The Future of Clinical Trials in Traumatic Brain Injury
Over the past 30 years, clinical trials have repeatedly failed to demonstrate a definitive benefit of any neuroprotective agent for moderate or severe traumatic brain injury (TBI). As a result, TBI researchers have called for a critical reappraisal of the design, conduct, and analysis of TBI clinical trials. Some have argued that key limitations in preclinical research continue to hinder the translation of bench science to the clinical world. Others have focused on the details of the clinical trials themselves, arguing that the heterogeneous nature of TBI calls for unique considerations with regard to trial design, sample size, subject recruitment, outcome measurement, and statistical analysis in future clinical trials.
KeywordsClinical trial Ordinal analysis Sample size Prognostic model Traumatic brain injury
Acknowledgments and Disclosures
This work was supported in part by the Department of Defense PTSD/TBI Clinical Consortium (HME). Dr. Eisenberg is an unpaid consultant for InSightec Ltd. and is an independent neurotrauma consultant to the National Football League.
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