Handbook of Neuroemergency Clinical Trials

Front Cover
Wayne M. Alves, Brett E. Skolnick
Elsevier, Jan 18, 2006 - Medical - 360 pages
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

From inside the book

Contents

Chapter 1 Acute Ischemic Stroke
1
Chapter 2 Subarachnoid Hemorrhage
17
Chapter 3 Spontaneous Intracerebral Hemorrhage
45
Chapter 4 Traumatic Brain Injury
61
Chapter 5 Acute Seizures and Status Epilepticus
81
Chapter 6 Clinical Trials in NeuroOphthalmology
125
Chapter 7 Brain Resuscitation
147
Chapter 8 Clinical Trials in Brain Injury After Cardiac Arrest
159
Chapter 10 Biostatistical Issues in Neuroemergency Clinical Trials
205
Chapter 11 Data Safety and Monitoring Board Role in Acute Neurological Trials
229
Chapter 12 Role of a Project Medical Officer in Acute Neuroemergency Clinical Trials
247
Chapter 13 Ethical Considerations in Neuroemergency Clinical Trials
257
Chapter 14 Industry Perspective on Drug Development
275
Chapter 15 Regulatory Perspective
287
Index
319
Copyright

Chapter 9 Efficient DoseResponse Finding Strategies for Acute Neuroemergency Treatments
179

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Page 263 - An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Page 263 - A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; 2. A description of any reasonably foreseeable risks or discomforts to the subject; 3.
Page 263 - ... medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; 7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and 8.
Page 263 - A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable...
Page 263 - ... 3. Any additional costs to the subject that may result from participation in the research; 4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; 5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and 6.
Page 263 - A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained...
Page 172 - Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest.
Page 265 - Where research is covered by §§46.406 and 46.407 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
Page 263 - A description of any benefits to the subject or to others that may reasonably be expected from the research.

About the author (2006)

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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