.The ultimate goal of translational research is to move an observation forward into clinical application and accelerate the clinical introduction of health care products, technologies, or practice guidelines. Observations that drive a research idea may be derived from a laboratory discovery, population-based studies, or a clinician’s first-hand knowledge of patients and anecdotal data. However, applicants should not view translational research as a one-way continuum from bench to bedside. The research plan is encouraged to involve a reciprocal flow of ideas and information between basic and clinical science.Applicants need to clearly articulate three points along the translational research spectrum:• Where the field is now;• Where the field will be after the successful completion of the proposed research project; and• What the next step will be after completion of the proposed project.Applications must include preliminary and/or published data that are relevant to SCI and supports the proposed research project.Applications to the FY23 SCIRP TRA may include preclinical animal studies (except where otherwise specified) and/or clinical research involving human subjects and human anatomical substances. Proposal of animal studies is not a required element of this mechanism though applications including animal studies must include a clear justification for the animal model chosen including relevance to human SCI. The FY23 SCIRP TRA may also support ancillary studies that are associated with an ongoing or completed clinical trial and projects that optimize the design of future clinical trials.The FY23 SCIRP TRA also allows funding for a pilot clinical trial as PART of the funded research project where limited clinical testing of a novel intervention or device is necessary to inform the next step in the continuum of translational research. Such pilot clinical trial studies should be small, make up only a portion of the proposed Statement of Work (SOW), and be utilized to establish feasibility of a potential approach or to aid in device or intervention refinement. Alternative trial designs to traditional randomized clinical trials are allowed but should be appropriate to the objective of the trial. If a pilot clinical trial is proposed, utilization of decentralized clinical trial strategies that leverage virtual elements/tools for participant enrollment, communication, and data collection is especially encouraged. Applications that include a pilot clinical trial as part of the proposed research will have additional submission requirements and review criteria. Applications that consist entirely of a clinical trial or multiple pilot clinical trials may be administratively withdrawn.

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