Translational obstacles with off-label drug use in acute traumatic brain injury

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Traumatic brain injury results in significant morbidity and mortality, and there is an urgent need for neuroprotective medications that can prevent the persisting symptoms and disabilities following injury. Several existing pharmacotherapies have been targeted for off-label benefit in traumatic brain injury, as these agents are well characterized and commercially available, easing the process of clinical trial development. Despite promising results in animal models, clinical trials have demonstrated minimal benefit. One possible reason for these failed translations could be that drug selection, characterization and dosing are not routinely established in the appropriate early phase trials before larger scale testing. Examining how recent trials may have bypassed these steps may help future trials to more definitively determine the efficacy of potential therapeutics.

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