Handbook Of Neuroemergency Clinical Trials

During the 1990s, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury, especially the neurochemical cascade associated with secondary brain injuries that occur most prominently with stroke and trauma, were offset by a history of disappointing results from Phase III clinical trials of novel neuroprotective drugs. The list of apparently ineffective compounds includes free radical scavengers, calcium channel blockers, and glutamate NMDA-receptor antagonists along with many other classes of molecular targets. By the mid-1990s over 100 NCEs were under development for a number of neurological disease indications, including about a dozen for traumatic brain injury. Yet, we still have no approved drugs for TBI, and only a single compound (r-TPA) has been approved for use in ischemic stroke. This disappointing experience made it clear that safe and effective drugs would be hard to come by and success at best would be incremental. The problem is coming to understand how to find a level playing field to fairly demonstrate the safety, efficacy and effectiveness of novel compounds targeted for neuroemergencies. Given the need to recognize the multiplicity of damage and outcomes in clinical trials, the need to understand factors that influence outcomes, and past clinical trials outcomes, what do we have to offer? The purpose of this volume is to explore the issues we face and the strategies that might lead to future success in this critical area of unmet medical need. The book is intended to focus on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials.Skolnick, Brett E. is the author of 'Handbook Of Neuroemergency Clinical Trials ', published 2006 under ISBN 9780126480825 and ISBN 0126480826.