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Current status of neuroprotection trials for traumatic brain injury: lessons from animal models and clinical studies
M R Bullock1, B G Lyeth, J P Muizelaar
1Division of Neurosurgery, Medical College of Virginia, Virginia Commonwealth University, Richmond, USA.
Abstract:
Laboratory studies have identified numerous potential therapeutic interventions that might have clinical application for the treatment of human traumatic brain injury. Many of these therapies have progressed into human clinical trials in severe traumatic brain injury. Numerous trials have been completed, and many others have been prematurely terminated or are currently in various phases of testing. The results of the completed Phase III trials have been generally disappointing, compared with the expectations produced by the successes of these interventions in animal laboratory studies. In this review, we summarize the current status of human traumatic brain injury clinical trials, as well as the animal laboratory studies that led to some of these trials. We summarize criteria for conducting clinical trials in severe traumatic brain injury, with suggestions for future improvements. We also attempt to identify factors that might contribute to the discrepancies between animal and human trials, and we propose recommendations that could help investigators avoid certain pitfalls in future clinical trials in traumatic brain injury.
Insights
Translational research in traumatic brain injury (TBI) faces challenges, as therapies successful in animal models often fail in human clinical trials. This review examines TBI trial status, discusses discrepancies, and offers recommendations for future research.
Area of Science:
- Neuroscience
- Clinical Research
- Translational Medicine
Background:
- Numerous potential therapies for human traumatic brain injury (TBI) have emerged from laboratory studies.
- Many of these interventions have advanced to human clinical trials, particularly for severe TBI.
Purpose of the Study:
- To review the current status of human TBI clinical trials.
- To analyze the discrepancies between animal study successes and human trial outcomes.
- To provide recommendations for improving future TBI clinical trials.
Main Methods:
- Review of completed and ongoing human clinical trials in severe TBI.
- Analysis of preclinical animal laboratory studies informing these trials.
- Identification of factors contributing to translational gaps.
Main Results:
- Many TBI therapies showing promise in animal models have yielded disappointing results in Phase III human trials.
- Several clinical trials have been terminated prematurely or are in various stages of testing.
Conclusions:
- Significant discrepancies exist between animal model efficacy and human clinical trial outcomes for TBI interventions.
- Future TBI clinical trials require improved design, criteria, and consideration of translational challenges to enhance success rates.
