Handbook of Neuroemergency Clinical Trials
Academic Press Inc (Verlag)
978-0-12-648082-5 (ISBN)
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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.
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.
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
| Erscheint lt. Verlag | 18.1.2006 |
|---|---|
| Verlagsort | San Diego |
| Sprache | englisch |
| Maße | 184 x 260 mm |
| Gewicht | 910 g |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Neurologie |
| ISBN-10 | 0-12-648082-6 / 0126480826 |
| ISBN-13 | 978-0-12-648082-5 / 9780126480825 |
| Zustand | Neuware |
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