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Handbook of neuroemergency clinical trials/ edited by Brett Evan Skolnick, Wayne M. Alves

Contributor(s): Material type: TextTextPublication details: London Elsevier Academic Press, c2018Edition: 2nd.editionDescription: 1 online resource(xix,386): illustrations; 25cmISBN:
  • 9780128040645
  • 9780128041017,
  • 0128041013
  • 0128040645
Uniform titles:
  • Handbook of neuroemergency clinical trials
Subject(s): LOC classification:
  • RC346.H36 2018
Contents:
CONTENTS Acute ischemic stroke / Bruce C.V. Campbell, Christopher F. Bladin, Geoffrey A. Donnan and Stephen M. Davis Subarachnoid hemorrhage / Robert Loch McDonald Clinical trials in spontaneous intracerebral hemorrhage / Fred Rincon and Stephan A. Mayer Imaging biomarkers in stroke trials / Hans Bakken and Max Wintermark Traumatic brain injury / Shamik Chakraborty, Brett E. Skolnick, Wayne M. Alves, Lawrence F. Marshall and Raj K. Narayan Improving approaches to evaluate efficacy and safety of drugs for tarumatic brain injury / Andrew I.R. Maas and David K. Menon Brain imaging in traumatic brain injury / Timothy I. Alves The use of blood-based biomarkers to improve the design of clinical trials of traumatic brain injury / Olena Y. Glushakova, Alexander V. Glushakov, Rebekah Mannix, Emmy R. Miller, Alex B. Valdka and Ronald L. Hayes Biostatistical issues in TBI clinical trials / Sharon D. Yeatts, Yuko Y. Palesch and Nancy Temkin Acute seizures and status epilepticus / Susan T. Herman Neuroemergencies in critical care patients / Jared A. Greenberg and Thomas P. Bleck Neuroemergency clinical trials / Stephen D. Silberstein and Thomas Berk Acute visual deficits / Clotilde Hainline, Alexandra Lloyd-Smith, Janet C. Rucker, Madhura A. Tamhankar and Laura J. Balcer Implications for new trials in acute ischemic stroke in the new era of endovascular therapy / Charlotte Zerna, Jessalyn K. Holodinsky, Mayank Goyal and Michael D. Hill The role of a project medical officer in acute neuroemergency clinical studies / Howard Levy Regulatory considerations / Steven B. Johnson Military perspectives on brain injuries / Geoffrey Ling, Nicole Draghic, Jamie Grimes and James Ecklund
Summary: Handbook of Neuroemergency Clinical Trials, Second Edition, focuses on the practice of clinical trials in acute neuroscience populations, or what have been called neuroemergencies. Neuroemergencies are complex, life-threatening diseases and disorders, often with devastating consequences, including death or disability. The overall costs are staggering in terms of annual incidence and costs associated with treatment and survival, yet despite their significance as public health issues, there are few drugs and devices available for definitive treatment. The book focuses on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. This volume provides neurologists, neuroscientists, and drug developers with a more complete understanding of the scientific and medical issues of relevance in designing and initiating clinical development plans for novel drugs intended for acute neuroscience populations. The editors provide the best understanding of the pitfalls associated with acute CNS drug development and the best information on how to approach and solve issues that have plagued drug development
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Includes Bibliographical references and Index

CONTENTS

Acute ischemic stroke / Bruce C.V. Campbell, Christopher F. Bladin, Geoffrey A. Donnan and Stephen M. Davis
Subarachnoid hemorrhage / Robert Loch McDonald
Clinical trials in spontaneous intracerebral hemorrhage / Fred Rincon and Stephan A. Mayer
Imaging biomarkers in stroke trials / Hans Bakken and Max Wintermark
Traumatic brain injury / Shamik Chakraborty, Brett E. Skolnick, Wayne M. Alves, Lawrence F. Marshall and Raj K. Narayan
Improving approaches to evaluate efficacy and safety of drugs for tarumatic brain injury / Andrew I.R. Maas and David K. Menon
Brain imaging in traumatic brain injury / Timothy I. Alves
The use of blood-based biomarkers to improve the design of clinical trials of traumatic brain injury / Olena Y. Glushakova, Alexander V. Glushakov, Rebekah Mannix, Emmy R. Miller, Alex B. Valdka and Ronald L. Hayes
Biostatistical issues in TBI clinical trials / Sharon D. Yeatts, Yuko Y. Palesch and Nancy Temkin
Acute seizures and status epilepticus / Susan T. Herman
Neuroemergencies in critical care patients / Jared A. Greenberg and Thomas P. Bleck
Neuroemergency clinical trials / Stephen D. Silberstein and Thomas Berk
Acute visual deficits / Clotilde Hainline, Alexandra Lloyd-Smith, Janet C. Rucker, Madhura A. Tamhankar and Laura J. Balcer
Implications for new trials in acute ischemic stroke in the new era of endovascular therapy / Charlotte Zerna, Jessalyn K. Holodinsky, Mayank Goyal and Michael D. Hill
The role of a project medical officer in acute neuroemergency clinical studies / Howard Levy
Regulatory considerations / Steven B. Johnson
Military perspectives on brain injuries / Geoffrey Ling, Nicole Draghic, Jamie Grimes and James Ecklund

Handbook of Neuroemergency Clinical Trials, Second Edition, focuses on the practice of clinical trials in acute neuroscience populations, or what have been called neuroemergencies. Neuroemergencies are complex, life-threatening diseases and disorders, often with devastating consequences, including death or disability. The overall costs are staggering in terms of annual incidence and costs associated with treatment and survival, yet despite their significance as public health issues, there are few drugs and devices available for definitive treatment. The book focuses on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. This volume provides neurologists, neuroscientists, and drug developers with a more complete understanding of the scientific and medical issues of relevance in designing and initiating clinical development plans for novel drugs intended for acute neuroscience populations. The editors provide the best understanding of the pitfalls associated with acute CNS drug development and the best information on how to approach and solve issues that have plagued drug development

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