Clinical trials for traumatic brain injury: Designs and challenges

Abstract

Traumatic brain injury (TBI) is a major public health problem affecting across all demographics. Despite its high impact on disability, mortality, and economics, currently there are no therapeutic drugs approved for the treatment of acute TBI. While many potential agents have shown effects in animal models, clinical trials in patients with TBI have shown little success and nearly 30 phase III clinical trials have failed to show efficacy for the treatment of TBI. This chapter discusses the challenges and designs of clinical trials along the critical path of developing new treatment for TBI. The overall objective is to promote effective clinical trial designs and optimize opportunities for developing new treatment for patients with TBI.