The SCIRP CTA supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of SCI. Applications should articulate both the short- and long-term impact of the proposed research on individuals with SCI and/or their care partners. The proposed intervention(s) to be tested should offer significant potential impact for individuals affected by SCI within the context of one or more of the FY23 SCIRP Focus Areas.
Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, phase 0), to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant populations. Alternative trial designs to traditional randomized clinical trials are allowed but should be appropriate to the objective of the trial. Utilization of decentralized clinical trial strategies that leverage virtual elements/tools for participant enrollment, communication, and data collection is especially encouraged.
The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. To help elucidate the realities of treating and managing SCIs while deployed, a resource document is now available on the CDMRP website that outlines Spinal Cord Injury Management Within the Military Health System (MHS). Applicants are encouraged to read and consider this document before preparing their applications. The resource can be accessed at https://cdmrp.health.mil/scirp/pdfs/ Beginner's%20Guide%20to%20Military%20Health%20System.pdf.
Deadlines:
Applications to the FY23 SCIRP Clinical Trial Award (CTA) 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 FY23 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. ○ 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 ○ 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 in 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 lifespan from acute to chronic injury are encouraged.
• Investigating psychosocial issues relevant to people with SCI, their families, and/or their care partners ○ Applications should directly address, or show clear relevance to, the needs of Service Members and Veterans. ○ 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 wellbeing leading to implementation of potential treatments and interventions. ○ Studies addressing social isolation, loneliness, and depression, as well as resilience, selfefficacy, sexuality and intimacy, and interactions between people living with SCI and their care partners, are especially encouraged.
• 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.
Independent investigators at all academic levels (or equivalent) may be named by the organization as the PI on the application.
Early-Career Partnering Principal Investigator: The Partnering PI must be an investigator with at least 3 years of 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 anticipated direct costs budgeted for the entire period of performance for an FY23 SCIRP CTA should not exceed $3,000,000 or $3,100,000 for the Early-Career Partnering PI Option. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.
