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Congressionally Directed Medical Research Programs (CDMRP) -- Spinal Cord Injury Research Program (SCIRP) -- Translational Research Award
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 healthcare 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, PIs 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. Developmental pathways for translational research that may be useful for designing translational research studies for support under this mechanism may be found at http://clincancerres.aacrjournals.org/content/14/18/5664.full (a report of the National Cancer Institute Translational Research Working Group); applicants are strongly encouraged to refer to these pathways in their applications.
- Pre-Application Deadline: May 29, 2019
- Invitation to Submit an Application: June 2019
- Application Submission Deadline: August 27, 2019
Areas of Interest
To meet the intent of the award mechanism, applications must address at least one of the FY19 SCIRP TRA Focus Areas. Applications may address more than one Focus Area. In particular, applications combining biomarker studies with studies of one or more of the following Focus Areas are encouraged: preserving and protecting tissues after injury; bladder dysfunction, bowel dysfunction, and neuropathic pain; and rehabilitation and regeneration. Applications using clinically relevant combinations of interventions within or across Focus Areas are also encouraged. The FY19 SCIRP TRA Focus Areas are:
• Preserving and protecting spinal cord tissue at time of injury for improved neurologic outcomes: ○ Responsive projects may include surgical and acute care management of SCI. ○ Early therapeutics (devices and pharmacologic interventions) to stabilize SCI in the prehospital environment and during transport are encouraged. ○ Applications proposing neuroprotective interventions need to demonstrate a clinically feasible window for treatment and more than an incremental improvement over existing therapies.
• Identifying and validating biomarkers for diagnosis, prognosis, and for evaluation of treatment efficacies: ○ Biomarkers must focus on diagnosis, prognosis, progression, and/or recovery of SCI. ○ Projects with a clear link between a biomarker and underlying physiology are encouraged. Projects can include imaging and other modalities. ○ Applications should demonstrate a clear path to clinical use. ○ Biomarker studies directed at identifying the best single or combination of treatments for individuals (personalized medicine) are encouraged. ○ Clinical trials are not supported in the FY19 SCIRP TRA biomarkers Focus Area; however, ancillary biomarker studies with existing clinical trials are allowed and encouraged.
• Bladder dysfunction, bowel dysfunction, and neuropathic pain: ○ Includes studies of the mechanisms of bladder and bowel dysfunction and pain in individuals with SCI where the application demonstrates a clear path from increased understanding to advancing treatments. ○ Includes developing and testing interventions such as drugs, devices, and rehabilitation strategies. ○ Studies addressing the needs of and treatments for individuals with SCI across the full lifespan from acute to chronic injury are encouraged. ○ Studies relevant to this Focus Area using qualitative research approaches are allowed.
• Psychosocial issues relevant to SCI in individuals with SCI and their caregivers: ○ Applications directly addressing the needs of Service members and Veterans are strongly encouraged. Applications including other populations must show clear relevance to Service members and/or Veterans. ○ Applications addressing the needs of caregivers are encouraged. ○ Studies of depression, resilience, and self-management are especially encouraged. ○ Studies may address the causes of psychosocial issues and/or interventions designed to promote adjustment, independent living, and social participation, and to improve quality of life. ○ Preclinical animal studies are not responsive to this Focus Area. ○ Studies relevant to this Focus Area using qualitative research approaches are allowed.
• Rehabilitation and regeneration—maximizing the function of the residual neural circuitry, including harnessing neuroplasticity and recovery to improve function after SCI. ○ Studies that address critical questions of dosing, targeting, or safety required to move the research toward clinical use are supported. ○ Applications studying mechanisms of regeneration or identifying novel therapeutic targets must include a feasible projected pathway for translation and clinical implementation. ○ Basic research projects designed to understand general mechanisms underlying axonal sprouting, regeneration, or neuroplasticity are discouraged unless they directly address translatable approaches. ○ Studies relevant to this Focus Area using qualitative research approaches are allowed.
Independent investigators at all academic levels (or equivalent) are eligible to submit applications. An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by, or affiliated with, an eligible organization.
The anticipated direct costs budgeted for the entire period of performance for an FY19 SCIRP TRA will not exceed $1,250,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information