DOD, Spinal Cord Injury, Clinical Trial Award

Description

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.Employing community collaborations to optimize research impact is required. Research funded by the FY23 SCIRP CTA should be responsive to the needs of people with SCI, their families, and/or their care partners. Research teams are therefore required to establish and utilize effective and equitable collaborations and partnerships with community members to maximize the translational and impact potential of the proposed research. Applications to the FY23 SCIRP CTA are expected to name at least two community partners (e.g., SCI Lived Experience Consultants, representatives of community-based organizations) who will provide advice and consultation throughout the planning and implementation of the research project (see Attachment 4, Collaborative Research Plan).Collaborative research approaches, such as community-based participatory research, participatory action research, and integrated knowledge transition, create partnerships between scientific researchers and community members to create knowledge useable by both sets of stakeholders. Recognizing the strengths of each partner, scientific researchers and community members collaborate and contribute equitably on all aspects of the project, which may include needs assessment, planning, research intervention design, implementation, evaluation, and dissemination. Collaborative research approaches feature shared responsibility and ownership for the research project to ensure non-tokenistic involvement of community members within the research team. Research results are jointly interpreted, disseminated, fed back to affected communities, and may be translated into interventions or policy. These methods are critically important for community-level interventions and can also have important impacts on translational research and prototype development to identify and augment the potential impact of a research program on people living with SCI, their families, and/or their care partners.Collaborative relationships with the lived experience community are often established through integrating community members into research teams as co-researchers, advisors, and/or consultants. Some examples for implementing collaborative research approaches include:• Lived Experience Consultation: The research team includes at least one project advisor with lived SCI experience who will provide advice and consultation throughout the planning and implementation of the research project. Lived Experience Consultants may include individuals with SCI, their family members, and/or their care partners.• Partnership with a Community-Based Organization: The research team establishes partnerships with at least one community-based organization that provides advice and consultation throughout the planning and implementation of the research project. Community-based organizations may include advocacy groups, service providers, policymakers, or other formal organizational stakeholders.• Community Advisory Board Utilization: A community advisory board is composed of multiple community stakeholders and can take many forms, from a board of Lived Experience Consultants to a coalition of community-based organizations or any combination thereof. As with Lived Experience Consultants and organizational partners, the community advisory board provides advice and consultation throughout planning and implementation of the research project.

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