Traumatic Brain Injury (TBI) is a contributing factor in a third of all injury-related US deaths. An estimated 3.2 to 5.3 million people live with the long-term physical, cognitive, and psychological health disabilities of TBI, with annual direct and indirect costs estimated at over $76 billion. The NINDS-funded, multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study aims to change this.
QuesGen Systems is the Data Management platform for TRACK-TBI.
QuesGen was selected for several significant TBI and other neurology-related projects, for which QuesGen developed a large library of electronic Case Report Forms (eCRFs) And neurocognitive assessments.
QuesGen has worked with TRACK-TBI since 2010
3,700 participants to date
18 clinical data collection sites
QuesGen was selected for several significant TBI and other neurology-related projects, for which QuesGen developed a large library of electronic Case Report Forms (eCRFs) and neurocognitive assessments.
Clinical, imaging, proteomic, genomic and clinical outcome databases will be linked into a shared platform that will promote a model for collaboration among scientists within InTBIR and elsewhere, which was originally funded by the Grand Opportunity Grant (GO study).
- Enrolled over 3,700 participants to date, including ortho controls and friend controls
- 18 clinical data collection sites
- Infrastructure of integrated databases, imaging repositories, and biosample repositories
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TRACK-TBI is built from the foundational NINDS-funded TRACK-TBI Pilot study, which collected clinical data from 3 sites and 600 subjects.
With more than ﬁfteen publications and growing, the TRACK-TBI Pilot dataset is the ﬁrst to populate the Federal Interagency Traumatic Brain Injury Research (FITBIR) repository and with the current TRACK-TBI data, is compatible with the International Initiative for Traumatic Brain Injury (InTBIR), a collaborative eﬀort of the European Commission (EC), the Canadian Institutes of Health Research (CIHR) and the National Institutes of Health (NIH).
The global aim of this project is to test and reﬁne Common Data Elements (CDEs), neuroimaging standards, and best practices for genetics and proteomics in TBI studies.
The investigators anticipate that this project has the potential to substantially advance and revolutionize clinical research in TBI. Repositories for neuroimaging, proteomic, and genetic biomarkers will facilitate the evolving ﬁeld of these emerging technologies in TBI. TRACK-TBI also forms one of the core datasets of the Department of Defense-funded TBI Endpoints Development (TED) Initiative, which has established an interrogatable Metadataset of high-quality studies across civilian, sports, and military populations.
TED’s (TBI Endpoints Development Initiative) goals, aligned with TRACK-TBI, are to identify and validate the FDA regulatory readiness of candidate clinical outcome assessments and proteomic and neuroimaging biomarkers and technologies that may serve as endpoints in the design of precision clinical trials.
To date, there are 76 TRACK-TBI publications, with additional articles expected in the future.