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Viewpoint |

Neuroprotection After Traumatic Brain Injury

Ralf Watzlawick, MD1; David W. Howells, PhD2; Jan M. Schwab, MD, PhD3,4
[+] Author Affiliations
1Department of Neurology and Experimental Neurology, Spinal Cord Injury Research, Charité–Universitätsmedizin Berlin, Berlin, Germany
2Faculty of Heath, School of Medicine, University of Tasmania, Medical Sciences Precinct, Hobart, Tasmania, Australia
3Spinal Cord Injury Division, Department of Neurology, The Ohio State University, Wexner Medical Center, Columbus
4Department of Neuroscience and Center for Brain and Spinal Cord Repair, The Ohio State University, Wexner Medical Center, Columbus
JAMA Neurol. 2016;73(2):149-150. doi:10.1001/jamaneurol.2015.3627.
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This Viewpoint discusses the role of animal studies in clinical trials of neuroprotection in traumatic brain injury.

Is research on traumatic brain injury (TBI) repeating the failures seen in studies on neuroprotection in stroke? Recent failures of pivotal randomized clinical trials on neuroprotection in TBI resemble the costly setbacks experienced by stroke investigators that resulted in the cessation of interventional pharmacological trials and withdrawal of investment by the pharmaceutical industry. Many hypotheses have been advanced to explain these translational failures, such as methodological failures leading to false-positive results in animal studies or false-negative results in clinical trials or that animal models might not sufficiently recapitulate human TBI. To combat translational nihilism about the failures of these trials, we intend to provide a constructive analysis of what could be learned to improve translational prediction of future trials on neuroprotection in TBI.

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Figure.
Empirical Evidence of Reporting Bias of Progesterone Interventions in Experimental Traumatic Brain Injury Studies

A, The Egger regression line unmasks underlying bias by not intersecting the origin (respectively analyzed published data set4). B, Contour-enhanced funnel plot7 illustrates reporting bias (eg, publication bias). In case of absent bias, the experiments (dots) would be symmetrically distributed. Experiments missing in the core of the plot might be due to publication bias while dots missing in the dark gray area might be due to other reasons such as study quality. It appears that there are missing neutral or negative unpublished data that give a more realistic appraisal of the effects of progesterone. Contour lines indicating conventional levels of statistical significance (eg, <.01; .01<P<.05; .05<P<.1; P>.1) are added to the funnel plot demarcating distinct significance areas.

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