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9780521762595

Clinical Trials in Neurology: Design, Conduct, Analysis

by
  • ISBN13:

    9780521762595

  • ISBN10:

    0521762596

  • Edition: 1st
  • Format: Hardcover
  • Copyright: 2012-05-21
  • Publisher: Cambridge University Press

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Summary

Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.

Table of Contents

Preface
The Role of Clinical Trials in Therapy Development
The impact of clinical trials in neurology
The sequence of clinical development
Unique challenges in the development of therapies for neurological disorders
Concepts in Biostatistics and Clinical Measurement
Fundamentals of biostatistics
Bias and random error
Approaches to data analysis
Selecting outcome measures
Special Study Designs and Methods for Data Monitoring
Selection and futility designs
Adaptive designs across stages of therapeutic development
Crossover designs
Two period designs for evaluation of disease-modifying treatments
Enrichment designs Kathryn
Non-inferiority trials
Monitoring of clinical trials: interim monitoring, data monitoring committees, and group sequential methods applied to neurology
Clinical approaches to post-marketing drug safety assessment
Ethical Issues
Ethics in clinical trials involving the central nervous system: risk, benefit, justice, and integrity
The informed consent process: compliance and beyond Scott
Regulatory Perspectives
Evidentiary standards for neurologic drugs and biologics approval
Premarket reviews of neurological devices
Clinical Trials in Common Neurological Disorders
Parkinson's disease
Alzheimer's disease
Acute ischemic stroke
Multiple sclerosis
Amytrophic lateral sclerosis (ALS)
Epilepsy
Insomnia
Clinical Trial Planning and Implementation
Clinical trial planning: an academic and industry perspective
Clinical trial implementation, analysis and reporting: an academic and industry perspective
Academic-industry collaborations and compliance issues
Index
Table of Contents provided by Publisher. All Rights Reserved.

Supplemental Materials

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The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

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