Enhancing Data Sharing for Preclinical Traumatic Brain Injury Research with Common Data Elements

Preclinical traumatic brain injury (TBI) research is critical for elucidating pathobiology, identifying biomarkers, and developing potential therapies that would not be possible through clinical research alone. However, successful translation of preclinical results to the clinic has been problematic due to multiple factors, including a failure to consistently replicate preclinical data between laboratories. In part, the replicability problem is due to insufficient rigor and transparency and lack of standardized, common data reporting formats. The PRE-Clinical Interagency reSearch resourcE-TBI (PRECISE-TBI) was established in 2021 to develop cross-cutting resources, including instituting a usable common data element (CDE) framework to help tackle this problem. Development of a central preclinical CDE resource will parallel clinical efforts and define a minimal list of variables that have been designated as both common and important for replication by domain experts across the neurotrauma research community. Using a common, structured data format that unifies the reporting of common methods and outcome variables will increase transparency and rigor across the field and enhance data sharing for reuse. We provide an update on these efforts from 2021 to 2026, presenting the PRECISE-TBI CDE development process for subject and study level variables, TBI injury models, common behavioral tasks, targeted biomarker assays, and magnetic resonance imaging (MRI) and spectroscopy data acquisition. We highlight application of these CDEs using a series of case studies that exemplify how data can be mapped to CDEs both prospectively and retrospectively. These use cases inform both researchers and data scientists about real-world challenges and serve as the basis for iterative improvements as CDE use evolves.