The TOP-NT Consortium was developed to address the bi-directional translational gap between preclinical and clinical research in TBI with a mission to develop and validate pathophysiologically based preclinical outcome measures or functional markers that align closely with practical clinical assessments in TBI and to enable the harmonization and sharing of preclinical research data. Recently, federal funding agencies have encouraged and supported efforts to harmonize data collection in preclinical neurotrauma research. For example, a set of preclinical CDE are currently available that were developed to improve transparency in preclinical reporting of animal characteristics, injury mechanism, and behavioral outcomes for preclinical TBI research. However, data collection and reporting harmonization is only a first step toward improved translation between preclinical and clinical TBI. While existing animal models mimic the injury causes, difficulties in translating promising therapeutics are exacerbated by the lack of alignment of discrete measures of the underlying injury pathology between the animal models and human subjects. Translational activities in this area largely rely on gross behavioral tests and outcomes of efficacy that correlate with injury severity in the animal models, but do not mimic practical and objective clinical measures of the underlying pathology that could facilitate patient selection or stratification for clinical trial design. Ultimately, the multi-site TOP-NT Consortium will develop, validate, and distribute new functional markers of TBI pathophysiology and provide an infrastructure model that establishes an open science approach for preclinical data collection, curation and sharing strategies that will enable broad access to methodologies and datasets developed.
At the conclusion of this session, attendees will be able to: