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Congressionally Directed Medical Research Programs (CDMRP) -- Spinal Cord Injury Research Program (SCIRP) -- Clinical Trial Award
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. 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.
SCI Lived Experience Consultation: The research team must include at least 2 people with lived SCI experience who will provide advice and consultation throughout the planning and implementation of the research project. Interactions with other team members should be well integrated and ongoing. SCI Lived Experience Consultants include individuals with a SCI, their family members, or care partners. These individuals should provide an independent voice and objective input on the research and its potential impact for people living with SCI.
- Pre-Application Deadline: May 21, 2020
- Invitation to Submit an Application: June 2020
- Application Submission Deadline: August 25, 2020
Areas of Interest
To meet the intent of the award mechanism, applications must address at least one of the FY20 SCIRP CTA Focus Areas listed below. Applications may address more than one Focus Area. Applications using clinically relevant combinations of interventions within or across Focus Areas are encouraged. Although “biomarkers” is not a separate FY20 SCIRP CTA Focus Area, applications responsive to one of the Focus Areas below and including a biomarker component are also encouraged. The FY20 SCIRP CTA 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.
• Bowel, genitourinary, cardiopulmonary dysfunction, and neuropathic pain: ○ Includes studies of the mechanisms of dysfunction specific to SCI where the application demonstrates 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. ○ Studies relevant to this Focus Area using qualitative research approaches are allowed.
• 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. ○ Studies of depression, resilience, or self-efficacy are especially encouraged. ○ Studies may address the causes of psychosocial issues, diagnosis, 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 are supported. ○ Studies relevant to this Focus Area using qualitative research approaches are allowed.
Independent investigators at all academic levels (or equivalent) may be named by the organization as the Principal Investigator (PI) on the application. 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 FY20 SCIRP Clinical Trial award will not exceed $3,000,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.