DOD, Spinal Cord Injury, Clinical Translation Research Award
The SCIRP CTRA is intended to support high-impact and/or new/emerging clinical research that may not be ready for a larger-scale clinical trial and for which feasibility/pilot studies are necessary. Projects should demonstrate potential to impact the standard of care, both immediate and long term, or contribute to evidence-based guidelines for the evaluation and care of military Service Members, Veterans, and other individuals living with SCI.• One goal of the FY23 SCIRP CTRA is to translate current and emerging techniques and interventions into the clinical space to de-risk and inform the design of more advanced trials.• Another goal is to identify the most effective diagnosis, treatment, and rehabilitation options available to support critical decision-making for patients, clinicians, care partners, and policymakers.The application should clearly articulate the scientific and strategic steps and/or preparations the research team will take during AND after the project’s period of performance to advance the research to the next stage of clinical development/implementation.The proposed studies may be interventional or observational and may involve some retrospective data analysis. Note that purely retrospective or database-related research will not be supported under this funding opportunity, some element of prospective human enrollment should be included in the project. Small/pilot clinical trials with human subjects are allowable. Alternative trial designs to traditional randomized clinical trials are allowed but should be appropriate to the objective of the trial. If a 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.The FY23 SCIRP CTRA differs from the FY23 SCIRP Clinical Trial Award (Funding Opportunity Number HT9425-23-SCIRP-CTA) in that the CTRA allows for the execution of both clinical research projects and clinical trials, whereas the Clinical Trial Award is restricted to the execution of clinical trials only.The FY23 CTRA differs from the FY23 SCIRP Translational Research Award (Funding Opportunity Number HT9425-23-SCIRP-TRA) in that the study proposed within an application to the FY23 SCIRP CTRA may consist entirely of a clinical trial. In contrast, if a clinical trial is proposed within a Translational Research Award application, it must make up only a portion of the project’s Statement of Work.Applications to the FY23 SCIRP CTRA mechanism must support prospective clinical research or clinical trials and may not be used for animal research. Investigators seeking support to conduct studies involving animal research should consider applying to the FY23 SCIRP Translational Research Award mechanism (Funding Opportunity Number HT9425-23-SCIRP-TRA) or FY23 SCIRP Investigator-Initiated Research Award mechanism (Funding Opportunity Number HT9425-23-SCIRP-IIRA).