Clinical Trials in Neurology : Design, Conduct, Analysis
ISBN: 9780521762595 | 0521762596
Edition: 1stFormat: Hardcover
Publisher: CAMBRIDGE UNIVERSITY PRESS
Pub. Date: 5/21/2012
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Clinical Trials in Neurology provides the tools to enhance the development of new treatments for neurologic diseases through introducing the reader to key concepts underpinning trials in the neurosciences. This comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.
Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the e... MORE
Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the e... MORE
| 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 | |
| Approach... MORE | |
| 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. |
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