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Despite improvements in mortality, functional outcomes from traumatic brain injury (TBI) remain unsatisfactory. Death or disability is seen in nearly half of the patients who are admitted to an ICU, and half of patients with mild TBI show incomplete recovery at six months post-injury. Further, TBI drives progressive pathology and accelerates late neurodegeneration, but these long-term outcomes are difficult to address in conventional research studies.
Current therapies are not mechanistically based and make no attempt to personalise interventions based on disease mechanisms in individuals. Indeed, such poorly targeted therapy may be an important reason why promising preclinical results have failed to translate to effective treatments, and an expensive series of failed drug trials has resulted in pharma industry largely disengaging from TBI drug development. Larger, publicly funded, pragmatic clinical trials have provided some guidance regarding the use of common interventions (usually in the most severely injured patients). However, the data from these studies have had limited use beyond their primary aim – and represent a huge untapped reservoir of high-quality data for improving our understanding and clinical management of TBI.
The urgent need for better treatments for TBI requires re-engagement of industry based on new models for drug development. Large observational studies in the International Traumatic Brain Injury Research (InTBIR) initiative have provided new data on clinical and outcome characterisation, blood biomarkers, and advanced neuroimaging, extensively reviewed in recent Lancet Neurology Commissions on TBI. 1 These advances allow better characterisation of patients, identification of patient subsets for more precise application of mechanistically driven therapies, and intermediate endpoints for early-stage trials that could de-risk drug development pathways.
Further, efficient and effective approaches to improving discoverability and use of datasets from past studies could increase the value of these datasets and deliver new insights regarding TBI mechanisms and management. Finally, linkage of data from large research initiatives and routine clinical care could reduce research costs and record long term outcomes over years and decades.
Our multi-disciplinary, multi-centre consortium of globally leading UK investigators in TBI-REPORTER aims to address these challenges and opportunities across the TBI severity spectrum in a range of patient cohorts. We will integrate these efforts with similar international initiatives in InTBIR.
This Investigator Brochure, which will be regularly updated, aims to provide potential academic and industrial collaborators with information regarding TBI-REPORTER, catalogue research resources available for collaborators, and detail the process through which new partners can seek interactions with TBI-REPORTER.
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