During the 1990's, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury were offset by a history of disappointing results from Phase III clinical trials of novel neuroprotective drugs. Numerous novel compounds were "tested, and seemingly fell by the wayside. This book is intended to focus on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. The authors explore the issues facing research in this area and the strategies that might lead to future success in this critical area of unmet medical need. It represents a compendium of information gained from over 20 years of clinical trial experience in areas of acute neurology and neurosurgery. From the knowledge of clinical assessment using standardized tools, to the intricate design of difficult hyper-acute neuroemergencies trials, the reader will benefit from the authors' perspectives.
* Presents new perspectives on acute neuroemergency clinical trials * Includes insights from clinical pharmacology and industry perspectives * Discusses historical lessons learned from early and recent trials in acute neuroscience populations
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STROKE AND TRAUMA 1. Acute Ischemic Stroke (Christopher Bladin, Stephen Davis) 2. Subarachnoid Hemorrhage (Nader Pouratian, Aaron S. Dumont, Neal F. Kassell) 3. Spontaneous Intracerebral Hemorrhage (Michael D. Hill) 4. Traumatic Brain Injury (Lawrence F. Marshall, Wayne Alves) CENTRAL NERVOUS SYSTEM EMERGENCIES 5. Acute Seizures and Status Epilepticus (Susan T. Herman) 6. Clinical Trials in Neuro-opthamology (Laura Balcer, Madhura A. Tamhankar) 7. Brain Resuscitation (Edwin M. Nemoto) 8. Clinical Trials in Brain Injury after Cardiac Arrest (Romergryko G. Geocadin, Daniel F. Hanley) SPECIAL ISSUES IN ACUTE NEUROSCIENCE CLINICAL TRIALS 9. Efficient Dose-Response Finding Strategies for Acute Neuroemergency Treatments (Tom Parke, Michael Krams, Peter Mueller, Don Berry) 10. Biostatistical Issues in Neuroemergency Clinical Trials (Wayne M. Alves) 11. Data and Safety Monitoring Boards (Brett Skolnick) 12. Role of the Project Medical Officer (Joseph Kwentus) 13. Ethical Considerations (Wayne Alves) PERSPECTIVES ON NEUROEMERGENCY DRUG DEVELOPMENT 14. Industry Perspective on Drug Development (Thomas C. Wessel, Chris Gallen) 15. Regulatory Considerations (Lisa Travis)
