Handbook of Neuroemergency Clinical Trials

Handbook of Neuroemergency Clinical Trials, 1st Edition

Handbook of Neuroemergency Clinical Trials, 1st Edition,Wayne Alves,Brett Skolnick,ISBN9780126480825

Alves   &   Skolnick   

Academic Press




260 X 184

Summarizes the state-of-the-practice of clinical trials in neurological emergencies.

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Key Features

* 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


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.


Researchers involved with the design of neuroemergency clinical trials, at research labs in universities, hospitals, major pharmaceutical (e.g., Astra Zeneca, GSK), biotechnology companies involved in these clinical areas.

Wayne 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.

Affiliations and Expertise

Valeant Pharmaceuticals Inc., Costa Mesa, CA, USA

Brett Skolnick

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.

Affiliations and Expertise

Novo Nordisk Pharmaceuticals, Inc., Princeton, NJ, USA

Handbook of Neuroemergency Clinical Trials, 1st Edition

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)

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)

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)

14. Industry Perspective on Drug Development (Thomas C. Wessel, Chris Gallen)
15. Regulatory Considerations (Lisa Travis)
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