Lost in translation: understanding the failure of the progesterone/traumatic brain injury Phase III trials

Written by Donald G Stein

Traumatic brain injury (TBI) remains a major public health problem. The Centers for Disease Control (CDC) reports that there are over 1.7 million cases of TBI annually in USA, accounting for 30% of injury-related deaths. The dozens of Phase III clinical trials evaluating neuroprotective therapeutics have all failed to provide evidence of benefit. This 100% failure rate represents a huge human and economic cost for society and for patients, for whom no effective neuroprotection is available [1]. One of the most promising agents, the neurosteroid progesterone, was recently tested in two independent, Phase III clinical trials. Progesterone seemed to have...

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