Handbook of Neuroemergency Clinical Trials

Handbook of Neuroemergency Clinical Trials

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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.
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Product details

  • Hardback | 360 pages
  • 188 x 258 x 22mm | 938.95g
  • Academic Press Inc
  • San Diego, United States
  • English
  • 0126480826
  • 9780126480825

Table of contents

Chapter 1: Acute Ischemic Stroke

Chapter 2: Subarachnoid Hemorrhage

Chapter 3: Spontaneous Intracerebral Hemorrhage

Chapter 4: Traumatic Brain Injury

Chapter 5: Acute Seizures and Status Epilepticus

Chapter 6: Clinical Trials in Neuro-Ophthalmology

Chapter 7: Brain Resuscitation

Chapter 8: Clinical Trials in Brain Injury After Cardiac Arrest

Chapter 9: Efficient Dose-Response Finding Strategies for Acute Neuroemergency Treatments

Chapter 10: Biostatistical Issues in Neuroemergency Clinical Trials

Chapter 11: Data Safety and Monitoring Board: Role in Acute Neurological Trials

Chapter 12: Role of a Project Medical Officer in Acute Neuroemergency Clinical Trials

Chapter 13: Ethical Considerations in Neuroemergency Clinical Trials

Chapter 14: Industry Perspective on Drug Development

Chapter 15: Regulatory Perspective
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About Wayne M. Alves

Dr. Alves is Vice President of Clinical Operations at Evoke Pharmaceuticals, Inc. in Solana, California. He has held academic positions conducting basic clinical research in neuroemergency populations, and has served as consultant to numerous companies seeking to develop novel drugs. Dr. Skolnick is a Clinical Associate Professor of Neurosurgery at North Shore-LIJ School of Medicine in Manhasset, New York. He has a broad based experience with development responsibilities in neurology that includes Intracerebral hemorrhage, traumatic brain injury and stroke as well as more recently in the area of inflammation having worked on the development of multiple monoclonal antibodies in Psoriasis, Rheumatoid Arthritis, Crohn's disease and Ulcerative Colitis. Dr. Skolnick has previously worked as a clinical development consultant to pharmaceutical companies with a focus on early novel drug development.
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