Traumatic brain injury (TBI) is the greatest cause of death and severe disability in young adults; its incidence is increasing in the elderly and in the developing world. Outcome from severe TBI has improved dramatically as a result of advancements in trauma systems and supportive critical care, however we remain without a therapeutic which acts directly to attenuate brain injury. Recognition of secondary injury and its molecular mediators has raised hopes for such targeted treatments. Unfortunately, over 30 late-phase clinical trials investigating promising agents have failed to translate a therapeutic for clinical use. Numerous explanations for this failure have been postulated and are reviewed here. With this historical context we review ongoing research and anticipated future trends which are armed with lessons from past trials, new scientific advances, as well as improved research infrastructure and funding. There is great hope that these new efforts will finally lead to an effective therapeutic for TBI as well as better clinical management strategies.
Key points
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Traumatic brain injury (TBI) is the greatest cause of death and severe disability in young adults; its incidence is increasing in the elderly and in the developing world.
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Mortality rates have decreased from more than 80% for severe TBI in the 1940s to about 20% currently in well-resourced hospitals, largely as a result of improvements in trauma systems and supportive critical care.
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Recognition of secondary injury and secondary insults has led to novel basic science and clinical approaches aimed at improving outcomes from TBI.
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Over 30 late-phase clinical trials have failed to translate a therapeutic agent for clinical use and numerous explanations for this failure have been postulated.
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New research is armed with lessons from past trials, new scientific advances, as well as improved research infrastructure and funding; there is great hope that an effective therapeutic for TBI will be translated to clinical use in the coming years.

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