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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. 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 the one or more of the FY21 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.
SCI Lived Experience Consultants: 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. The proposed research project is expected to integrate input from the SCI Lived Experience Consultants. 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.
Early-Career Partnering PI Option: The FY21 SCIRP encourages applications that include meaningful and productive collaborations between investigators. The FY21 CTA includes an option for an Early-Career Partnering PI. The PIs may have experience in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. The Partnering PI Option is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The Early-Career PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, SOW, and other required components. If recommended for funding, each PI will be named to an individual award within the recipient organization.
- Pre-Application Deadline: May 24, 2021
- Invitation to Submit an Application: July 2021
- Application Submission Deadline: Sep. 3, 2021
Areas of Interest
Applications to the FY21 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 is encouraged. Applications using clinically relevant combinations of interventions within or across Focus Areas are also encouraged. The FY21 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 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.
• Bowel, genitourinary, cardiopulmonary dysfunction, and neuropathic pain ○ 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.
• Psychosocial issues relevant to people with SCI, their families, and/or their carepartners ○ Applications should directly address, or show clear relevance to, the needs of Service Members and Veterans. ○ 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, selfefficacy, and interactions between people living with SCI and their care-partners are especially encouraged. ○ Preclinical animal studies are not responsive to this Focus Area.
• 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.
Independent investigators at all academic levels (or equivalent) may be named by the organization as the PI on the application.
The partnering PI must be an independent, early-career investigator within 10 years after completion of their terminal degree by the time of the application submission deadline (excluding time spent in residency or on family medical leave). Time spent as a postdoctoral fellow is not excluded. 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 FY21 SCIRP Clinical Trial Award will not exceed $3,000,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.