Handbook of Neuroemergency Clinical Trials

1st Edition

Editors: Brett Skolnick Wayne Alves Brett Skolnick
Hardcover ISBN: 9780126480825
eBook ISBN: 9780080454351
Imprint: Academic Press
Published Date: 9th December 2005
Page Count: 360
235.00 + applicable tax
180.00 + applicable tax
145.00 + applicable tax
215.00 + applicable tax
Unavailable
Compatible Not compatible
VitalSource PC, Mac, iPhone & iPad Amazon Kindle eReader
ePub & PDF Apple & PC desktop. Mobile devices (Apple & Android) Amazon Kindle eReader
Mobi Amazon Kindle eReader Anything else

Institutional Access


Description

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.

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

Readership

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.

Table of Contents

  • Foreword
  • Acknowledgments
  • Introduction
  • Chapter 1: Acute Ischemic Stroke

    • Publisher Summary
    • STROKE THROMBOLYSIS
    • ANTITHROMBOTIC DRUGS
    • NEUROPROTECTIVE DRUGS IN ACUTE ISCHEMIC STROKE
    • STUMBLING FROM THE BENCH TO BEDSIDE
    • FUTURE STROKE TRIALS: THE STROKE THERAPY ACADEMIC INDUSTRY ROUNDTABLE
    • CONCLUSIONS
  • Chapter 2: Subarachnoid Hemorrhage

    • Publisher Summary
    • ETIOLOGY, EPIDEMIOLOGY, AND NATURAL HISTORY
    • DIAGNOSIS, DEFINITION OF SUBPOPULATIONS, AND OUTCOMES ASSESSMENT
    • CURRENT MANAGEMENT OF ANEURYSMAL SAH
    • NOVEL, INVESTIGATIONAL, AND FAILED THERAPEUTICS
    • BIOLOGICAL MARKERS, SURROGATE ENDPOINTS, AND OUTCOMES
    • WHY DO SO MANY CLINICAL TRIALS FAIL?
    • EMERGENT CLINICAL TECHNOLOGIES AND METHODOLOGIES
    • CONCLUSION
  • Chapter 3: Spontaneous Intracerebral Hemorrhage

    • Publisher Summary
    • WHY ACUTE ICH CLINICAL TRIALS ARE DIFFICULT
    • ANIMAL MODELS: RELEVANT ISSUES FOR CLINICAL DEVELOPMENT PROGRAMS
    • EPIDEMIOLOGY AND NATURAL HISTORY
    • DIAGNOSIS AND SUBPOPULATIONS
    • CURRENT DISEASE MANAGEMENT
    • ISSUES IN CLINICAL PROTOCOL DEVELOPMENT
    • OUTCOMES
    • EFFICACY EVALUATION
    • GOLD STANDARD MEASURES
    • SURROGATE ENDPOINTS
    • SAFETY EVALUATION
  • Chapter 4: Traumatic Brain Injury

    • Publisher Summary
    • HISTORICAL CONTEXT OF TRAUMATIC BRAIN INJURY CLINICAL TRIALS
    • DRUG DEVELOPMENT PROGRAMS FOR TRAUMATIC BRAIN INJURY
    • TRAUMATIC BRAIN INJURY DRUGS AND TREATMENTS
    • EARLY CLINICAL TRIALS OF DRUGS AND BIOLOGICS FOR TRAUMATIC BRAIN INJURY
    • WHY HAVE TRAUMATIC BRAIN INJURY CLINICAL TRIALS PROVED DIFFICULT?
    • CURRENT ENVIRONMENT OF TRAUMATIC BRAIN INJURY DRUG DEVELOPMENT
    • KEY ISSUES IN TRAUMATIC BRAIN INJURY CLINICAL TRIALS DESIGN AND ANALYSIS</

Details

No. of pages:
360
Language:
English
Copyright:
© Academic Press 2006
Published:
Imprint:
Academic Press
eBook ISBN:
9780080454351
Hardcover ISBN:
9780126480825

About the Editor

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

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

Reviews

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.