Clinical Trials in Neurology

Description

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. 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