Clinical Trials in Neurology

✍ Scribed by T. Hope, J. Savulescu (auth.), Dr. Roberto J. Guiloff MD, FRCP (eds.)

• Publisher: Springer-Verlag London
• Year: 2001
• Tongue: English
• Leaves: 536
• Edition: 1
• Category: Library

✦ Synopsis

Clinical Trials in Neurology comprehensively tackles the methodology and design of clinical trials in neurological disease. A general section deals with the ethical aspects, drug development and regulatory requirements, basic trial designs and the statistics used. A diseases section tackles specific aspects of disorders, focusing on the relevant ethical issues, outcome variables and experience with large multicentre trials.

✦ Table of Contents

Front Matter....Pages i-xvii
Front Matter....Pages 1-1
Ethical Considerations....Pages 3-15
Assessment Measures and Clinical Scales....Pages 17-28
Ethics, Outcome Variables and Clinical Scales: The Clinician’s Point of View....Pages 29-41
The Cochrane Collaboration Reviews in Neurology....Pages 43-51
Drug Development Stages....Pages 53-58
Drug Regulatory Requirements in the United Kingdom and Europe....Pages 59-69
Drug Regulatory Requirements in the United States....Pages 71-80
Quality Control and Data Monitoring: A Guide to Good Clinical Practice....Pages 81-94
Statistical Issues in Clinical Trials in Neurology....Pages 95-103
Analysis of Results: Statistical Principles....Pages 105-120
Survival Analysis....Pages 121-129
The Intention-to-Treat Principle for Clinical Trials....Pages 131-143
Statistical Analysis of Repeated-Measures Data with Drop-outs....Pages 145-156
The Role of Meta-analyses in Clinical Research: Uses and Limitations....Pages 157-168
Front Matter....Pages 169-169
Outcome Variables in Dementia Trials: Conceptual and Practical Issues....Pages 171-182
Dementia: Trial Design and Experience with Large Multicentre Trials....Pages 183-198
Cerebrovascular Disease: Basic Designs, Sample Sizes and Pitfalls....Pages 199-212
Clinical Trials in Stroke Prevention in North America....Pages 213-228
Cerebrovascular Disease: Experience Within Large Multicentre Trials....Pages 229-249
Epilepsy: Ethics, Outcome Variables and Clinical Scales....Pages 251-260
Front Matter....Pages 169-169
Epilepsy: Basic Designs, Sample Sizes and Experience with Large Multicentre Trials....Pages 261-269
Headache: Ethics, Outcome Variables and Clinical Studies....Pages 271-277
Headache: Basic Trial Designs, Sample Sizes and Pitfalls....Pages 279-290
Headache: Experience with Large Multicenter Trials in the Treatment of Migraine Attacks....Pages 291-297
Parkinson’s Disease: Outcome Variables and Clinical Scales....Pages 299-310
Parkinson’s Disease: A Review of Drug Trials....Pages 311-324
Parkinson’s Disease: Experience with Large Multicentre Trials....Pages 325-337
Tremor: Clinical Measurement of Impairment, Disability and Handicap....Pages 339-345
Tremor: Natural Behaviour, Trial Design and Physiological Outcome Measures....Pages 347-357
Multiple Sclerosis: Ethics, Outcome Variables and Clinical Scales....Pages 359-370
Multiple Sclerosis: Study Design, Sample Sizes and Pitfalls....Pages 371-385
Multiple Sclerosis: Experience with Large Clinical Trials....Pages 387-402
Motor Neurone Disease: Ethics, Outcome Variables and Clinical Scales....Pages 403-425
Motor Neurone Disease: Basic Designs, Sample Sizes and Pitfalls....Pages 427-450
Motor Neurone Disease: Experience with Large Multicentre Trials....Pages 451-463
Peripheral Neuropathies: Controlled Clinical Trials....Pages 465-478
Peripheral Neuropathies: Experience with Large Multicentre Trials....Pages 479-484
Disorders of the Neuromuscular Junction: Outcome Measures and Clinical Scales....Pages 485-499
Myasthenia Gravis: Basic Designs, Sample Sizes and Pitfalls....Pages 501-504
Myopathies: Ethics, Outcome Variables and Clinical Scales....Pages 505-513
Front Matter....Pages 169-169
Myopathies: Basic Designs, Sample Sizes and Pitfalls....Pages 515-528
Back Matter....Pages 529-542

✦ Subjects

Neurology; Pharmacology/Toxicology