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/optimization 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 FY24 SCIRP CTRA is to translate current and emerging techniques and interventions into the clinical space by de-risking and informing the design of more advanced trials. Research supported by the FY24 SCIRP CTRA may help prepare future clinical trials to overcome barriers to success. Relevant research may address, but is not limited to:
○ Determination/identification of the most appropriate study population for future efficacy trials
○ Evaluation/optimization of study/intervention parameters
○ Refinement of trial design for acceptance and scalability
• 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.
Deadlines:
- Pre-Application Deadline: May 20, 2024
- Invitation to Submit an Application: July 2024
- Application Submission Deadline: Aug. 30, 2024
To meet the intent of the funding opportunity, applications to the FY24 SCIRP Clinical Translation Research Award (CTRA) must address at least one of the Focus Areas listed below. Applications may address more than one Focus Area. In particular, applications combining biomarker studies with studies in one or more of the other Focus Areas are encouraged. Applications using clinically relevant combinations of interventions within or across Focus Areas are also encouraged. The FY24 SCIRP 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, especially within the battlefield/deployed environment.
○ 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 evaluation of treatment efficacies
○ To be responsive to this Focus Area, biomarker identification or validation must be the primary focus of the proposed research.
○ 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.
• Developing, testing, and validating promising interventions to address bowel, genitourinary, neuropathic pain, cardiopulmonary or autonomic dysfunction across the life span of people with SCI
○ Mechanism-focused studies must be specific to SCI and demonstrate a clear path from increased understanding to advancing treatments.
○ Studies addressing the needs of and treatments for individuals with SCI across the full life span from acute to chronic injury are encouraged.
• Investigating psychosocial issues relevant to people with SCI, their families, and/or their care partners across the life span
○ To be responsive to this Focus Area, psychosocial issues must be the primary focus of the research.
○ Projects should provide an understanding of critical factors promoting psychosocial well-being leading to implementation of potential treatments and interventions.
○ Studies addressing social isolation, loneliness, and depression, as well as resilience, self-efficacy, sexuality and intimacy, and interactions between people living with SCI and their care partners, are especially encouraged.
○ Applications should consider or directly address the needs of Service Members and Veterans across the life span.
• 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 to promote recovery of function.
Single PI Option
Principal Investigator: Independent investigators at all career levels may be named by the organization as the PI on the application.
Early-Career Partnership Option
If exercising the Early-Career Partnership Option, at least one of the named PIs (Initiating or Partnering) must be an investigator with at least 3 years research experience (independent or non-independent) beyond a terminal degree but no more than 7 years within their first faculty appointment, or equivalent independent research position (excluding time spent on family medical leave). Lapses in research time or appointments as denoted in the biographical sketch should be explained in the application. The other PI (Initiating or Partnering) may be an independent investigator at any career level.
The anticipated direct costs budgeted for the entire period of performance for an FY24 SCIRP CTRA should not exceed $1,250,000 or $1,350,000 for the Early-Career Partnership Option. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.